A federal lawsuit filed by James Thompson in the United States District Court for the Southern District of Texas seeks monetary damages for the loss of vision allegedly caused by the use of Viagra, Pfizer�s blockbuster erectile dysfunction (ED) drug. Mr. Thompson also seeks class- action certification on behalf of all other men injured by the drug.
The Food and Drug Administration has received over 40 reports of blindness in men taking Viagra, Levitra, or Cialis. This type of irreversible blindness known as non-arteritic anterior ischemic optic neuropathy (NAION) restricts the flow of oxygenated blood to the optic nerve.
Pfizer has taken the position that its drug does not cause NAION and that a class-action is inappropriate. The company claims that NAION shares a number of common risk factors with ED, including high blood pressure, diabetes, and high cholesterol.
The lawsuit charges that Pfizer failed to warn the public that taking Viagra could cause NAION.
Tuesday, March 18, 2008
Viagra Linked to Vision Problems FDA Studies Reports, Discusses Disclosure
An investigation into whether Viagra and other popular impotence drugs may cause permanent eye damage is unlikely to lead to a recall, federal officials and medical experts said Friday, but could prompt new warnings.
The Food and Drug Administration is looking into 38 reports of eye damage in men who took Viagra, four involving Cialis, and one with Levitra. About 30 million men worldwide have taken the drugs.
"We haven't been able to determine that there is a cause and effect due to the medication," FDA spokeswoman Suzanne Trevino said. "But we are taking it seriously."
Most of the men who suffered eye damage did not go completely blind but lost part of their vision in one eye. Complicating the FDA's investigation, many of the patients had other risk factors, such as high blood pressure, that would make them vulnerable to the particular kind of eye problem.
The condition nonarteritic anterior ischemic optic neuropathy, or NAION involves damage to the optic nerve caused by an interruption of blood supply.
Trevino said the FDA is talking with Pfizer Inc., Viagra's manufacturer, about formally disclosing the risk in its prescribing literature for doctors. Eli Lilly & Co., which makes Cialis, recently changed its information to acknowledge reports of eye damage.
Dr. Howard Pomeranz, a professor of ophthalmology at the University of Minnesota, reported a suspected link between Viagra and eye damage in a medical journal article published in March.
"This particular eye problem should be added to the list of side effects that patients have access to," Pomeranz said Friday. But, he added, the medical evidence at this point would not warrant withdrawing the drug.
"I'm not recommending that men stop taking this drug," he said. "It's very good for what it's prescribed for."
However, Pomeranz said, patients who already have NAION in one eye should be strongly cautioned about the risk of using Viagra. And any patient who experiences blurriness or a loss of peripheral vision should stop taking such medications and consult a doctor immediately.
For patients who want to know whether they may be at risk, an eye exam may help answer the question. Doctors say one risk factor for NAION is tightly bundled nerves and blood vessels in the back of the eye. An eye doctor can identify that condition.
Medical factors that increase the risk of NAION include high blood pressure, high cholesterol and diabetes. Older people also are more likely to have the problem.
Dr. Michael Lee, a neuro-ophthalmologist at the Cleveland Clinic Foundation, treated a 67-year-old architect who had received a sample pack of Cialis from his primary care doctor.
One morning, two hours after taking the drug, the patient noticed a blurry patch in the bottom of his field of vision in his right eye, Lee said. His vision recovered by the next morning.
The patient took the drug three more times, with the same effect. Then he took another dose. That time, the blurry patch did not go away. The damage was permanent, Lee said.
The patient had two risk factors for NAION: high cholesterol and an especially small channel for blood vessels that run through the optic nerve behind the eye.
NAION strikes fewer than 10 people out of every 100,000 over age 50, Lee said.
In a statement, Pfizer said there was no evidence that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take the drug.
"Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors," the company said. "This makes it impossible to determine whether these events are caused by the patient's underlying risk factors, anatomical defects, Viagra, or a combinations of these factors."
Eli Lilly spokeswoman Kindra Strupp said the company has updated its prescribing literature to reflect the reports of NAION. But "we don't see any cause-and-effect link," she added. "It certainly has not been established at this point."
Pomeranz said he disagreed with the drug companies' assertion that any association between the medications and eye damage was coincidental. In the 20 or so cases he reviewed, the onset of eye problems followed the patient's taking of Viagra -- usually by several hours, but sometimes by as few as 45 minutes.
"It's really the time connection between when the patient took the drug and when he noticed the loss of vision that convinces me there's a link," Pomeranz said.
His medical journal article conceded that "a definite causal relationship cannot be established at this time." But in view of the ever-growing use of such drugs, he wrote, the FDA must investigate.
"It is critical that irreversible ocular side effects such as NAION be ruled out in this class of drugs," he wrote.
The situation presents a common dilemma for the FDA: Although drugs may be tested on several thousand people before their approval, rare side effects may not emerge until many more have used the medication.
Some doctors said Friday that patients inquiring about the potential risk of eye damage were not overly alarmed.
"It's way out of proportion," said Dr. Steven Schwartz, chief of the retina division at the Jules Stein Eye Institute at UCLA. He sent three cases to the FDA, but as in the other reports received by the agency, the patients had other risk factors for NAION.
Side effects
Federal health officials are examining rare reports of blindness among some men using Viagra and Cialis. The warning labels of both impotence drugs, as well as Levitra, currently list the following side effects, according to the drugs' Web sites:
Viagra: "Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light or blurred vision."
Cialis: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."
Levitra: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."
The Food and Drug Administration is looking into 38 reports of eye damage in men who took Viagra, four involving Cialis, and one with Levitra. About 30 million men worldwide have taken the drugs.
"We haven't been able to determine that there is a cause and effect due to the medication," FDA spokeswoman Suzanne Trevino said. "But we are taking it seriously."
Most of the men who suffered eye damage did not go completely blind but lost part of their vision in one eye. Complicating the FDA's investigation, many of the patients had other risk factors, such as high blood pressure, that would make them vulnerable to the particular kind of eye problem.
The condition nonarteritic anterior ischemic optic neuropathy, or NAION involves damage to the optic nerve caused by an interruption of blood supply.
Trevino said the FDA is talking with Pfizer Inc., Viagra's manufacturer, about formally disclosing the risk in its prescribing literature for doctors. Eli Lilly & Co., which makes Cialis, recently changed its information to acknowledge reports of eye damage.
Dr. Howard Pomeranz, a professor of ophthalmology at the University of Minnesota, reported a suspected link between Viagra and eye damage in a medical journal article published in March.
"This particular eye problem should be added to the list of side effects that patients have access to," Pomeranz said Friday. But, he added, the medical evidence at this point would not warrant withdrawing the drug.
"I'm not recommending that men stop taking this drug," he said. "It's very good for what it's prescribed for."
However, Pomeranz said, patients who already have NAION in one eye should be strongly cautioned about the risk of using Viagra. And any patient who experiences blurriness or a loss of peripheral vision should stop taking such medications and consult a doctor immediately.
For patients who want to know whether they may be at risk, an eye exam may help answer the question. Doctors say one risk factor for NAION is tightly bundled nerves and blood vessels in the back of the eye. An eye doctor can identify that condition.
Medical factors that increase the risk of NAION include high blood pressure, high cholesterol and diabetes. Older people also are more likely to have the problem.
Dr. Michael Lee, a neuro-ophthalmologist at the Cleveland Clinic Foundation, treated a 67-year-old architect who had received a sample pack of Cialis from his primary care doctor.
One morning, two hours after taking the drug, the patient noticed a blurry patch in the bottom of his field of vision in his right eye, Lee said. His vision recovered by the next morning.
The patient took the drug three more times, with the same effect. Then he took another dose. That time, the blurry patch did not go away. The damage was permanent, Lee said.
The patient had two risk factors for NAION: high cholesterol and an especially small channel for blood vessels that run through the optic nerve behind the eye.
NAION strikes fewer than 10 people out of every 100,000 over age 50, Lee said.
In a statement, Pfizer said there was no evidence that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take the drug.
"Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors," the company said. "This makes it impossible to determine whether these events are caused by the patient's underlying risk factors, anatomical defects, Viagra, or a combinations of these factors."
Eli Lilly spokeswoman Kindra Strupp said the company has updated its prescribing literature to reflect the reports of NAION. But "we don't see any cause-and-effect link," she added. "It certainly has not been established at this point."
Pomeranz said he disagreed with the drug companies' assertion that any association between the medications and eye damage was coincidental. In the 20 or so cases he reviewed, the onset of eye problems followed the patient's taking of Viagra -- usually by several hours, but sometimes by as few as 45 minutes.
"It's really the time connection between when the patient took the drug and when he noticed the loss of vision that convinces me there's a link," Pomeranz said.
His medical journal article conceded that "a definite causal relationship cannot be established at this time." But in view of the ever-growing use of such drugs, he wrote, the FDA must investigate.
"It is critical that irreversible ocular side effects such as NAION be ruled out in this class of drugs," he wrote.
The situation presents a common dilemma for the FDA: Although drugs may be tested on several thousand people before their approval, rare side effects may not emerge until many more have used the medication.
Some doctors said Friday that patients inquiring about the potential risk of eye damage were not overly alarmed.
"It's way out of proportion," said Dr. Steven Schwartz, chief of the retina division at the Jules Stein Eye Institute at UCLA. He sent three cases to the FDA, but as in the other reports received by the agency, the patients had other risk factors for NAION.
Side effects
Federal health officials are examining rare reports of blindness among some men using Viagra and Cialis. The warning labels of both impotence drugs, as well as Levitra, currently list the following side effects, according to the drugs' Web sites:
Viagra: "Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light or blurred vision."
Cialis: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."
Levitra: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."
FDA Was Told of Viagra-Blindness Link Months Ago
More than 13 months before a scientific journal reported that Viagra had been linked to a rare form of blindness in some men, a Food and Drug Administration safety officer made the same observation from monitoring adverse event reports and told her supervisors that doctors and patients should be warned of the findings.
Her recommendation was well received, she told congressional investigators, but nothing happened. The FDA issued no public notice or proposed changes to the Viagra label. That came only following widespread publicity last month about the journal article and public concerns about the possible blindness-Viagra link.
The safety officer's experience was outlined in a letter last week to FDA Acting Commissioner Lester M. Crawford from Sen. Charles E. Grassley (R-Iowa), who said the agency had moved far too slowly on an emerging safety concern.
Criticism of the FDA's response to potentially harmful drug side effects has been frequent and sharp since Merck & Co. took its popular arthritis painkiller, Vioxx, off the market last fall after studies indicated that it increased the risk of heart attacks and strokes. The FDA has sought to tighten its drug safety oversight since then, but some critics say the agency is doing too little and still puts more emphasis on reviewing and approving new drugs than on safety concerns.
"I am troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label," Grassley wrote. He said the agency's Office of New Drugs (OND) had done nothing "despite OND's knowledge of the blindness risks since January 2004 and general agreement among FDA staff last spring that the label should be updated."
Grassley also wrote that the safety officer, whose name was not disclosed, explained the agency's inaction by saying the Office of New Drugs "is under such time pressure to approve new drugs, often safety concerns needed to be 'fit in' where they could."
"What we appear to have here, Dr. Crawford, is yet another example of the 'separate but unequal' relationship" between the Office of New Drugs and the Office of Drug Safety, Grassley wrote.
Researchers remain uncertain whether Viagra and other impotence drugs pose a significant risk of blindness. Pfizer Inc., which makes the drug, says the side effect has not appeared in any of its 103 clinical trials of Viagra involving 13,000 patients and that the 23 million users have not reported an increased risk of blindness.
Late last month, however, after the possible link was reported in the Journal of Neuro-Ophthalmology, FDA spokeswoman Susan Cruzan said, "We take this seriously, and the FDA is working with the sponsors to make sure the public is aware of this so they can take it into consideration." The journal study examined seven cases where men suffered an unusual form of sudden blindness within 36 hours of taking Viagra.
On Monday, Pfizer said in a statement that it does not believe there is a causal relationship between Viagra and blindness but that it will add information about the possibility to its label. The company said the FDA had asked the makers of all impotence drugs to do the same.
"There is no evidence that Viagra causes blindness or any other serious ocular condition," said Joseph Feczko, Pfizer's chief medical officer. "Men taking Viagra are at no greater risk for blindness than men of similar age and health not taking the medicine."
In all, the FDA has said, 38 Viagra users and five users of other impotence drugs reported a sudden and permanent blindness in one eye called non-arteritic anterior ischemic optic neuropathy, or NAION. In a report Monday, CBS News said that the number is much higher, and that more than 800 patients and doctors have reported eye problems to the FDA after using Viagra over the past four years, with more than 140 cases of partial or total blindness. While these "adverse event" reports do not prove a causal link between the drugs and sudden blindness, drug safety experts look to them for trends and patterns.
This form of sudden blindness is caused by the blockage of blood flow to the optic nerve and is most common in older people, who disproportionately use Viagra. An estimated 1,000 to 6,000 Americans suffer an optic blockage each year.
Grassley's letter said the FDA safety officer first brought her concerns to the Office of New Drugs in January 2004. That was followed by a more formal draft safety "consult" in March 2004 and a final report the next month.
The letter paraphrases internal FDA documents as saying that Pfizer "resisted the FDA's initial request to update the Viagra label to include information about the NAION risks." Pfizer spokesman Mariann Caprino said the company does not comment on its interactions with the FDA. Earlier, another Pfizer spokesman said the company contacted the FDA about the blindness cases in March, after the journal report was published.
Grassley's letter also questions whether the FDA's adverse event reporting system would be capable of detecting NAION cases that might be associated with Viagra. Until now, it said, few doctors who prescribe Viagra would know to ask patients about vision problems, and few ophthalmologists who treat sudden blindness would know to ask about Viagra use. FDA officials said they had no comment on Grassley's letter.
All three impotence drugs on the market, Viagra, Cialis and Levitra, already warn users that the drug can cause minor vision changes that include blurring, sensitivity to light and the presence of a bluish hue. The makers of Cialis, Eli Lilly & Co. and Icos Corp., have voluntarily added a notice about the risk of sudden blindness to their label
Her recommendation was well received, she told congressional investigators, but nothing happened. The FDA issued no public notice or proposed changes to the Viagra label. That came only following widespread publicity last month about the journal article and public concerns about the possible blindness-Viagra link.
The safety officer's experience was outlined in a letter last week to FDA Acting Commissioner Lester M. Crawford from Sen. Charles E. Grassley (R-Iowa), who said the agency had moved far too slowly on an emerging safety concern.
Criticism of the FDA's response to potentially harmful drug side effects has been frequent and sharp since Merck & Co. took its popular arthritis painkiller, Vioxx, off the market last fall after studies indicated that it increased the risk of heart attacks and strokes. The FDA has sought to tighten its drug safety oversight since then, but some critics say the agency is doing too little and still puts more emphasis on reviewing and approving new drugs than on safety concerns.
"I am troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label," Grassley wrote. He said the agency's Office of New Drugs (OND) had done nothing "despite OND's knowledge of the blindness risks since January 2004 and general agreement among FDA staff last spring that the label should be updated."
Grassley also wrote that the safety officer, whose name was not disclosed, explained the agency's inaction by saying the Office of New Drugs "is under such time pressure to approve new drugs, often safety concerns needed to be 'fit in' where they could."
"What we appear to have here, Dr. Crawford, is yet another example of the 'separate but unequal' relationship" between the Office of New Drugs and the Office of Drug Safety, Grassley wrote.
Researchers remain uncertain whether Viagra and other impotence drugs pose a significant risk of blindness. Pfizer Inc., which makes the drug, says the side effect has not appeared in any of its 103 clinical trials of Viagra involving 13,000 patients and that the 23 million users have not reported an increased risk of blindness.
Late last month, however, after the possible link was reported in the Journal of Neuro-Ophthalmology, FDA spokeswoman Susan Cruzan said, "We take this seriously, and the FDA is working with the sponsors to make sure the public is aware of this so they can take it into consideration." The journal study examined seven cases where men suffered an unusual form of sudden blindness within 36 hours of taking Viagra.
On Monday, Pfizer said in a statement that it does not believe there is a causal relationship between Viagra and blindness but that it will add information about the possibility to its label. The company said the FDA had asked the makers of all impotence drugs to do the same.
"There is no evidence that Viagra causes blindness or any other serious ocular condition," said Joseph Feczko, Pfizer's chief medical officer. "Men taking Viagra are at no greater risk for blindness than men of similar age and health not taking the medicine."
In all, the FDA has said, 38 Viagra users and five users of other impotence drugs reported a sudden and permanent blindness in one eye called non-arteritic anterior ischemic optic neuropathy, or NAION. In a report Monday, CBS News said that the number is much higher, and that more than 800 patients and doctors have reported eye problems to the FDA after using Viagra over the past four years, with more than 140 cases of partial or total blindness. While these "adverse event" reports do not prove a causal link between the drugs and sudden blindness, drug safety experts look to them for trends and patterns.
This form of sudden blindness is caused by the blockage of blood flow to the optic nerve and is most common in older people, who disproportionately use Viagra. An estimated 1,000 to 6,000 Americans suffer an optic blockage each year.
Grassley's letter said the FDA safety officer first brought her concerns to the Office of New Drugs in January 2004. That was followed by a more formal draft safety "consult" in March 2004 and a final report the next month.
The letter paraphrases internal FDA documents as saying that Pfizer "resisted the FDA's initial request to update the Viagra label to include information about the NAION risks." Pfizer spokesman Mariann Caprino said the company does not comment on its interactions with the FDA. Earlier, another Pfizer spokesman said the company contacted the FDA about the blindness cases in March, after the journal report was published.
Grassley's letter also questions whether the FDA's adverse event reporting system would be capable of detecting NAION cases that might be associated with Viagra. Until now, it said, few doctors who prescribe Viagra would know to ask patients about vision problems, and few ophthalmologists who treat sudden blindness would know to ask about Viagra use. FDA officials said they had no comment on Grassley's letter.
All three impotence drugs on the market, Viagra, Cialis and Levitra, already warn users that the drug can cause minor vision changes that include blurring, sensitivity to light and the presence of a bluish hue. The makers of Cialis, Eli Lilly & Co. and Icos Corp., have voluntarily added a notice about the risk of sudden blindness to their label
FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems Possibly Associated with These Drugs
The Food and Drug Administration (FDA) has approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
The FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA states that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
The FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA states that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
FDA Orders Warning Label on Viagra
The government on Friday ordered warnings onto the labels of Viagra and two other impotence drugs after some users developed a form of blindness. The Food and Drug Administration's move comes as the agency is under intense pressure to investigate more aggressively and warn the public about drug side effects.
At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called NAION or non-arteritic anterior ischemic optic neuropathy.
NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Moreover, risk factors include diabetes and heart disease, two of the leading causes of impotence.
The FDA has 43 reports of NAION among the impotence drug users: 38 for Viagra, four for Cialis and one for Levitra. They include varying degrees of vision loss, including blindness.
Those are rare numbers, given that Viagra alone has been used by 23 million men worldwide since its approval in 1998, according to maker Pfizer Inc.
"It is not possible to determine whether these oral medicines for erectile dysfunction were the cause," or whether other health conditions triggered NAION in the men, the FDA said in a statement Friday.
In addition to heart disease and diabetes, risk factors include being over age 50, high blood pressure, high cholesterol and smoking.
But FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes, and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode.
Cialis is marketed by Eli Lilly & Co. and ICOS Corp. Levitra is sold by GlaxoSmithKline PLC and Schering-Plough Corp. in the United States, and by Bayer AG elsewhere.
At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called NAION or non-arteritic anterior ischemic optic neuropathy.
NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Moreover, risk factors include diabetes and heart disease, two of the leading causes of impotence.
The FDA has 43 reports of NAION among the impotence drug users: 38 for Viagra, four for Cialis and one for Levitra. They include varying degrees of vision loss, including blindness.
Those are rare numbers, given that Viagra alone has been used by 23 million men worldwide since its approval in 1998, according to maker Pfizer Inc.
"It is not possible to determine whether these oral medicines for erectile dysfunction were the cause," or whether other health conditions triggered NAION in the men, the FDA said in a statement Friday.
In addition to heart disease and diabetes, risk factors include being over age 50, high blood pressure, high cholesterol and smoking.
But FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes, and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode.
Cialis is marketed by Eli Lilly & Co. and ICOS Corp. Levitra is sold by GlaxoSmithKline PLC and Schering-Plough Corp. in the United States, and by Bayer AG elsewhere.
Health Canada Advises About Vision Problems Possibly Associated With Viagra, Cialis and Levitra
Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible. Risk factors for NAION include:
* age greater than 50 years
* heart disease
* high blood pressure
* high cholesterol
* diabetes
* smoking
* certain pre-existing eye problems
An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.
Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer Inc. (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.
While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible. Risk factors for NAION include:
* age greater than 50 years
* heart disease
* high blood pressure
* high cholesterol
* diabetes
* smoking
* certain pre-existing eye problems
An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.
Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer Inc. (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.
While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.
Health Canada Issues Advisory Concerning Vision Problems Possibly Associated with Viagra, Cialis, and Levitra
In a release which follows on the heels of a July 8 announcement by the U.S. FDA that it was approving updated labeling for Viagra, Cialis, and Levitra to reflect the possible link between these Erectile Dysfunction medications and sudden vision loss, Health Canada issued a similar Advisory yesterday.
All of this began on May 27, when the FDA disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra).
To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists was enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION.
On July 8, the FDA approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION .
The FDA advised patients to stop taking these medicines, and call a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA stated that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
The new labeling information is available along with additional information for healthcare providers and consumers online at:
Viagra
Levitra
Cialis
The Advisory from Health Canada follows:
“Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible.
Risk factors for NAION include:
• age greater than 50 years
• heart disease
• high blood pressure
• high cholesterol
• diabetes
• smoking
• certain pre-existing eye problems
An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.
Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.
While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.”
All of this began on May 27, when the FDA disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra).
To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists was enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION.
On July 8, the FDA approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION .
The FDA advised patients to stop taking these medicines, and call a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA stated that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
The new labeling information is available along with additional information for healthcare providers and consumers online at:
Viagra
Levitra
Cialis
The Advisory from Health Canada follows:
“Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible.
Risk factors for NAION include:
• age greater than 50 years
• heart disease
• high blood pressure
• high cholesterol
• diabetes
• smoking
• certain pre-existing eye problems
An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.
Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.
While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.”
Get Eye Test Before Using Viagra: Expert
Men should have their eyes checked before taking impotency drugs like Viagra, or risk going blind, a leading international ophthalmologist says.
Professor Neil Miller, of Johns Hopkins Hospital in Baltimore, said drugs such as Viagra, Cialis and Levitra had the potential to lower blood pressure, putting some patients at risk of having a stroke in the optic nerve.
He was talking outside an ophthalmology conference on the Gold Coast which was told of two Australian cases of men in their 60s who had suffered vision impairment after taking Viagra.
"Almost nobody goes completely blind, but they can have significant visual loss in one eye," Prof Miller said.
Although there's been less than 20 cases of vision loss reported among people taking the drugs out of many millions of prescriptions worldwide, he said the extent of the problem was difficult to assess.
"We haven't asked the patients the right questions and not every ophthalmologist who sees a case winds up reporting it," Prof Miller said.
Another complication is that patients who suffer vision loss of this type a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) are of an age where they could be at risk anyway from the effects of hardening of the arteries, hypertension, diabetes or other conditions.
For example, ophthalmologist Peter Cranstoun said the two Australian cases reported by a visiting medical officer at Brisbane's Princess Alexandra Hospital had other health issues which may have impacted on their eye problems.
Prof Miller recommended patients considering going on an impotency drug should have an eye examination to assess their risk of an optic nerve stroke.
He said people who developed NAION usually had a smaller than normal optic nerve head, also called the optic disc.
Optic nerve heads normally look like a circle with a depression in the centre, known as the optic cup.
In most people, the cup takes up about 30 to 50 per cent of the diameter of the optic nerve head.
Prof Miller said those at risk of NAION also had a much smaller optic cup.
"The implication is that all the nerve fibres are crowded into a much smaller space," he explained.
"You can think of it as a room with say, 100 people in it.
"Put those 100 people into a room that's half that size and they're all crowded together. They can't breathe, they can't walk around.
"Then something happens that reduces the oxygen and that's what tips them over the brink."
Prof Miller said impotency drugs worked by dilating blood vessels, allowing more blood into the penis, causing an erection.
"But they also dilate general blood vessels and when that happens, blood pressure can fall."
Dr Cranstoun suggested general practitioners should examine patients' eyes before prescribing Viagra.
"If there's a question about the optic disc - what we call a disc at risk - then they could ask an ophthalmologist for an opinion," he said.
Queensland branch members of the Royal Australian and New Zealand College of Ophthalmologists are on the Gold Coast for their annual scientific meeting.
The US Food and Drug Administration recently ordered that labels for impotency drugs contain a warning about vision loss.
A spokesman for Pfizer Australia, which markets Viagra, said the labels on the drugs sold in Australia had been amended to reflect the "extremely rare" possibility of developing NAION.
He said the amendments followed consultation with the Therapeutic Goods Administration (TGA).
Professor Neil Miller, of Johns Hopkins Hospital in Baltimore, said drugs such as Viagra, Cialis and Levitra had the potential to lower blood pressure, putting some patients at risk of having a stroke in the optic nerve.
He was talking outside an ophthalmology conference on the Gold Coast which was told of two Australian cases of men in their 60s who had suffered vision impairment after taking Viagra.
"Almost nobody goes completely blind, but they can have significant visual loss in one eye," Prof Miller said.
Although there's been less than 20 cases of vision loss reported among people taking the drugs out of many millions of prescriptions worldwide, he said the extent of the problem was difficult to assess.
"We haven't asked the patients the right questions and not every ophthalmologist who sees a case winds up reporting it," Prof Miller said.
Another complication is that patients who suffer vision loss of this type a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) are of an age where they could be at risk anyway from the effects of hardening of the arteries, hypertension, diabetes or other conditions.
For example, ophthalmologist Peter Cranstoun said the two Australian cases reported by a visiting medical officer at Brisbane's Princess Alexandra Hospital had other health issues which may have impacted on their eye problems.
Prof Miller recommended patients considering going on an impotency drug should have an eye examination to assess their risk of an optic nerve stroke.
He said people who developed NAION usually had a smaller than normal optic nerve head, also called the optic disc.
Optic nerve heads normally look like a circle with a depression in the centre, known as the optic cup.
In most people, the cup takes up about 30 to 50 per cent of the diameter of the optic nerve head.
Prof Miller said those at risk of NAION also had a much smaller optic cup.
"The implication is that all the nerve fibres are crowded into a much smaller space," he explained.
"You can think of it as a room with say, 100 people in it.
"Put those 100 people into a room that's half that size and they're all crowded together. They can't breathe, they can't walk around.
"Then something happens that reduces the oxygen and that's what tips them over the brink."
Prof Miller said impotency drugs worked by dilating blood vessels, allowing more blood into the penis, causing an erection.
"But they also dilate general blood vessels and when that happens, blood pressure can fall."
Dr Cranstoun suggested general practitioners should examine patients' eyes before prescribing Viagra.
"If there's a question about the optic disc - what we call a disc at risk - then they could ask an ophthalmologist for an opinion," he said.
Queensland branch members of the Royal Australian and New Zealand College of Ophthalmologists are on the Gold Coast for their annual scientific meeting.
The US Food and Drug Administration recently ordered that labels for impotency drugs contain a warning about vision loss.
A spokesman for Pfizer Australia, which markets Viagra, said the labels on the drugs sold in Australia had been amended to reflect the "extremely rare" possibility of developing NAION.
He said the amendments followed consultation with the Therapeutic Goods Administration (TGA).
UAB study links vision loss with Viagra, Cialis use
A study from the University of Alabama at Birmingham indicates men with a history of heart attack who use the erectile dysfunction medications Viagra or Cialis may be at increased risk for vision loss.
The study, published in the British Journal of Ophthalmology, indicates a link between use of the medications and non-arteritic anterior ischaemic optic neuropathy (NAION), a condition affecting up to 6,000 people each year in the United States.
The condition, described as a "stroke of the eye," can cause vision loss in one or both eyes. It is caused by insufficient blood flow to the optic nerve head, damaging the nerve and leading to permanent vision loss.
Gerald McGwin, an associate professor of epidemiology and ophthalmology at UAB and the lead author of the study, says his team's research uncovered a "strong link" between the medications and NAION incidents in men with a history of heart attack.
"We found similar results in men with hypertension which, while not as dramatic, are substantial enough to indicate that men with a history of either heart attack or hypertension should be warned of the risks of NAION before use of these medications," McGwin said.
He notes this is the first study to investigate the association since the U.S. Food and Drug Administration suggested in 2005 a link might exist.
The drug Levitra did not appear on the market until after the study began, so it is not included in the findings.
The study was funded by Research to Prevent Blindness Inc., and the Eyesight Foundation of Alabama.
The study, published in the British Journal of Ophthalmology, indicates a link between use of the medications and non-arteritic anterior ischaemic optic neuropathy (NAION), a condition affecting up to 6,000 people each year in the United States.
The condition, described as a "stroke of the eye," can cause vision loss in one or both eyes. It is caused by insufficient blood flow to the optic nerve head, damaging the nerve and leading to permanent vision loss.
Gerald McGwin, an associate professor of epidemiology and ophthalmology at UAB and the lead author of the study, says his team's research uncovered a "strong link" between the medications and NAION incidents in men with a history of heart attack.
"We found similar results in men with hypertension which, while not as dramatic, are substantial enough to indicate that men with a history of either heart attack or hypertension should be warned of the risks of NAION before use of these medications," McGwin said.
He notes this is the first study to investigate the association since the U.S. Food and Drug Administration suggested in 2005 a link might exist.
The drug Levitra did not appear on the market until after the study began, so it is not included in the findings.
The study was funded by Research to Prevent Blindness Inc., and the Eyesight Foundation of Alabama.
Viagra, Cialis, Levitra Information Sheet Warns o f Sudden Hearing Loss
Doctors who prescribe Viagra, Cialis and Levitra will need to read up on a new information sheet released by the Food & Drug Administration (FDA) regarding sudden hearing loss associated with the erectile dysfunction drugs. Last month, the FDA warned that Viagra, Levitra, and Cialis have been connected with more than two dozen instances of sudden hearing loss. Those reports prompted the FDA to announce that the labels on these erectile dysfunction drugs would bear new warnings about this potential side effect.
Following the publication of a report in the Journal of Laryngology and Otology, the FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking Viagra, Levitra and Cialis. Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.
The FDA is advising physicians who prescribe Viagra, Levitra or Cialis for erectile dysfunction to tell their patients to immediately stop taking the drug if they experience any sudden decrease or loss of hearing and seek prompt medical attention. The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas t
he previous label simply stated “deafness” as a possible side effect.
This is the second time that the Viagra, Levitra and Cialis labels have been changed to warn of a serious side effect. In 2005, warnings about vision loss associated with the drugs were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
Following the publication of a report in the Journal of Laryngology and Otology, the FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking Viagra, Levitra and Cialis. Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.
The FDA is advising physicians who prescribe Viagra, Levitra or Cialis for erectile dysfunction to tell their patients to immediately stop taking the drug if they experience any sudden decrease or loss of hearing and seek prompt medical attention. The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas t
he previous label simply stated “deafness” as a possible side effect.
This is the second time that the Viagra, Levitra and Cialis labels have been changed to warn of a serious side effect. In 2005, warnings about vision loss associated with the drugs were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
Phony Viagra, Cialis Pills Seized by French Customs Officials
Men using Viagra, Cialis and other impotence drugs should be sure to get these from a trusted source. That's because the market - especially the internet, is awash in phony impotence drugs.
In a market worth over $3 million and for the millions of men suffering from erectile dysfunction, the boom of fake Erectile Dysfunction (ED) medications is cause for concern. Another cache of fake medications was recently seized when French customs officials intercepted a shipment of 224,000 counterfeit Viagra and Cialis pills worth 2.4 million euros—$3.5 million—the Budget Ministry said Monday. Copies of the drugs were found on December 18th during a search at the French capital's main air hub at Roissy, in a freight cargo on its way to Brazil from India. "Branded Powergra and Erectalis, each box contained, in fact, four tablets in the characteristic shape and color of Viagra or Cialis pills," Budget Minister Eric Werth's office, which in charge of customs, said. "The companies Pfizer and Eli Lilly, which respectively own the Viagra and Cialis brands, quickly confirmed the counterfeit nature of these products and the 224,000 pills were seized," Werth's office added.Last July, Chinese police seized over a ton of phony drugs including at least 18,000 fake Viagra tablets. Over 30 people were detained on suspicion of either making or selling the drugs. Police in the eastern province of Zhejiang raided the gang making counterfeit Viagra and selling the tablets to 12 countries, including the United States and Holland. In Guangdong, police arrested 12 people and seized one ton of fake drugs, two production lines, and large quantities of raw materials for making "sildenafil citrate," the scientific name for Viagra.
Late last year, Ashish Halai and his group bought counterfeit drugs from Chinese suppliers and sold them to customers who thought they were buying Viagra and Propecia. Their network stretched from Britain to Hong Kong, Dubai, the Bahamas, and the US—to name a few—in Britain’s largest drug counterfeiting case. The fake pills were produced in secret factories in China and Pakistan and smuggled to the US and Europe. Halai and his wife, a pharmacist, ran a legitimate pharmacy for years. When the business was sold, he continued to use the name to sell herbal weight-loss aids. In 2002 he started to deal in counterfeit Viagra, selling via email. He made a deal to supply a Mexican company based in the Bahamas and developed a network of contacts to help him smuggle into Great Britain and ship to the Bahamas. Packages, many of which were shipped with companies such as DHL, were marked as containing vitamin supplements for dogs to avoid detection. The case dates back to 2003 and 2004, when counterfeit batches of the impotence drugs were seized while being smuggled into Heathrow and Stansted airports. Samples revealed the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the Internet; some were sold as prescription medicines. In 2003, the US Food and Drug Administration seized 8,000 packages of Viagra in Miami. In July 2003, Britain’s Medicines and Healthcare Products Regulatory Agency officers seized over 120,000 fake Viagra tablets.
Injured by Viagra?
Viagra Associated with Sudden Hearing Loss
In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug. The Food & Drug Administration (FDA) had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.
Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss. But that is almost always a gradual process, and sudden loss of hearing is rare. According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.
During Viagra’s pre-approval testing, some cases of hearing loss were reported. For that reason, there was a one-word mention of “deafness” as a potential side effect on the old Viagra label. In contrast, the new warning on sudden hearing loss is included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra. It also says that patients should stop taking Viagra and seek immediate medical attention if they experience a sudden loss or decrease in hearing, or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”.
Viagra Vision Loss - Nonarteritic Ischemic Optic Neuropathy (NAION)
In a recent study, US researchers describe seven patients who developed nonarteritic ischemic optic neuropathy (NAION), an eye ailment that can result in permanent vision loss, after taking Viagra (Generic: Sildenafil) for erection difficulties. Combined with past reports, this study brings the total number of sildenafil-related NAION cases to 14. Viagra was approved by the FDA in 1998.
"For years, we've known that a number of men who take Viagra will experience short-term color changes in their vision and see things as green or blue," study co-author Dr. Howard D. Pomeranz, from the University of Minnesota in Minneapolis, said in a statement. With the exception of one patient whose symptoms began 24 to 36 hours after using Viagra, the patients developed symptoms within 24 hours of use. In all patients, the initial symptoms were blurred vision and some degree of vision loss. In one patient, both eyes were affected, whereas in the remainder, just one was involved. Three patients had preexisting eye problems that may have increased their risk of NAION.
Pfizer Inc., the world's largest drugmaker, said U.S. regulators may require a label warning that the Viagra impotence drug has been linked to reports of blindness and vision loss in at least one in a million users. The FDA has 38 reports of the blindness among users of Viagra. Pfizer has been in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness.
If you or a loved one took Viagra and suffered NAION or other side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug. The Food & Drug Administration (FDA) had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.
Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss. But that is almost always a gradual process, and sudden loss of hearing is rare. According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.
During Viagra’s pre-approval testing, some cases of hearing loss were reported. For that reason, there was a one-word mention of “deafness” as a potential side effect on the old Viagra label. In contrast, the new warning on sudden hearing loss is included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra. It also says that patients should stop taking Viagra and seek immediate medical attention if they experience a sudden loss or decrease in hearing, or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”.
Viagra Vision Loss - Nonarteritic Ischemic Optic Neuropathy (NAION)
In a recent study, US researchers describe seven patients who developed nonarteritic ischemic optic neuropathy (NAION), an eye ailment that can result in permanent vision loss, after taking Viagra (Generic: Sildenafil) for erection difficulties. Combined with past reports, this study brings the total number of sildenafil-related NAION cases to 14. Viagra was approved by the FDA in 1998.
"For years, we've known that a number of men who take Viagra will experience short-term color changes in their vision and see things as green or blue," study co-author Dr. Howard D. Pomeranz, from the University of Minnesota in Minneapolis, said in a statement. With the exception of one patient whose symptoms began 24 to 36 hours after using Viagra, the patients developed symptoms within 24 hours of use. In all patients, the initial symptoms were blurred vision and some degree of vision loss. In one patient, both eyes were affected, whereas in the remainder, just one was involved. Three patients had preexisting eye problems that may have increased their risk of NAION.
Pfizer Inc., the world's largest drugmaker, said U.S. regulators may require a label warning that the Viagra impotence drug has been linked to reports of blindness and vision loss in at least one in a million users. The FDA has 38 reports of the blindness among users of Viagra. Pfizer has been in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness.
If you or a loved one took Viagra and suffered NAION or other side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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