Lawsuit alert: Pfizer and FDA in Talks on Viagra Safety Warnings

Pfizer and FDA in Talks on Viagra Safety Warnings

Pfizer, the world's largest pharmaceuticals group, is in discussions with the US Food and Drug Administration (FDA) about updating the safety warnings for its impotence drug Viagra after rare reports of loss of vision among users.

News of the potential problem with the drug, one of the world's best-known medical brands, helped push Pfizer's share price down by nearly 2 per cent yesterday. One of the compounds in Viagra is manufactured at Pfizer's Cork plant.

The FDA confirmed that it was investigating 38 reports of partial blindness caused by non-arteritic anterior ischemic optic neuropathy (NAION) in Viagra users, but said it had not determined whether the drug was to blame.

The FDA probe comes at a time of heightened sensitivity to drug safety in the wake of a series of health scares including the withdrawal of cox-2 inhibitor anti-inflammatory drugs after concerns about strokes and skin conditions.

Pfizer released a statement saying it was talking to the FDA about updating the Viagra label to reflect these incidents. But it stressed: "There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra."

Pfizer said it had identified 23 cases of NAION-linked blindness or partial blindness. It was aware of one lawsuit, and the link between the ailment and Viagra had been highlighted in the Journal of Neuro-Opthamology in March. It has since been discussing updating information to doctors and users.

It said NAION and erectile dysfunction were common in men over 50 with high blood pressure, high cholesterol and diabetes, making it impossible to determine how far Viagra could be a contributory factor to the condition.
Story from REDNOVA NEWS:

Lawsuit alert: Viagra linked to blindness?

Viagra linked to blindness?

Monday • May 30, 2005

LONDON — An investigation has been launched into the health risks of Viagra, the popular anti-impotence drug, amid concerns that it has caused blindness in up to 50 people.

United States drugs regulators announced that they are examining a number of cases in which users have suffered optic neuropathy — known as "stroke in the eye", reported the Times.

Health officials in Britain said that they too had received reports of six suspected cases of blindness in similar circumstances — when blood flow to the optic nerve is cut off. The condition can lead to irreversible loss of vision.

Since its launch in 1998, Viagra has proved a global sensation. More than 23 million men have admitted to using it, and licensed and illegal trade on the Internet, which allows men to buy the drug anonymously, accounts for tens of millions more sales.

Officials from the US Food and Drug Administration (FDA) announced that they were investigating 42 reports of blindness, 38 among users of Viagra and four among users of Cialis, one of its leading competitors. Non-arteritic anterior ischemic optic neuropathy (Naion) can occur in men who are diabetic or have heart disease — the same conditions that can cause impotence and lead to Viagra use.

An FDA spokeswoman said that the investigation was continuing but that there was no concrete evidence that the drugs were to blame. The FDA is in touch with the manufacturers of Levitra, another drug for erectile dysfunction, in case there is a problem with the entire class of medication. There have been no cases of blindness reported by Levitra users so far.

Pfizer said that it was aware of rare cases of blindness in Viagra users and that the company was in talks with regulators to change warnings on its label. The company also emphasised that no proof existed that blindness was linked to the drug.

Pfizer is facing at least one lawsuit from a user for loss of sight.

Several experts have recently raised concerns about the possibility that Viagra might be linked to Naion. They suggested that all men suffering from the eye condition should be asked if they had taken Viagra.

Pfizer said a review of 103 clinical trials involving 13,000 patients had found no reports of the condition and that reports of loss of vision were "extremely rare".

The Medicines and Healthcare Products Regulatory Agency in Britain said that five of the six British cases, who are all over the age of 50, had concurrent illnesses that may have contributed to their blindness. Pfizer advises that possible side effects of Viagra include "bluish or blurred vision, or being sensitive to light" which "may occur for a short time".

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