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Viagra blindness risk emerges

Pfizer is in discussions with the US Food and Drug Administration about altering its safety warnings on Viagra.

Pfizer is in discussions with the US Food and Drug Administration (FDA) about altering its safety warnings on Viagra after reports linked the famous impotence treatment with partial blindness in some users.

So far the FDA has received 38 reports of sudden blindness among men who took Viagra, although the agency said it had not yet determined whether the pill was to blame.

The latest concern involves a type of blindness, referred to as non-arteric ischemic optic neuropathy (NAION), which usually affects men over the age of 50. It is caused by an interruption of blood flow to the nerve that links the eye to the brain.

In March, a report in the Journal of Neuro-Ophthalmology for eye specialists described seven cases of permanent blindness linked to Viagra.

Lead author of the report, ophthalmologist Dr Howard Pomeranz, said the drug may alter the circulation of blood to the optic nerve and that patients concerned about the risk could get an eye exam to determine if the optic nerve is already narrow.

ìI think the [FDA] investigation is worthwhile,î he said. ìPatients taking the drugs owe themselves a visit to their eye doctor for possible risk.

Pfizer has defended Viagra, saying it is safe. ìThere is no evidence showing that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take Viagra,î the company said in a statement.

Class-action lawyers specialising in suing companies on behalf of patients are now consulting their own ophthalmic specialists to see whether a suit can be built against Pfizer. Viagra's current label already warns of rare side effects, such as eyes being more sensitive to light, blurred vision and temporary changes in colour vision.

Viagra is not the only impotence treatment to be linked with blindness. The FDA has also reported four eyesight-problem cases linked to Lilly's Cialis and one case to Levitra, marketed by Bayer, GlaxoSmithKline and Schering-Plough.

Earlier this month, Lilly ICOS, a joint venture between Lilly and Icos, revised the label for Cialis to include information about reports of serious visual impairment.

During the first quarter of 2005, sales and prescriptions of impotence drugs such as Viagra and Cialis grew by just one per cent in the US despite manufacturers spending $382m on advertising last year.

30th September 2008

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