Location: Tulsa, Oklahoma, Tonga

Friday, May 27, 2005

Do you suppose...

Breaking headline story from the New York Times:

F.D.A. Gets Reports of Blindness Tied to Male Impotence Drugs

The F.D.A. said it had received reports of partial vision loss among 38 men taking Viagra and among four men taking Cialis.

The story inside:

Whether the popular drugs can actually cause blindness is unclear, but the Food and Drug Administration said it had suggested changes in the drugs' labeling as a precaution.

Pfizer Inc., the maker of Viagra, is in talks with the agency to list vision loss among the drug's side effects, while the makers of Cialis, Eli Lilly & Company and the Icos Corporation., have already added such a warning.

"We're not able to specifically say that these 38 cases are a result of the patients' taking Viagra, because they may have other predisposing conditions," said Suzanne Trevino, a spokeswoman for the F.D.A.

The type of blindness reported, a disorder known as non-arteritic anterior ischemic optic neuropathy, or NAION, is in fact common among people over 50 who have conditions like diabetes, heart disease, high blood pressure and high cholesterol - factors that also contribute to erectile dysfunction.

"With that said, we are taking this seriously and are working with the company to make sure that doctors and patients are aware of it," Ms. Trevino said.

She said Levitra, which is newer than Viagra and Cialis, had not been linked with any such cases. The drug is made by Bayer A.G. and GlaxoSmithKline P.L.C. and marketed by the Schering-Plough Corporation.

Pfizer, the world's largest drug maker, said in a statement that more than 100 clinical trials, involving 13,000 patients, had found no reports of such vision loss. "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," the company said.

Pharmaceutical news travels fast these days:

This afternoon, Pfizer's shares were trading down 65 cents, or 2.3 percent, to $28.25 on the New York Stock xchange.

Even if clinical trials reported no loss of vision, other sight-related adverse events emerged.

Available since 1998, Viagra has long listed certain vision problems, like "bluish or blurred vision, or being sensitive to light," among its possible side effects, and the 38 cases reported to the F.D.A. represent a tiny fraction of the 23 million people who have taken the drug.

For Pfizer, based in New York, sales of Viagra are supposed to help offset the anticipated loss in revenues from Bextra, a pain reliever, which was pulled off the market last month after being linked to strokes and a rare skin disease. Concerns about the heart-related side effects of Pfizer's drug Celebrex, a similar pain reliever, have also hurt profits.

Blurred vision, blindness... makes you wonder how they are linked to Viagra. Perhaps-- no,no, if that were so, there would be additional reports of hairy palms, too, doncha think?