FDA Officer: Viagra Reports Kept Under Wraps

Washington, DCMore than 13 months before the Journal of Neuro-Ophthalmology reported that Viagra had been linked to a rare form of blindness, a Food and Drug Administration (FDA) safety officer reported the same findings, based on monitoring the agency's adverse event reporting system.

Yet it was more than a year before the FDA took decisive action. And, while the drug's label currently has warnings about possible side effects involving eyesight, such as increased sensitivity to light and blurred vision, critics say the warnings are still not enough.

Congress: Did FDA Have a Delayed Response?
The FDA officer told congressional investigators that her supervisors that doctors and patients should be warned of the findings, which correlated a form of blindness called nonarteritic anterior ischemic optic neuropathy (NAION) with some men who used Viagra.

She said that her observations were taken seriously by her supervisors. Yet the FDA issued no public notice, and it did not propose changes to the Viagra label until a spate of publicity more than a year later, following the Journal of Neuro-Ophthalmology report.

Congress is currently investigating the drug approvals process at the FDA. Former and current FDA officers, as well as consumer advocates, have given testimony expressing concern over the process. Some critics have suggested that FDA officials have gotten too cozy with drug companies, especially since drug companies support the FDA financially through a fee system.

The safety officer's experience was outlined in a letter to the FDA's Acting Commissioner from Sen. Charles E. Grassley (R-Iowa). "I am troubled by the FDA's action, or lack thereof," Grassley wrote.

According to Grassley, the FDA officer said that the FDA "is under such time pressure to approve new drugs, often safety concerns need to be 'fit in' where they could." 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."

New Findings
A recent report in the Archives of Ophthalmology analyzes scientific claims that Viagra caused men to lose eyesight, as well as reports from patients of intraocular pressure, retinal vascular disease and other eye complications. More than 800 patients and doctors have reported eye problems to the FDA after using the drug.

NAION, a form of sudden blindness, is caused by the blockage of blood flow to the optic nerve and is most common in older men, who disproportionately use Viagra.

Some patients feel reticent to mention their use of the drugs, but physicians advise that all Viagra, Cialis and Levitra users should inform their ophthalmologists about their prescriptions. If you take any of these drugs and have been experiencing difficulties with your eyes, it is recommended that you speak with your ophthalmologist about your concerns.

Post-Marketing Research Falls Flat
It has been less than a decade since Viagra and similar drugs were approved by the FDA. Viagra was approved by the government in 1998. Levitra, which is similarly prescribed, was approved in August 2003, and Cialis, a similar drug, was approved later that year.

Industry critics argue that many drug companies do not perform enough post-marketing research to determine side effects once drugs hit the market. One policy analyst remarked, "There is a rush to approve new drugs, but a bigger problem is lack of follow-through. You can't rush through approvals and then just sit back and have your cigarette. You have to make sure that new users aren't experiencing problems you hadn't anticipated.

"In the case of Viagra, thousands of patients have filed lawsuits. If drug companies had listened to that little voice at the FDA [the officer], perhaps they could have avoided this."