The Food and Drug Administration has issued a warning letter to Pfizer Inc. for failing to promptly report serious side effects linked to several of its drugs, including Lipitor, Lyrica and Viagra, according to the Associated Press.
In one instance, Pfizer did not report vision problems involving Viagra, the erectile dysfunction drug, within a 15-day deadline.
A FDA inspection of Pfizer’s New York headquarters last summer prompted the letter. The FDA discovered reports that Pfizer never sent concerning Lipitor and Lyrica’s side effects. Pfizer initially blamed staff who they said were not properly trained to handle a new computerized system, and told the FDA last fall that it would issue better training materials.
Despite this promise, the FDA said that Pfizer’s attempts to rectify the situation had been inadequate. In a statement, Pfizer said it would work with the FDA but that the reports in question are only one part of a larger monitoring process.
According to the FDA, Pfizer’s reporting delays go back to as early as 2004, but have accelerated recently. Between March 2006 and December 2008, 4 percent of their reports were not filed on time, compared with 9 percent between December 2008 and June 2009.
The warning letter gives Pfizer 15 days to submit a plan for correcting the problems.
