Source: Lawyers and Settlements
Washington, DC: The new drug application for the antibiotic, Ketek, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1, 2004, based on fraudulent studies, and over the objections of the agency’s own scientists. The approval of Ketek, marketed by Sanofi-Aventis, follows a pattern that has emerged since the Big Pharma friendly Bush administration took control of the FDA where the agency has overruled the findings of its own reviewers.

Doctors and patients alike have a paid a heavy price for trusting the FDA’s approval of Ketek. According to a review by the staff of the Senate Finance Committee, of the Adverse Event Reporting System, between July 2005 and September 2005 alone, there were two deaths, 35 liver adverse reactions, 44 cardiac events, and 80 visual events in Ketek patients. On January 20, 2006, the FDA issued a Public Health Advisory, in response to an article in the Annals of Internal Medicine, that reported 3 cases of severe liver damage in Ketek patients. One died, another required a liver transplant, and a third patient recovered from drug-induced hepatitis after Ketek was stopped. The report also said that Sanofi reported 7 cases of liver damage in patients taking Ketek in Phase III trials.

That said, it took more than year for the FDA to finally ban Ketek for use in two of its 3 approved indications, but the drug is still approved to treat pneumonia. The new labeling warns that cases of acute hepatic failure, including fatal liver injury, have been reported, with some requiring liver transplants, and some occurring after only a few doses. The new labeling also includes a boxed warning that Ketek is contraindicated in patients with myasthenia gravis, and an update about visual disturbances and loss of consciousness, and a warning about reports of diarrhea, ranging in severity from mild to fatal colitis.

The FDA announced its decision to revise Ketek’s label, on February 12, 2007, a day before a hearing was scheduled to review the FDA’s drug approval policies, to include Ketek, before the House Subcommittee on Oversight and Investigation. But the attempt to determine why Ketek was approved in the first place, has been an on-going battle. On November 17, 2006, the Senate Committee on Health, Education, Labor, and Pensions, held a hearing on FDA reform legislation, and the approval process for Ketek was discussed. [more]