Ketek Approval Still Haunting FDA

Rockville MDThe approval of Ketek still haunts the U.S. Food and Drug Administration (FDA), three years after it was first introduced on the market and six years after Sanofi-Aventis first applied for approval to market the antibiotic. Ketek is one of three drugs, the other two being Vioxx and Avandia, that came under scrutiny after being approved because of the serious side effects experienced by patients who took the drug.

In the case of Ketek, the serious side effect was liver failure that occurred in patients taking Ketek at a higher rate than in patients taking other antibiotics. Since Ketek was approved for patient use, 53 patients taking the drug suffered liver failure and at least five have died.

Back in 2006, Dr. David Ross, then an official with the FDA, noticed reports of serious illness and death in patients who took Ketek. Although he met with officials at the FDA and expressed his concerns, the agency took no immediate action. In fact, the FDA did nothing about Ketek until articles about the drug appeared in The Wall Street Journal and The New York Times. Finally, the FDA and Sanofi-Aventis, the maker of Ketek, decided to take action.

However, Dr. Ross and another former FDA official reported that they were told by higher ups in the FDA not to discuss their concerns with outsiders even after the public had learned of the serious adverse reactions to Ketek.

The FDA is not the only guilty party in the tale of Ketek. Sanofi-Aventis allegedly pushed Ketek through the approval process, ignoring serious problems with safety trials even though the company had information that at least one doctor involved in the study falsified patient data. The FDA had this information as well and notified its criminal division. But knowing that safety information was false did not stop the agency from approving the drug. Knowing that one of its doctors faked data did not stop Sanofi-Aventis from submitting its data (with the doctor's data included) to the FDA.