The committee did not recommend the drug be taken off the market, but did urge a “black box” warning for the drug, the strongest warning the FDA can put on a drug’s label. Ketek has been on the market only since 2004, but since then, problems have seemed to follow it.
The drug, used to treat sinusitis and bronchitis, has been linked to over 30 cases of liver failure or severe liver injury.
The F.D.A. first raised questions about liver problems associated with Ketek in 2001, a year after the company first applied for approval. The agency required an additional safety study before it would approve the drug.
That study of 24,000 patients was fraught with problems. A doctor in charge of one study site ended up in jail for fraud, and another lost his medical license.
Then, last spring, Sanofi-Aventis announced a pause in its clinical trials of Ketek to treat ear infections and tonsillitis in children after The New York Times reported on an internal memo written by an F.D.A. official, Dr. Rosemary Johann-Liang, questioning the safety of the drug. Shortly afterward, the F.D.A. warned that Ketek could cause liver problems, noting 110 adverse reports involving the drug, including 12 of liver failure and 23 involving serious liver injury. Ketek was one reason for a long delay in the Senate confirmation hearings of Dr. Andrew C. von Eschenbach as the F.D.A. commissioner, which were postponed after Senator Charles E. Grassley of Iowa accused him of withholding data from the Senate.
Sen. Chuck Grassley said the Food and Drug Administration intentionally withheld key information from its own advisory panel on the drug Ketek in January 2003 about the integrity of a pivotal clinical trial used to support the safety of the drug.