FDA requesting advice about Ketek

The Food and Drug Administration (FDA) is seeking outside advice in determining whether or not the antibiotic Ketek should stay on the market, according to an article in the New York Times.

The advice will come from experts on anti-infective drugs who will sit at a public meeting to discuss Ketek. The meetings are scheduled to take place December 14 and 15 and discussion will revolve around the risks and benefits associated with taking Ketek. The panel could recommend further warnings to Ketek's label or some other action to be taken.

Although the FDA does not have to follow the advice of its expert panel, it usually does so.

Ketek, which was approved for use in 2004, has been linked to liver failure in a dozen patients. The drug, known generically as telithromycin and manufactured by Sanofi-Aventis, is used to treat lung and sinus infections caused by bacteria.

The FDA's approval of Ketek and its handling of faulty data are currently under investigation by the Senate Finance Committee. Ketek was actually rejected two times by the FDA because of a lack of safety data before it was finally approved.

Some of the physicians involved in clinical studies of Ketek were investigated for falsifying data, including one doctor who was put in jail for fraud, and another doctor who failed to report any adverse reactions to Ketek. Furthermore, the FDA used data collected overseas when determining that Ketek was safe to use. Rather than using a new study to determine Ketek's safety, the FDA used post-marketing data from Germany and France which may have been skewed due to underreporting of negative reactions to the antibiotic.

By June of 2006, the FDA said that it had received 23 reports of incidents of serious liver injury and 12 incidents of acute liver failure in patients taking Ketek. Of those 12 cases, four people died and one required a liver transplant. At that point, the FDA decided that Ketek warning labels should be updated to include the risk of liver failure.

The FDA reports that in some cases, liver damage occurred quickly and after only a few doses of Ketek. In one case, a 26-year-old died two weeks after taking Ketek for five days. Studies have shown that the rates of liver failure in people taking Ketek are between 3.5 to 11 times higher than with other antibiotics used to treat the same problems.

Signs that there may be problems with taking Ketek include tiredness, aching, lack of appetite, nausea, jaundice, itchy skin, dizziness, blurred or double vision, dark urine, or light-colored stools. If you develop any of these symptoms stop taking Ketek immediately and contact your doctor.