U.S. limits use of antibiotic Ketek

Last Updated: 2007-02-12 12:10:21 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. regulators warned on Monday that Sanofi-Aventis SA's antibiotic Ketek should no longer be used to treat patients with sinusitis and bronchitis, saying the controversial drug carries too many risks.

Ketek, also know by its generic name telithromycin, will remain on the market to treat pneumonia, the Food and Drug Administration said.

The FDA also said the drug will now carry a "black box" warning -- the strongest possible -- against its use in patients who have myasthenia gravis, a disease that causes muscle weakness.

The agency's action, which had been anticipated, follows months of debate on the safety of the drug after the FDA began investigating reports of severe liver damage and death in some Ketek patients in January 2006.

In December, an FDA advisory panel recommended more limited use.

Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research, said the agency decided to make the changes "to improve the safe use of Ketek by patients and give health-care providers the most up-to-date prescribing information."

Ketek will also carry stronger warnings about possible side effects such as blurred vision and loss of consciousness, the FDA said. The drug already carries a warning about possible liver damage.

Officials at Sanofi's Paris headquarters had no immediate comment but said they would issue a statement later.

(Additional reporting by Ben Hirschler in London)