Panel Urges Caution in Use Of Antibiotic Tied to Deaths
Saturday, December 16, 2006; Page A02
The benefits of an antibiotic linked to rare reports of severe liver problems and several deaths outweigh its risks in treating pneumonia, but it should not be used for less serious bacterial infections such as bronchitis and sinusitis, federal health advisers said yesterday.
The nonbinding recommendations raise the prospect that the Food and Drug Administration could modify its approval of the Sanofi-Aventis SA drug Ketek to exclude the treatment of the two lesser infections, which often clear up without drug treatment.
The FDA convened a two-day meeting of outside experts to discuss Ketek in light of concerns about its safety. An agency review found 13 reports of liver failure in patients treated with the drug through September. Reports of blurry vision also have been a concern. Doctors have prescribed the antibiotic more than 5.6 million times in the United States since the FDA approved it in 2004.
Yesterday, the panel voted 16 to 3 to say Ketek's benefits outweigh its risks in treating pneumonia. The outside advisers voted 17 to 2 that that was not the case for bronchitis and sinusitis.
John K. Jenkins, director of the FDA's office of new drugs, declined to say what action the agency would take. The FDA is not bound to follow the advice of its outside experts but usually does.
The panel also recommended that Sanofi-Aventis develop a medication guide to be given to patients, a move backed by the company.
The acting panel chairman, John E. Edwards Jr., of Harbor-UCLA Medical Center in Torrance, Calif., called the two-day meeting particularly challenging because it came amid concern that companies have diminishing interest in developing new antibiotics and about safety issues linked to the drugs.
The label of the drug was changed in June to add a boldface warning about the rare reports of liver failure, severe injury and death. A majority of panel members said the cautionary language should be strengthened and highlighted in a "black box" to warn doctors and patients of some of the risks linked to the drug.
The FDA's handling of Ketek remains under investigation by a Senate committee. Sen. Charles E. Grassley (R-Iowa) said this week that the FDA intentionally withheld information from FDA advisers when they met in 2003 to consider recommending approval of the drug. FDA officials said they would comment after reviewing his allegations, contained in a 20-page letter sent to the agency.
Sanofi-Aventis said that the risks associated with the drug, also known as telithromycin, appear to be comparable to those of similar drugs and that Ketek represents an important option in treating respiratory infections.