WASHINGTON – The government on Monday restricted use of an antibiotic linked to rare reports of severe liver problems, including several deaths, saying the drug now should be used only to treat pneumonia but not less serious bacterial infections like bronchitis and sinusitis.
The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. The agency said it and manufacturer Sanofi-Aventis SA also created a guide for patients outlining the drug's risks and its safe use.
The changes are in line with the December recommendations of a panel of FDA expert advisers that the agency modify the label of the drug, also called telithromycin. In 17-2 votes, the outside advisers said the drug's benefits don't outweigh its risks in treating bronchitis and sinusitis, which are less serious infections than pneumonia and often spontaneously resolve on their own.
"The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications," the FDA said in a statement.
The FDA announced the changes on the eve of a House subcommittee hearing on drug safety that will examine irregularities in the approval of Ketek. The FDA's handling of the antibiotic remains under investigation by the Senate as well.
A new so-called "black-box" warning on the Ketek label states the drug should not be used in patients with myasthenia gravis, a disease that causes muscle weakness, the FDA said. The label also now warns about cases of visual disturbances and loss of consciousness reported in some patients.
The label already warns of the drug's risk to the liver. An FDA review released in December cited 13 reports of liver failure in patients treated with the drug.
As of late last year, doctors had prescribed the antibiotic more than 5.6 million times in the United States since it won FDA approval in 2004.
"Ketek, when used as directed in its approved indication, continues to be an important option" for fighting infections "helps to satisfy a medical need," Sanofi-Aventis said in a statement.