- The Washington Times - Monday, February 12, 2007


The Food and Drug Administration yesterday restricted an antibiotic linked to rare reports of severe liver problems including several deaths, saying the drug should be used only to treat pneumonia and not less-serious illnesses.

The FDA 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 FDA announced the changes on the eve of a House subcommittee hearing on drug safety that will examine irregularities in the approval of Ketek.

FDA spokeswoman Susan Cruzan said yesterday’s announcement was not timed to coincide with the hearing. One member of Congress questioned that.

“It appears that a healthy dose of congressional oversight has reminded them to do their job and ensure the safety of drugs on the market,” said Rep. Edward J. Markey, Massachusetts Democrat.

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 clear up 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.

The FDA’s handling of the antibiotic remains under investigation by the Senate as well.

“The FDA’s action today shows what transparency can do. When a spotlight was turned on the questionable way in which Ketek got approved by the FDA for certain sinus and lung infections, the FDA was held accountable,” said Sen. Charles E. Grassley, Iowa Republican and long a critic of the FDA’s handling of Ketek.

A new so-called “black box” warning on the Ketek label says the drug should not be used in patients with myasthenia gravis, a disease that can cause life-threatening 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 warned 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. The FDA has since learned of one additional such case.

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 and “helps to satisfy a medical need,” Sanofi-Aventis said.

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