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FDA Panels Urge Restricted Ketek Use

Dec 16, 2006 | A pair of federal advisory committees has recommended against two of three existing uses for Ketek, an antibiotic from Sanofi-Aventis.

The advisors say Ketek, approved by the Food and Drug Administration in April 2004, should be discontinued as a treatment for acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis. Committee members voted 17 to 2 late Friday afternoon against these uses, saying the risks outweigh the benefits.

However, they said Ketek should continue to be used as a treatment for community-acquired pneumonia, a common lung inflammation contracted by patients who aren't hospitalized or in extended-care facilities. The vote was 16 to 3 in favor of this use.

Many of the medical advisors also recommended that Ketek should receive a "black box" warning of some side effects. A black box warning is the most strict notice the FDA can order for a drug's label. Such a warning can depress a drug's sales because doctors are more cautious about prescribing the drug and patients are more cautious about taking it.

The FDA isn't required to follow its advisory panels' suggestions, but it usually agrees.

The panels' votes ended two days of hearings for a drug whose controversy overshadows its U.S. sales. Ketek's approval by the FDA also is the subject of a Senate Finance Committee investigation of the agency's review process. Ketek produced about $50 million in U.S. sales during the first half of 2006.

"Sanofi-Aventis will be in further discussion with the FDA regarding [the panels'] recommendations," said Dr. Doug Greene, chief medical officer for the company's U.S. operations, in a prepared statement Friday evening. "We are committed to working to ensure that healthcare professionals continue to have the information they need to address the medical needs of their patients."

The company said Ketek has been used to treat more than 6 million patients in the U.S. and more than 28 million patients worldwide. The drug is approved in more than 90 countries, but reports of side effects have depressed sales in the U.S.

Although there have been instances of liver damage, rare neuromuscular problems, blurred vision and several deaths among Ketek patients, an FDA staff report on Wednesday said the drug's benefits outweigh the risks.

However, the report also said the side effects detected after Ketek reached the market and the way clinical trials were conducted raised questions about the drug's use for sinusitis and bronchitis, which, it says, "are often self-resolving conditions."

Sanofi-Aventis strengthened the drug's label in June to further highlight the risks of side effects. The company has maintained that the benefits outweigh the risks for each of the drug's FDA-approved uses, adding that the rate of liver problems is similar to rates for several competing antibiotics.

In June, the FDA said "the benefit/risk profile for Ketek is similar to that of other approved antibiotic drugs used to treat the same types of infections." Liver problems are a "known and potential complication with some antibiotics, including Ketek," the FDA said.

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