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Category: Articles » Health & Fitness » Medicine » Article » Article Code

Ketek Side Effects

The antibiotic drug Ketek is marketed in the United States by Sanofi-Aventis. Approved by the Food and Drug Administration in April 2004 (although it had been rejected three years earlier), Ketek is used for the treatment of adults with serious bacterial infections—such as strep throat, pneumonia, sinus infections and chronic bronchitis. Dr. David Graham of the FDA's Office of Drug Safety opposed its approval, writing in July 2006 that he was "unaware of any unique or life-saving advantage offered by telithromycin [Ketek] that might offset or balance against either an absence of safety data or evidence of unusually high ... read more

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Dr. David Graham of the FDA's Office of Drug Safety opposed its approval, writing in July 2006 that he was "unaware of any unique or life-saving advantage offered by telithromycin [Ketek] that might offset or balance against either an absence of safety data or evidence of unusually high hepatotoxicity."

Ketek has been associated with serious liver injury, liver failure and possibly death. It has proven to have other adverse side effects linked to liver failure including (but not limited to) headache, dizziness, alteration in taste, loss of appetite, nausea, vomiting, constipation, diarrhea, jaundice and hepatitis. Other Ketek side effects are difficulty sleeping, nervousness, double vision, severe muscle pain or weakness, rash, heart palpitations and arrhythmias, and temporary loss of consciousness.

In the U.S. alone, where some 5 million prescriptions have been filled, 14 adult patients have experienced liver failure, and four of them died. Twenty-three other patients have reported serious liver injury. A recent article in the Annals of Internal Medicine showed the serious nature of Ketek side effects. Three patients taking Ketek, all of whom had been healthy, came down with jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died.

Last year was an interesting one for Ketek and its maker. In January, the AIM article was published and the European Medicines Agency asked Sanofi-Aventis to place a stronger warning on the label of Ketek. In May, the FDA called for a black-box warning on the Ketek label due to "severe, life-threatening and in some cases fatal" liver toxicity as Ketek side effects. Senators Charles Grassley and Henry Waxman very publicly asked questions about the agency's handling of Ketek. In June, the FDA warned that just a few doses of Ketek can cause side effects such as liver failure. And in December, two FDA advisory committees said that Ketek should be limited to second-line therapy for people with community-acquired pneumonia.

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