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Black Box Warning Recommended for Liver-Damaging Antibiotic

Despite the recent efforts of newly appointed FDA Commissioner Dr. Andrew von Eschenbach, an advisory committee for the agency recommended a black box warning for the deadly antibiotic Ketek late last week.

Although the committee found, by a 16-3 vote, that Ketek's hugely debatable benefits outweighed its propensity for making patients more susceptible to pneumonia, they also ruled in favor of a black box warning (13-5) for that same health-harming side effect. If only physicians, pharmacists and patients would pay attention to them...

Also, the committee found Ketek's risks -- liver failure was four times more common than other antibiotics -- outweighed its advantages in treating much milder conditions, namely bronchitis and sinusitis.

Yet, despite glaring reports of the loss of consciousness, liver damage and other side effects, doctors wrote more than 3 million prescriptions for Ketek last year, generating nearly $200 million for Sanofi-Aventis, the mega-drugmaker that brought us the useless sleep-eating medicine Ambien.

iVillage December 15, 2006