FDA warns doctors about antibiotic Trovan

The FDA is also telling physicians that therapy with Trovan should not last longer than 14 days. Patients should discontinue use if any clinical signs of liver dysfunction develop. which include fatigue, loss of appetite, yellowing of the skin and eyes, severe stomach pain with nausea and vomiting. or dark urine.

"Obviously, we need to see the details of all the patients and the adverse events to be able to interpret the importance of these toxicities," said Dr. David Parenti of George Washington University Medical Center. "Given this advisory, I think we'll be less likely to use this compound, considering there are other alternatives available."

The FDA warning said this action is being taken to "reduce the potential risk from Trovan, while at the same time preserving for physicians and patients alike the clincal option of an affective broad spectrum antibiotic for serious and life-threatening infections. The agency considers this advisory an interim measure until revised labeling for the product can be approved."

Dr. Joe Feczko of Pfizer, Trovan's manufacturer, said, "This risk assessment requires additional scientific evaluation and analysis in order to provide physicians with proper clinical guidance to use Trovan safely and effectively. The degree of risk associated with Trovan use is not markedly different when compared with other widely used antibiotics."

According to the FDA, approximately 2.5 million prescriptions have been written for Trovan since its February 1998 approval.

The FDA says it is aware of 14 cases of acute liver failure. Six of those patients have died.