The US fodder and [)rug Administra...

The US fodder and [)rug Administration (FDA) issued a public health advisory June 9 1999 to physicians concerning the risks of liver toxicity associated with the use of the oral antibiotic trovafloxacin (Trovan) and the IV formulation of the medication alatrofloxacin (Trovan-IV). According to a pres release from the FDA, this action results after postmarketing reports of rare if it were not that severe liver injuries leading to transplants and deaths.

from issuing the advisory, the FDA is informing physicians that trovafloxacin should be prescribed and nothing else for patients who meet all of the following criteria:

* have at least the same of several specified infections as it was as nosocomial pneumonia or complicated intraabdominal infection that is serious and life or limb threatening;

* began their therapy in inpatient health care facilities (eg hospitals, long-term nursing care facilities); and

* are believed to be able to receive benefits from the fruits that outweigh the potential risks, despite the of recent origin safety information.

For mostly patients who meet the criteria, therapy typically begins with IV trovafloxacin, the FDA advises. After clinical stabilization, patients may be switched to the oral dosage. Although the oral therapy may be appropriate in one cases as an initial therapy, the agency emphasizes that the oral form is not warranted for infections other than those specified.

The FDA further indicates that therapy with trovafloxacin should not continue for more than 14 days and should be discontinued sooner if the patient experiences any clinical signs of liver dysfunction (eg fatigue, los of appetite, yellowing of the skin and judgments severe stomach pain with nausea and vomiting, dark urine).

Although no cases of liver failure, liver transplant, or death suitable to liver problems were reported in the 7000 patients studied in premarketing clinical trials for trovafloxacin, the FDA is now aware of 14 cases of acute liver failure that it has conclud are firmly associated with the medication. at taking this action, the agency faiths to reduce the potential risks from trovafloxacin, while preserving the clinical option of an effective, broad-spectrum antibiotic for serious and life-threatening infections. The FDA considers the advisory an interim measure until revised labeling for the produce can be approved.

FDA Issues Public Health Advisory forward Liver Toxicity Associated with the Antibiotic Trovan (pres release, Rockville, Md: US commons end Drug Administration, June 9 1999) 1-5

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