In response to reports linking the quinolone antibiotic Trovan to liver toxicity, the Food and Drug Administration has issued a public health advisory to physicians that restricts the use of the drug.
On June 9, the FDA said that Pfizer's Trovan (trovafloxacin) should be reserved for use only in patients who meet three criteria: they have one of several specified infections; they begin their therapy during in-patient care; and their doctors have determined that the benefits of the drug outweigh the potential risk. In general, Trovan should not be used for more than two weeks, and therapy should be discontinued if the patient experiences any clinical signs of liver dysfunction, the FDA said.
Pfizer has agreed to limit distribution of Trovan to hospitals and long-term nursing care facilities.
The FDA issued the health advisory following postmarketing reports of liver injuries that led to deaths and to the need for liver transplants. No reports of liver failure, liver transplant, or death due to liver problems were reported in the 7,000 patients who were studied in premarketing clinical trials for Trovan. However, the FDA said it is now aware of 14 cases of acute liver failure strongly associated with use of the drug. Six of the patients died, three survived after receiving a liver transplant, three recovered without needing a transplant, and the outcome for the remaining two patients is undetermined, the FDA said.
Trovan was introduced in the United States in February 1998.
Pfizer issued a statement on June 9 saying that the company has "a difference of opinion with the [FDA] over the interpretation of these data and the regulatory action being taken." However, the company plans "to work collaboratively with the FDA to ensure Trovan's appropriate use."
For Your Information:
FDA Center for Drug Evaluation and Research
the FDA's health advisory, a talk paper, and questions and answers about Trovan
http://www.fda.gov/cder/news/trovan/default.htmPfizer
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Adverse events associated with Trovan can be reported to MedWatch, the FDA's adverse event reporting system, by mail, phone, fax, or the Internet:
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