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June 9, 1999 - FDA Issues Public Health Advisory On Liver Toxicity Associated With The Antibiotic Trovan

June 9, 1999 - FDA Issues Public Health Advisory On Liver Toxicity Associated With The Antibiotic Trovan

A public health advisory was issued by the Food and Drug Administration (FDA) to physicians warning them about the risks of liver toxicity associated with the use of Trovan (trovafloxacin, an oral antibiotic) and Trovan-IV (alatrofloxacin, the intravenous formulation of the drug).

FDA is taking this action to reduce the potential risk from Trovan, after reports of rare but severe liver injuries leading to transplants and deaths. But it will preserve for physicians and patients a clinical option of an effective broad-spectrum antibiotic for serious and life- threatening infections. This advisory is a temporary safety measure that will be enforced until the agency can revise labeling for the product. At least 14 cases of acute liver failure that it has concluded are strongly associated with the drug, say FDA officials. Six of these patients died: five of them due to liver failure. Three patients recovered without requiring liver transplants, and for the remaining two patients the final outcome is still pending.

In issuing this advisory, FDA is informing physicians that Trovan should be reserved for use only in patients who meet all of the following criteria:

1) Patients should either have a hospital-acquired pneumonia or a complicated intra-abdominal infection that, in the judgment of the treating physician, is serious or life-threatening,

2) Patients should begin their therapy in an in-patient health care facility like a hospital or a long term nursing care facility, and

3) A the treating physician must believe that even given the new safety information, the benefit of the product outweighs the potential risks.

In addition, Trovan use should not continue for more than 14 days, informed the agency, and the treatment should be stopped sooner if the patient experiences any clinical signs of liver dysfunction, including fatigue, loss of appetite, yellowing of the skin and eyes, severe stomach pain with nausea and vomiting, or dark urine.

For most patients who meet the treatment criteria, therapy should begin with intravenous Trovan and may be switched to the oral dosage form after the patient is stabilized. Although oral therapy might be appropriate in some cases as an initial therapy, the agency emphasizes that the oral form of Trovan is not warranted for infections other than those specified.

The manufacturer agreed to distribute the drug only to hospitals and long-term nursing care facilities and will contact pharmacies to arrange the return of their present inventories of Trovan. Potentially 2.5 million people took this medication since its February 1998 market approval.

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