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6/9/1999

FDA Issues Public Health Advisory on Liver Toxicity Associated with the Antibiotic Trovan

Cheryl A. Thompson

The Food and Drug Administration today issued a public health advisory to physicians concerning 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). This action follows postmarketing reports of rare but severe liver injuries leading to transplants and deaths.

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: 

  • Patients who have at least one of several specified infections such as nosocomial (hospital-acquired) pneumonia or complicated intra-abdominal infections that, in the judgment of the treating physician, is serious and life- or limb-threatening; 
  • Patients who begin their therapy in in-patient health care facilities (hospitals or longterm nursing care facilities); 
  • And patients for whom the treating physician believes that even given the new safety information, the benefit of the product outweighs the potential risks.

FDA is further informing physicians that, in general, therapy with Trovan should not continue for longer than 14 days. Therapy should be discontinued 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 additional information on this Public Health Advisory and Q’s & A’s, visit http://www.fda.gov/medwatch/safety/1999/safety99.htm#trovan2 

For related news story, visit http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY= /www/story/06-09-1999/0000960130&EDATE=