E-DRUG: Antibiotic tied to liver damage
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Pfizer Issues Trovan Warning Antibiotic Tied to Liver Damage in Patients
The Associated Press
W A S H I N G T O N, � May 27 � Pfizer warned European doctors Wednesday
that patients taking its popular antibiotic Trovan (trovafloxacin) have
suffered rare but dangerous cases of liver damage. U.S. officials also
are investigating.
A spokeswoman for the U.S. Food and Drug Administration said the reports
of liver damage were serious, and the agency is meeting with Pfizer to
evaluate the risk.
Since February 1998, 140 cases of serious liver damage have been
reported among Trovan users, Pfizer said. Most users recovered after
they stopped taking the antibiotic. But eight patients either died or
required a liver transplant.............
FDA Wants Labels Changed
But because the damage is potentially severe, European officials warned
patients to stop taking the antibiotic if they experience symptoms
suggesting hypersensitivity to Trovan � such as a skin rash or hives �
or such liver symptoms as fatigue, yellowing of the skin or eyes,
stomach pain with nausea or vomiting, or dark urine.
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In the United States, Pfizer is discussing the liver damage cases with
the FDA.....
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