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FDA warns about Pfizer drug
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June 9, 1999: 4:00 p.m. ET
Agency finds Trovan linked to liver problems; drug firm advises limited use
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NEW YORK (CNNfn) - The U.S. Food and Drug Administration said Wednesday it is warning doctors about possible liver toxicity in patients who use Pfizer Inc.'s antibiotic Trovan.
"The FDA is issuing a health advisory on Trovan," an FDA spokeswoman said, adding that the advisory warned doctors that some patients taking Trovan had experienced liver problems.
Shares of Pfizer (PFE) fell on the news, down 4-15/16 at 106-1/16 in late afternoon trade on the New York Stock Exchange.
The FDA spokeswoman said post-marketing reports found "rare but serious liver injuries leading to transplant and death" in some patients taking Trovan.
The European Union agency that monitors prescription drugs reported last month that five patients taking the drug died from liver failure and three required liver transplants.
A U.S. consumer group has called on the FDA to ban Trovan, but the FDA spokeswoman said the agency still believes the drug's benefits outweigh its risks and it should remain on the market.
The FDA approved Trovan in 1997 to kill infections. It was introduced into the market in February 1998, and since then an estimated 2.5 million prescriptions have been written worldwide.
Pfizer recommends limited use
Pfizer Inc. said Wednesday it will notify prescribing physicians to limit the use of Trovan tablets and intravenous formulation to the treatment of certain serious infections.
The pharmaceutical maker said it has received reports of 140 Trovan-related cases of liver problems worldwide from February 1998 through early May 1999, and has submitted them to regulatory authorities.
But, the company said, "data derived from these reports cannot be used exclusively to draw conclusions about a product's risk-benefit profile."
Pfizer said it is continuing to collect medical information and conduct further analysis of the reports and will continue to work collaboratively with the FDA.
"While these analyses continue, Pfizer believes it prudent and responsible to voluntarily limit the use of Trovan to serious in-patient infections where Trovan has an important role," said Joe Feczko, M.D., Pfizer's senior vice president of worldwide medical operations and regulatory affairs. 
-- from staff and wire reports
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