Update from Bloomberg: Pfizer's Trovan Use Should Be Limited, FDA Says (Update1)
Bloomberg News
June 9, 1999, 3:24 p.m. ET
Pfizer's Trovan Use Should Be Limited, FDA Says (Update1)
(Adds comments from Pfizer, details on the FDA advisory,
background on Trovan. Updates share price.)
Washington, June 9 (Bloomberg) -- Pfizer Inc.'s Trovan
antibiotic should only be used to treat patients with serious or
life-threatening illness because of concerns about liver
problems, the U.S. Food and Drug Administration said.
The FDA said the drug's use -- especially in its oral form
-- should be restricted to limited group of patients whose
infections are severe enough to outweigh the risk of liver
damage.
The notice to physicians comes after 14 reported cases of
liver failure in patients taking the drug, the FDA said. Six
patients died and four received liver transplants. Pfizer said it
will work with doctors, pharmacists and wholesalers to limit
distribution of the drug.
''Pfizer believes it is prudent and responsible to
voluntarily limit the use of Trovan to serious patient infections
where Trovan has an important role,'' said Joe Feczko, Pfizer's
senior vice president for worldwide medical operations, in a
statement.
Trovan is an important product for Pfizer, the No. 2 U.S.
drugmaker, and had sales of $160 million in 1998, its first year
on the market after being approved in December 1997.
Pfizer shares fell 5 1/2 to 105 1/2 in afternoon trading.
Feczko said the company didn't believe that there was yet
sufficient evidence of liver problems to merit the FDA's wraning
to doctors, noting that none of 7,000 patients treated with the
drug in clinical trials show evidence of liver problems.
The FDA advised doctors to limit Trovan use to patients who
meet a strict set of criteria. The agency said doctors should
give the drug only to patients who have a serious or life
threatening infection, begin treatment in a hospital or nursing
care facility and start patients on the drug only when the
benefit to the patient outweighs the risk of liver damage.
Label Restrictions
Last month, Pfizer, the U.S.'s No. 2 drugmaker, said Trovan
would get stronger label restrictions in the U.S. and Europe.
Last week, Public Citizen, a citizen's advocacy group, called on
the FDA to withdraw the drug from the market, saying that the
drug ''had no unique benefits and unquestionable unique life-
threatening risks.''
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