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Warner seeks FDA review
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March 10, 2000: 2:44 p.m. ET
Diabetes drug Rezulin has come under fire for possible liver damage
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NEW YORK (CNNfn) - Drug maker Warner-Lambert Co. asked U.S. regulators Friday to review its diabetes treatment Rezulin, amid allegations that patients are not being properly warned about potential liver damage from the drug.
Last month, CBS News reported that several scientists from the Food and Drug Administration believed that the risks from Rezulin, a treatment for Type 2 adult-onset diabetes, outweigh the benefits, and that key information about the drug's safety was withheld from the FDA. The report cited unnamed sources who said they believed the agency would ask the company to withdraw the drug from the market. Warner-Lambert (WLA: Research, Estimates) denied any such plans.
The Morris Plains, N.J. company, which has agreed to a takeover by Pfizer Inc. (PFE: Research, Estimates), said Friday that while the accusations about the drug's safety were unfounded, "given the serious nature of these allegations, it is imperative that the FDA conduct an objective review of the scientific facts."
Rezulin went on the market in 1997 and was linked early last year to several rare but widely publicized cases of liver failure. The company says the drug is safe when properly prescribed.
Earlier this week, consumer group Public Citizen petitioned the FDA to require stronger health warnings on Rezulin, as well as SmithKline Beecham PLC's (SBH: Research, Estimates) diabetes treatment Avandia and Actos, developed by Takeda Pharmaceuticals and co-marketed with Eli Lilly & Co. (LLY: Research, Estimates). The drugs play down or fail to mention possible liver and heart damage and other side effects, the group said.
Warner-Lambert stock gained 3/4 to 92-1/4 Friday afternoon. 
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Warner-Lambert
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