FDA officials argue over safety of new arthritis drug

BMJ 2003; 326 doi: (Published 15 March 2003) Cite this as: BMJ 2003;326:565

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  1. Ray Moynihan
  1. Washington, DC

    An external advisory panel to the US Food and Drug Administration last week rejected calls from FDA safety experts to withdraw a drug for rheumatoid arthritis from the market.

    The Arthritis Advisory Committee found that the benefits of the Aventis drug leflunomide (Arava) outweighed its rare side effects, despite an internal FDA report that said that one in 200 users may …

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