Company played down drug's risks, report says

BMJ 2001; 322 doi: (Published 24 March 2001) Cite this as: BMJ 2001;322:696
  1. Scott Gottlieb
  1. New York

    Warner-Lambert played down the potentially fatal risks associated with troglitazone during the approval process and received help from federal drug regulators in pushing the drug towards marketing approval, an article published in the Los Angeles Times has claimed.

    The newspaper based its report on company and government documents, some secretly obtained, as well as email communications, which showed that officials from Warner-Lambert had collaborated closely with certain senior officials in the US Food and Drug Administration (FDA) during the approval process and later, when the company was being pressured to take the drug off the market.

    The FDA initially approved troglitazone, marketed as Rezulin, in January 1997 for treatment of type 2 diabetes. The drug was …

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