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New report criticises Upjohn over Halcion

BMJ 1994; 308 doi: https://doi.org/10.1136/bmj.308.6940.1321a (Published 21 May 1994) Cite this as: BMJ 1994;308:1321
  1. C Dyer

    Upjohn, the maker of the banned sleeping pill Halcion (triazolam), “engaged in an ongoing pattern of misconduct” over the drug, according to a report from the US Food and Drug Administration (FDA) investigators. The company failed to report 30% of adverse side effects in a pivotal early study, protocol 321, the report concludes. Upjohn seemed to have misrepresented data to persuade the FDA to waive a proposed 14 day limit on use, “even though available evidence indicated that long term use was both dangerous and medically untenable…. The firm chose to disregard the potential harm of inappropriate use, in order to gain additional sales (profits).”

    The conclusions come from the report of …

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