Adderall XR linked to deaths, strokes

By Dualpower · Feb 10, 2005 · ·
  1. Dualpower
    ADD drug yanked from shelves</font>

    Adderall XR linked to deaths, strokes</font>


    regulators ordered a drug for attention deficit hyperactivity disorder
    pulled off the market because of reports that it has been linked to 20
    sudden deaths and a dozen strokes, including some among children.

    Health Canada said late Wednesday that it is asking makers of related
    stimulants used to treat the commonly diagnosed condition to provide a
    thorough review of their worldwide safety data.

    None of the
    deaths or strokes associated with Adderall XR, made by Basingstoke,
    England-based Shire Pharmaceuticals Group PLC, were reported in Canada,
    department spokesperson Ryan Baker said.

    "However, Health Canada
    has received eight reports of adverse reactions ranging in severity
    from convulsions to minor skin rash," Baker said. "It's not been
    determined yet whether these reactions were a result of Adderall XR

    Of the 20 cases of sudden death linked to the drug, 14
    were in children. Two of the 12 strokes were suffered by children
    taking the drug. The adverse reactions were not associated with
    overdose, misuse or abuse of the drug, the department said.

    Shire shares fell 10.5 percent to 574.5 pence in trading on the London Stock Exchange.

    The drug is sold in Canada and the United States. A related
    immediate-release form of the drug, sold simply as Adderall, is sold in
    the United States but has not been approved for sale in Canada, where
    11,000 patients are prescribed Adderall XR. Canadian officials approved
    that drug in January 2004.

    Shire's chief executive, Matthew
    Emmens, said in a statement late Wednesday that the company "remains
    confident in the safety and efficacy" of the drug.

    The U.S. Food
    and Drug Administration said it had evaluated the same reports as
    Canadian regulators and doesn't believe the data warranted such action
    in the United States.

    Emmens said the FDA reviewed the same data
    as Health Canada last year and sought an additional warning in
    September that the drug should not be prescribed for people with
    "structural cardiovascular abnormalities.''

    About 700,000 people
    take Adderall XR in the United States, with about 300,000 more using
    Adderall, Shire spokesperson Matthew Cabrey said. Shire reported $140
    million in U.S. sales of the drugs in the third quarter of 2004.

    In a statement posted on its website late Wednesday, the FDA said it
    "does not feel that any immediate changes are warranted in the FDA
    labelling or approved use of this drug based upon its preliminary
    understanding of Health Canada's analyses of adverse event reports and
    FDA's own knowledge and assessment of the reports received by the

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  1. elbow
    I just heard about this on the radio and now they are saying that there
    was possibly an FDA cover-up because they didn't want yet another
    scandal following the recent revelations about Vioxx and other
    painkillers.Sorry I don't have a direct source...I'll try to dig one up.
  2. Lacognac69
    Ya, it very well could be a cover up. The drug companies defniitely don't want it off the market if its making 140 million dollars a quarter. This once again shows how stupid our drug laws really are. That amount of deaths would most likely be enough to make any drug illegal if it wasn't in prescription form.
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