Handelsblatt Exclusive

Authorities Target Bayer Blood Thinner

bayer lab berkeley calif tek image science photo library corbis
A Bayer laboratory in Berkeley, California, and European regulators are investigating whether Bayer used faulty testing equipment in clinical trials that led to the approval of its best-selling blood thinner, Xarelto.
  • Why it matters

    Why it matters

    Bayer’s Xarelto is the second German-made anticoagulant to come under the scrutiny of authorities this week, and Bayer as well as Pradaxa-maker Boehringer Ingelheim might face declining sales.

  • Facts


    • In the clinical trial of Bayer’s Xarelto, a faulty device was allegedly used in clinical trials that led to European and U.S. approval of the blood thinner.
    • European and U.S. authorities are investigating the case. Bayer has denied that it used improper equipment in testing the drug, one of its best sellers.
    • Earlier this week, a German prosecutor said it was investigating allegations that a blood thinner made by Boehringer Ingelheim of Germany called Pradaxa could be unsafe, which the company denies.
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Xarelto, a best-selling anticoagulant made by German drug maker Bayer, is being investigated by the European drug safety agency, Handelsblatt has learned. Xarelto is the second German anticoagulant to come under the scrutiny of European regulators this week.

Medicine to prevent strokes is a lucrative part of the pharmaceutical industry for Bayer, German rival Boehringer Ingelheim and U.S. leader Pfizer, especially since 2011.

The number of prescriptions for the blood thinners has been skyrocketing. Part of the appeal of the new class of medicine is that patients supposedly do not have to submit to regular, costly blood tests to monitor levels of the drug in the body.

Bayer, the maker of Xarelto, and Boehringer Ingelheim, maker of Pradaxa, each generate more than €1 billion ($1.09 billion) annually with their pills.

But both companies’ products are attracting scrutiny.

“We need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” said U.S. Senator Bernie Sanders, a Democrat running for president.

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