Xarelto makers enjoy huge profits despite bleeding risks
Sales of the blood thinner Xarelto have more than quadrupled compared to prior year quarter to $105 million, and were up $88 million in the second quarter, according to Bayer. Xeralto, a joint effort by Bayer and Johnson & Johnson, is used to prevent deep vein thrombosis and pulmonary embolism in patients who are having hip replacement or knee replacement surgery. In late 2011, it became one of the first blood thinners since the long-used warfarin for the prevention of strokes in patients with a common but life threatening heart rhythm abnormality known as atrial fibrillation.
A year before Xeralto was approved for atrial fibrillation, the Food and Drug Administration (FDA) cleared Pradaxa (rivaroxaban) as an alternative to warfarin for the same indication. Warfarin, like all anticoagulants, increases the risk for a major bleeding event. But warfarin has numerous drug and food interactions and patients who use it must be monitored on a regular basis to ensure the drug is working properly. Pradaxa and Xeralto were initially thought to be safer alternatives.
However, in the first 14 months since Pradaxa was approved, the FDA received thousands of adverse event reports associated with the new blood thinner, including 900 cases of gastrointestinal bleeds and 500 cases of bleeding deaths. It is too soon for researchers to gauge the safety of Xeralto.
Unlike warfarin, there is no antidote for either Pradaxa or Xeralto, which means that doctors have few options in saving a person’s life after a major bleeding episode begins. There are reversal agents available for warfarin.
- Lawsuits claim Pradaxa never warned that bleeding side effects may not be reversible
- Pradaxa makers to present blood thinner safety data at Heart Association meeting
- Drug company responds to newspaper’s story about bleeding risks with Pradaxa
- Bayer hopes to expand treatment options for blood thinner Xarelto
- Doctors question safety of new blood thinners Pradaxa, Xarelto