Stop The Bleeding: FDA Probes Pradaxa Deaths

Stop The Bleeding: FDA Probes Pradaxa Deaths

December 8th, 2011 // 3:11 pm @

Less than a month after European regulators asked doctors to exercise caution about using the Pradaxa bloodthinner, the FDA has decided to investigate post-marketing reports of serious bleeding patients. As of November 6, the European Medicines Agency was aware of 256 cases of serious bleeding that results in patient deaths associated with the Boeheringer Ingelheim bloodthinner (see this).

In announcing its review, the FDA notes that the Pradaxa labeling already contains a warning about significant and sometimes fatal bleeds. And a large clinical trial of roughly 18,000 patients that compared Pradaxa and warfarin, which has been the standard therapy for decades, major bleeding events occurred at similar rates.

Nonetheless, the reports of deaths have been causing concern for months. A recent report by the Institute for Safe Medicine Practices found that Pradaxa generated a large number of adverse event reports to the FDA (read this). And a flap erupted in New Zealand, where the government has been criticized for agreeing to provide reimbursement too quickly (read here).

Pradaxa, which was approved for preventing stroke in patients with atrial fibrillation, is one of a new batch of bloodthinners that has generated enormous industry from the medical community and investors. Boehringer Ingelheim has been heavily promoting the drug, which was the first be approved, in hopes of capturing as much market share as possible.

However, a forthcoming entrant called Eliquis from Pfizer and Bristol-Myers Squibb is expected to dominate (read here). The other new drug is Xarelto, which is from Bayer and Johnson & Johnson, and was recently approved by the FDA, although given a Black Box warning.


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