Boehringer Ingelheim GmbH’s anti-coagulant Pradaxa increases a patient’s risk of heart attack or severe chest pain, according to a review of studies conducted on the drug.
An analysis of seven clinical trials found that it was “significantly associated with a higher risk” of heart attacks and acute coronary syndrome, or ACS, a designation that includes heart attacks and chest pain, researchers wrote in a report published today in the Archives of Internal Medicine.
The potential risk of heart attacks could lead doctors to favor Pradaxa’s rivals such as Johnson & Johnson and Bayer AG's blood-thinner Xarelto in a market Leerink Swann analysts estimate to be valued at $9 billion a year.
While Pradaxa appears to prevent patients with erratic heartbeat from having strokes, “clinicians should consider the potential of these serious harmful cardiovascular effects” when prescribing the medicine, said Ken Uchino and Adrian V. Hernandez, both physicians at the Cleveland Clinic in Ohio, in the report.
Of 20,000 patients taking Pradaxa, 237 had a heart attack or chest pain, compared with 83 patients out of 10,514 on the standard drug warfarin or a placebo, Uchino and Hernandez wrote.
The U.S. Food and Drug Administration said last month it would evaluate the Pradaxa studies following reports of serious bleeding events in patients.
Boehringer, based in Ingelheim, Germany, beat New Brunswick, New Jersey-based J&J and Bayer to the atrial fibrillation market. The drugs are vying to become the dominant replacement for warfarin, the half-century old standard of care for preventing blood clots in heart attack victims and other patients. Pfizer and New York-based Bristol-Myers Squibb are seeking approval for their rival pill, known as Eliquis.
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