Product News and Recalls

Woman dies after switching to Pradaxa

An article in the spring issue of “The Safety Report” gives an account of a woman who died of gastrointestinal hemorrhage after switching to the anti-coagulant Pradaxa.

According to the account, she’d been taking anti-coagulant Coumadin for years because of a heart rhythm problem known as atrial fibrillation. Pradaxa was marketed as a therapeutic simplification that, unlike Coumadin, doesn’t require patients to get monthly blood tests.

Boehringer Ingelheim, the manufacturers of Pradaxa, do not mention any significant risks on the label, the report says. But the FDA is now monitoring patients taking Pradaxa. Since January, more than 500 reports of serious adverse events associated with Pradaxa have come to light.

Patients should consult with their doctors before making any change in medication.