ISMP Report Raises More Pradaxa Safety Concerns

Within just a few weeks of its U.S. approval in October 2010, <"">Pradaxa was being named in more Food & Drug Administration (FDA) Adverse Event Reports than any other medication. According to the Institute for Safe Medication Practices (ISMP), in that short time, Pradaxa was named in more FDA side effect reports than over 98% of the medications the group monitors.

Pradaxa, manufactured by Boehringer Ingelheim was approved by the FDA to prevent strokes in people with atrial fibrillation. However, the ISMP found that Pradaxa is already being used off-label extensively, as only a third of prescriptions written since its approval have been for the FDA-approved indication.

According to the ISMP, within 12 weeks of initial marketing approval, Pradaxa was the suspect drug in 307 reported serious adverse events reported to the FDA. It outpaced most other drugs, including warfarin, the blood thinner Pradaxa was meant to replace. Most of the adverse event reports involved serious bleeding or blood clots in the elderly.

This isn’t the first time Pradaxa has inspired safety concerns. In August, regulators in Japan – where the drug is sold as Prazaxa – told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 of the almost 64,000 mainly elderly patients taking it there suffered heavy bleeding. According to Reuters, five of those patients died

In New Zealand, 122 cases of side effects in Pradaxa patients have been reported to the Centre for Adverse Reactions Monitoring (CARM), of which two out of five involved bleeding. As of a month ago, CARM had been alerted to four deaths; however, it said none were caused by Pradaxa. A CARM official said the agency was aware of nine cases of avoidable bleeding that may have stemmed from a too-rapid introduction of Pradaxa following warfarin treatment, or because the victims had inadequate kidney function.

Pradaxa and two similar new blood thinners are considered to be an improvement over warfarin because they do not interact with certain foods like that medication does. However, there is no antidote for Pradaxa bleeding, while bleeding side effects from warfarin can be stopped by the administration of vitamin K.

This entry was posted in Pharmaceuticals, Pradaxa. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.