Boehringer Ingelheim GmbH’s blood thinner Pradaxa has won the recommendation from the United Kingdom’s medical-cost regulator as a treatment to prevent strokes in patients with a life threatening type of irregular heartbeat. The recommendation was made in spite of concerns that the drug may increase the risk of fatal bleeding episodes.
Pradaxa, which comes in tablet form, offers an alternative to warfarin, which has been on the market for nearly 50 years. Unlike warfarin, Pradaxa does not require frequent blood tests to monitor treatment. UK’s National Institute for Health and Clinical Excellence (NICE) said its recommendation is based on trials that showed the drug performing better than warfarin in reducing the risk of stroke or systemic embolism.
Like warfarin, however, Pradaxa carries a risk for bleeding. But unlike warfarin, there is no antidote for Pradaxa. When bleeding events occur, doctors are virtually helpless. Since the blood thinner was approved by the United States Food and Drug Administration (FDA) in 2010, 260 bleeding deaths have occurred in people while using the drug.
A study recently published in the Journal of Neurosurgery confirmed that bleeding complications from Pradaxa are largely irreversible. The FDA is now investigating bleeding events associated with Pradaxa, and some groups are calling for a recall.
Advisory panels make recommendations to federal regulators about whether or not a drug should be marketed in a particular country. Regulators are typically not required to follow the advice of the advisory panel, but they usually do. There is no word yet when Pradaxa might be available in the UK.