Since it hit the market in 2010, the blood-thinning drug Pradaxa has definitely been making waves. According to the New York Times, although Pradaxa has generated more than $2 billion in sales in the U.S. and has been prescribed to 850,000 patients, it has been found to cause fatal bleeding and been linked to more than 1,000 deaths reported through the end of 2012. As a result, the drug’s maker, German company Boehringer Ingelheim, is currently facing more than 2,000 lawsuits in the U.S. Boehringer Ingelheim is standing by the drug, insisting that it is safe according to clinical trials.
Pradaxa is a drug that keeps the platelets in blood from clotting. It is used to prevent blood clots and reduce the risk of stroke in people with a specific type of heart rhythm disorder. But because Pradaxa keeps blood from clotting, it also makes it easier for someone to bleed, even after a minor injury. There is currently no antidote for Pradaxa to reverse its blood thinning effects, so consequently patients who take the drug run the risk of bleeding to death since there is no medical remedy currently available to prevent it.
One of Pradaxa’s main selling points to consumers is that the drug does not require regular blood tests to ensure that it is working properly. But that precise point has been the subject of intense debate among heart and stroke specialists for several reasons:
- Not all people metabolize the drug in the same way
- Few dose options are available
- There are no tests available in the U.S. to monitor those who might be at a higher risk for bleeding
Pradaxa is approved in the U.S. in a 150-milligram dose and a 75-milligram dose for those with low kidney function, but the FDA did not approve a 110-milligram dose because it was believed that the lower dose would not be beneficial to the majority of patients. In Europe, where Pradaxa was approved in 2008, an additional dose and a test are available. Despite the numerous patient bleeding deaths and the absence of an antidote, Pradaxa remains on the market, although the FDA has announced plans to perform a large new safety assessment of the drug.