In the second quarter of 2011, a report, submitted to the FDA from the Institute for Safe Medication Practices (ISMP), a nonprofit consumer group, reports Pradaxa (dabigatran) may be responsible for another 117 deaths between April and June 2011.
In the ISMP QuarterWatch report, Pradaxa was associated with 856 reports of injury, disability or death in the second quarter of 2011 including 511 cases of uncontrolled internal bleeding which occurred primarily in users over the age of 80. One quarter of the patients were age 85 or older.
In the first quarter of 2011, there were 931 reports of injury, disability or death. The group concludes that the current one-size-fits-all model of prescribing appears to be particularly deadly to older patients.
The Push for Pradaxa
The blood thinner is made by Boehringer Ingelheim and is promoted as an alternative to warfarin (Coumadin) to be used in patients to prevent heart attack and stroke due to atrial fibrillation, or an irregular heartbeat. It’s promoted as a better alternative because a patient does not have to have their blood checked regularly. However, in a traumatic accident or even a bump on the head that results in bleeding, Coumadin’s anticoagulant properties can be reversed with an injection of Vitamin K while Pradaxa’s blood-thinning properties cannot be reversed.
Pradaxa differs from Coumadin in that it’s a new class of medications called direct thrombin inhibitors, which works on the enzyme that causes the blood to clot.
Warnings are Few
Kudos to physicians for writing in The Journal of Neurosurgery last month about the growing number of deaths occurring among Pradaxa users after even minor accidents such as a fall at home. The label on Pradaxa does not warn there is no effective reversal agent, though the label does say the drug may cause bleeding. That is not sufficient warning for patients or their doctors.
In January a report in the Archives of Internal Medicine, which gathered data from six trials, found Pradaxa users had a 33 percent greater chance of having a heart attack. At the time of these deaths, the drug had been on the market for less than a year. It was approved by the FDA in October 2010, whereas Coumadin has been used in this country for about 60 years.
The FDA says it’s studying the issue, but a serious review cannot come soon enough for Americans looking for answers concerning the dangerous potential side effects of Pradaxa.
Searcy Denney is representing clients in product liability actions alleging that Boehringer Ingelheim did not do due diligence in bringing the drug to the market or to adequately warn consumers and their doctors about the potential for fatal side effects.