Not long after Roy Heady switched from the blood thinner Coumadin (warfarin) to the newly approved Pradaxa, he suffered a hemorrhage. Now he is one of hundreds of patients suing the drug’s maker claiming the anticoagulant causes serious and sometimes fatal bleeds.
“I thought (Pradaxa) would lessen the headache of being on Coumadin,” Heady told USA Today. “But it ended up creating more of a headache.”
Pradaxa was cleared by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with atrial fibrillation. It became the first anticoagulant in more than 50 years to replace warfarin for the same indication, and its entry onto the drug market was met with much anticipation.
Warfarin effectively prevents strokes in atrial fibrillation patients, but it carries dangerous side effects, including the risk for internal bleeding events. Because there are numerous food and drug interactions that can increase the hemorrhage risk with warfarin, patients on the older drug have to be monitored on a regular basis. It was highly inconvenient to be on the drug.
Pradaxa held promise for both doctors and patients, as it had fewer interactions and was thought to have less risk. The drug’s maker, Boehring Ingelheim, launched a multi-million dollar marketing effort to promote the drug. The investment paid off. In 2011, Pradaxa sales topped $1 billion, earning it blockbuster status.
Where the drug was also growing was in the number of adverse events reported to the FDA. Reports of sometimes fatal hemorrhages earned Pradaxa the top spot in the number of adverse events reported to the FDA among monitored drugs in the year 2011. The news prompted the FDA to order a safety review of the medication, which is ongoing.
Until the FDA reports on its findings, the public must serve as guinea pigs. For people like Heady, that is not good enough. Legal experts say that Pradaxa lawsuits could number into the thousands by next year, potentially making it the country’s next blockbuster civil settlement.
Source: USA Today