Pradaxa: Do the risks outweigh the benefits?
Stroke is the third leading cause of death in the United States and the leading cause of long term disability. Pradaxa was approved in October of 2010 in an effort to provide a safer alternative to oral warfarin, injectable low molecular weight heparin or asprin, which was the least effective treatment. Warfarin was the leading therapy, however it carried significant bleeding risks. It also took several weeks to adjust the dose for patients and required monthly blood tests to assure the dosage remained steady. Warfarin also had a number of drug interactions, making it particularly dangerous.
Pradaxa, however, has far fewer drug interactions, though it does have a similar bleeding risk as Warfarin. Pradaxa has a lower incidence of cerebral hemorrhage, but a slightly higher risk of gastrointenstinal bleeding. Pradaxa, however, is significantly more expensive than Warfarin. On the surface, it may appear that Pradaxa is a safe or safer alternative to Warfarin, however, Pradaxa has significant risks as well.
Pradaxa has now been prescribed to millions of patients with atrial fibrillation in over 70 countries in order to prevent blood clots. Unfortunately, thousands of these patients have been injured or killed by uncontrollable bleeding while taking Pradaxa. Although this drug is still being marketed by Boehringer Ingelheim, a federal judge recently ruled that injured patients can file lawsuits against Pradaxa for their injuries.
In December of 2011, the FDA announced a formal investigation into the safety of this drug after receiving 3,781 side effects and 542 deaths in one year, the most of any medication that year. These cases are consolidated into a special federal Multi-District Litigation court in Illinois under MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois. The most significant part of this lawsuit is the failure to warn patients that there is no reversal agent to stop bleeding with Pradaxa as there is with Coumadin or Warfarin. Once Pradaxa causes bleeding, there is little doctors can do to stop it.
In September of 2012, the University of Pecs in Hungary released a study suggesting that the risks of Pradaxa may outweigh the benefits and those taking the drug after an acute heart condition were three times as likely to have a bleeding event. Pradaxa lawsuits are filed individually and not as part of a class action, which is more advantageous to patients. The MDL process is complicated, however, so if you have a claim, ensure you are working with an attorney who has experience fighting large drug companies and working with mass torts.