Dallas, TX (PRWEB) October 02, 2012
The Pradaxa Resource Center, a patient advocacy group, is alerting patients who took the blood thinner Pradaxa that the drug has been linked to severe internal bleeding. Experts are now cautioning that the FDA may have rushed approval without considering all of the drug’s dangers.
After a recent court decision that those injured may proceed with lawsuits, more than 100 have filed claims. Anyone affected by internal bleeding or the loss of a loved one from Pradaxa is urged to speak with a lawyer about their legal rights as soon as possible.
Pradaxa is a popular blood thinner prescribed to prevent strokes and blood clots in patients with atrial fibrillation. According to an August 27, 2012 report in the Berlin Ad Hoc News, manufacturer Boehringer Ingelheim claims Pradaxa has been prescribed for a combined total of one million patient-years and has been used in more than 70 countries.
On December 7, 2011, however, the FDA warned that it would launch an investigation into Pradaxa after receiving more injury or death reports than expected. The USA Today reported on August 19, 2012 that the agency received 3,781 reports of side effects and 542 deaths among Pradaxa users last year, leading all other medications in 2011.
Now, The Journal for The American Medical Association has warned that the FDA may have rushed approval of Pradaxa. In the September 5, 2012 article “The Safety Risks of Innovation”, authors state the new FDA Expedited Drug Development Pathway may have overlooked key dangers, such as early trials showing Pradaxa had no reversal agent for internal bleeding.
Due to the number of Pradaxa lawsuits expected, a central court was recently established in Illinois to handle the claims. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois. On July 25th, Judge David Herndon issued an order denying attempts by Boehringer Ingelheim to dismiss Pradaxa bleeding lawsuits.
The United States Judicial Panel on Multidistrict Litigation indicated on September 5, 2012 that more than 100 Pradaxa side effect claims have now been filed. Judge Herndon has also set an initial hearing for October 3rd and indicated trials should start in 18 to 24 months.
Anyone affected by internal bleeding after Pradaxa use is urged to speak with a lawyer about their legal options as soon as possible. Due to the specialized nature of these federal MDL cases, the Pradaxa Resource center only recommends lawyers who are already handling Pradaxa lawsuits.