Authored by Gloria Mayer
The FDA approved this drug in 2010, and within six months patients were reporting serious bleeding events associated with Pradaxa. In December 2011, the FDA announced a formal investigation into the safety of the drug, after reportedly receiving reports of 3,781 side effects and 542 deaths among users. This was the most of any medication in 2011.
The adverse events associated with Pradaxa include internal bleeding in the brain, intestines and kidneys, as well as heart attacks.
Although all blood thinning drugs can cause internal bleeding, the maker of Pradaxa faces liability because they did not warn patients that there is no reversal agent to stop bleeding as there is with other drugs like Coumadin or Warfarin.
And yet, according to an August 27, 2012 report in the Berlin Ad Hoc News, manufacturer Boehringer Ingelheim claims Pradaxa has been prescribed in more than 70 countries.
If you or a loved one suffered internal bleeding while taking Pradaxa, you may be entitled to substantial compensation. Contact us today to speak with a lawyer about a Pradaxa lawsuit and whether your case qualifies.
The FDA has not recalled Pradaxa, so it is still on the market. Experts fear that many more injuries or deaths will be caused by this drug. The top public health and medical organizations have published their warnings. The European Medicines Agency, The Journal for the American Medical Association, and others have issued warnings on internal bleeding risks.
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.
However, in November 2012, the FDA updated its warnings to say that, for now, testing shows Pradaxa carries the same risks as warfarin and Coumadin. There is no evidence the FDA will recall this drug. Experts are concerned that many patients are taking Pradaxa without knowing the risks.
A federal judge recently ruled that those injured can file a Pradaxa lawsuit for their loss. Due to the number of expected claims, the cases have been consolidated to a special federal Multi-District Litigation court in Illinois. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.
If you have been affected by these serious Pradaxa side effects, it is your right to seek compensation. Lawyers are currently helping victims file claims against the drug company. A Pradaxa lawsuit can be filed individually, instead of as one class action suit. For victims, this is often advantageous.
In choosing an attorney, keep in mind that the federal MDL process can be a complex and highly specialized place of litigation. Make sure your lawyer has experience fighting large drug companies.
The DrugRisks Resource Center works solely with law firms that specialize in defective drug claims and have handled Pradaxa lawsuits.
For more information on the side effects, warnings and legal action related to the drug Pradaxa, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.