A new report suggests some doctors are concerned about Pradaxa side effects, which reportedly include an increased risk of death due to bleeding. Concerns have been raised that patients who are given Pradaxa can suffer from uncontrollable bleeding, which puts them at a risk of death even after a relatively minor fall. A case in point involved Loraine Franklin, a Houston resident, who died less than 24 hours after falling on her kitchen floor. Reportedly, she died from an intracranial hemorrhage that could not be stopped. Ms. Franklin had been taking Pradaxa for atrial fibrillation. Unlike with Coumadin, doctors reportedly have no way of stopping the bleeding when Pradaxa patients suffer a traumatic event. This makes something as minor as a fall a life-threatening situation.
It was reported by Reuters in June that some doctors are growing concerned about the risk of bleeding associated with Pradaxa, going so far as to recommend thorough monitoring of patients who are prescribed the medication. Pradaxa was approved by the U.S. Food and Drug Administration in 2010 as an alternative to warfarin in the treatment of atrial fibrillation. According to the Institute for Same Medication Practices, approximately 540 reports involving death linked to Pradaxa were made to the FDA in 2011, with 3,781 serious adverse events in total. That is in comparison with only 72 deaths and 1,106 reports overall linked to warfarin. Although warfarin is linked to an increased risk of brain hemorrhages, it appears doctors are able to stop traumatic bleeding with an antidote when the patient has taken warfarin.
A number of lawsuits have been filed against Boehringer Ingelheim, maker of Pradaxa, alleging that patients died as a result of using the medication and that the drug maker did not adequately warn about the risks associated with Pradaxa. Meanwhile, the European Medicines Agency (EMA) has requested updated warnings to the Pradaxa label, including information on avoiding bleeding risks when using the medication. Although the EMA noted that the drug’s benefits outweighed the risks – and that instances of fatal bleedings were lower than in clinical trials – it stated that more information about the risks should be included on the label. If you need more information contact Roger Smith at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.