Researchers Claim Pradaxa May Have Been Rushed to Market, Reports Morgan & Morgan

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A new article published in the Journal of American Medical Association claims that the effort to speed approval for Pradaxa may have harmed patient safety, Morgan and Morgan reports.

The attorneys at Morgan & Morgan are alerting Pradaxa users to a new article which indicates that the FDA’s decision to fast-track the blood thinner may have harmed patient safety.

In a Sept. 5 article published in the Journal of the American Medical Association (JAMA), two researchers reviewed the safety records of Pradaxa, as well as two other drugs that received approval under at least one of three FDA expedited programs designed to fast-track certain drugs to the market. According to the article, the safety records of Pradaxa, multiple sclerosis drug Gilenya, and thyroid cancer drug Caprelsa "raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined." The researchers cited the bleeding risk associated with Pradaxa, as well as its lack of an antidote, and said that bleeding in patients taking the blood thinner may be harder to treat than bleeds related to older blood thinner warfarin.

The researchers claim that Pradaxa, used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, went through priority review and the fast track process. According to the FDA, the purpose of the fast-track process is to introduce important, new medications to patients more quickly, while the priority review designation is “given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.” Unlike warfarin, Pradaxa did not require weekly doctor check-ups and dietary restrictions and was touted as the first replacement of the difficult-to-use, decades-old blood thinner, according to an Aug. 19 article in USA Today. Since its introduction into the market, however, Pradaxa has been the center of an FDA safety communication regarding reports of serious bleeding and, in 2011, prompted 3781 adverse events reports - more than all other monitored drugs - to the agency, USA Today reports.

Less than a year after the FDA’s announcement, Pradaxa has become the center of dozens of lawsuits* filed on behalf of patients who suffered serious and fatal hemorrhaging while taking the drug. The suits allege that patients were not properly warned about the drug’s risk of irreversible and fatal bleeds, and that the drug’s lack of an antidote has left healthcare professionals without an effective way to treat and stabilize patients who experience excessive bleeding on the drug. Most recently, a panel of federal judges issued a transfer order centralizing all current and future Pradaxa lawsuits to the Southern District of Illinois before the Honorable David R. Herndon, who has set an initial hearing for Oct. 3.

The Pradaxa lawyers at Morgan & Morgan continue to review claims on behalf of patients who experienced brain hemorrhaging, gastrointestinal bleeding and other forms of internal bleeding while taking the popular blood thinner. To contact the firm for a free case review, please visit today.

  • MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois

About Morgan & Morgan

Morgan & Morgan is one of the largest plaintiff’s law firms in the country and has multiple office locations, including in Florida and New York. The firm handles auto accident cases, personal injury cases, securities lawsuits and medical malpractice cases, as well as claims against drug and medical device manufacturers. Visit Morgan & Morgan online at for a free case evaluation and information about your legal rights.

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Michael Goetz
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