Use of the anti-coagulant Pradaxa may significantly increase the risk of serious and potentially fatal bleeding. In 2011, Pradaxa was associated with at least 3,781 injuries and 542 deaths in the U.S. alone.
What is Pradaxa?
Pradaxa is an anti-coagulant, or blood thinner, prescribed to lower the risk of stroke in patients with atrial fibrillation. Almost immediately after entering the market, Pradaxa became associated with serious and life-threatening injuries, including uncontrollable bleeding of the:
- Gastrointestinal (GI) system
- Heart attack/cardiac injury
Reversal Agents Ineffective with Pradaxa
Manufactured by Boehringer Ingelheim GmbH, Pradaxa was the first drug to compete with long-running blood thinner warfarin. Although the two drugs accomplish the same purpose, one key difference between them has proven to be significantly detrimental to Pradaxa users: Pradaxa bleeding has no antidote.
If a warfarin user begins to bleed uncontrollably, a reversal agent can be administered to slow or stop the bleeding. If a Pradaxa patient begins bleeding, there is often no way to stop it. People taking Pradaxa face potentially fatal bleeding in many situations, such as:
- Uncontrollable bleeding due to a medical condition, such as an ulcer
- Inability to receive life-saving surgery due to bleeding risks
- Bodily trauma, such as that resulting from a car accident
- Spontaneous brain, kidney or gastrointestinal (GI) bleeding
Pradaxa: Dangerous from the Start
Within a month of its October 2010 approval date, Pradaxa was linked to more adverse events than 98 percent of the drugs monitored by the FDA, reported MedWatch. A few months later, the FDA had received 120 reports of death among Pradaxa users.
In January 2012, the Archives of Internal Medicine published a study showing that Pradaxa use leads to a 33 percent increased risk of heart attack. Researchers at the Cleveland Clinic evaluated data from more than 30,000 patients and compared Pradaxa to warfarin-based drugs. They found Pradaxa was more likely to cause heart attack.
April 2012 brought an announcement by the European Medicines Agency (EMA). The EMA reviewed Pradaxa and, in response to serious injuries associated with the drug, required Boehringer to provide doctors with clearer guidance for managing Pradaxa risks.
In May 2012, QuarterWatch, a nonprofit organization that monitors FDA reports, announced that Pradaxa was tied for first place among drugs linked to adverse events. In 2011, Pradaxa use was associated with 3,781 injuries and 542 deaths in the U.S., and was considered the highest risk of all prescription drugs for the year. Pradaxa surpassed all other drugs for reported hemorrhage, acute kidney failure and stroke injuries.
Manufacturer Negligence to Blame
Boehringer Ingelheim GmbH should have thoroughly tested Pradaxa in order to warn users of all possible risks. Instead, Boehringer failed to warn patients, doctors and the FDA of the serious bleeding risks and potential for heart attack associated with Pradaxa. Critics allege that Boehringer rushed the testing of Pradaxa in order to market it before competing drugs. Pradaxa was indeed the first to the market — perhaps at the cost of users’ safety.
Boehringer’s negligence is completely unacceptable. Pradaxa users who have been injured or the family of Pradaxa who have died deserve compensation for hospital bills, lost income, costs of future treatment or funeral services, and physical and emotional damage.
If you have suffered uncontrollable bleeding, or if your loved one lost his or her life due to bleeding after taking Pradaxa, we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.