Pradaxa Bleeding Lawsuit
Pradaxa Internal Bleeding
On March 1, 2012, a report published by the New England Journal of Medicine claimed that hemorrhage and other serious consequences of using Pradaxa and similar blood thinners was because of the absence of an effective reversal agent to stop bleeding caused by these drugs. According to a meta-analysis published by the Institute for Safe Medication Practices in January 2012, there was a considerable increase in the number of Pradaxa internal bleeding incidents in the first quarter of 2011. The FDA has received more than 500 Pradaxa hemorrhage complaints through its Adverse Event Reporting System, which is significantly higher than the number of such hemorrhages involving other blood thinners, such as Coumadin and drugs containing warfarin.
FDA Pradaxa Warning
On December 7, 2011, the FDA issued a drug safety communication, stating that it had started investigating all the post-marketing reports of Pradaxa bleeding side effects. In January 2012, after receiving surprisingly high number of adverse event reports, the FDA asked Boehringer Ingelheim to update labels on Pradaxa, warning consumers about the risk of lower blood clotting in the body caused by the drug.
The FDA along with the German pharmaceutical giant Boehringer Ingelheim, the manufacturer of Pradaxa, has started a safety assessment of the side effects of Pradaxa to find out if there is anything unusual about the drug adverse events, which could pose an unreasonable risk to consumers. The study will look into the bleeding deaths reportedly caused by Pradaxa since the release of the blood thinner. The Canadian and European health regulators are investigating into the health risks posed by Pradaxa amid the rising number of post-marketing reports and complaints linking the blood thinner to hemorrhage and death.
In Japan, the manufacturer has been asked to place additional label warnings on the drug, while in many European nations, health practitioners have been advised to test patients’ kidney functions before prescribing Pradaxa in a bid to reduce the risk of bleeding complications.
Pradaxa Internal Bleeding Complaints
In October 2010, Boehringer Ingelheim introduced Pradaxa as a superior alternative to warfarin in the United States, claiming the blood thinner was effective in the prevention of strokes among patients with atrial fibrillations. However, a number of adverse event reports, including hemorrhages, have been reported among patients who took the medication. The blood thinner has also reportedly caused hundreds of deaths. There is no proven way to reverse internal bleeding caused by Pradaxa and its anticoagulant effects.
On March 12, 2012, the Prescription Medicines Code of Practice Authority, a self-regulatory body of the British pharmaceutical industry, alleged that the maker of Pradaxa had violated the code of conduct laid down by the industry by posting wrong information on its website. According to the British agency, the drug manufacturer violated industry norms by making false claims in a press release that referred to Pradaxa as a “wonder drug” while describing warfarin, the competing blood thinner, as a “rat poison.” An unidentified general practitioner was the first to bring this to the notice of the PMCPA. The agency has also alleged that the Pradaxa manufacturer had failed to properly warn about the bleeding side effects of the blood thinner and transgressed the code of practice laid down by the Association of the British Pharmaceutical Industry by using its product website meant for medical professionals for public promotion of the drug.
On February 14th, 2012, a study published in the American College of Cardiology Journal suggested that side effects of Pradaxa could increase the risk of bleeding events more than other blood thinners that it was designed to replace. While testing the use of the blood thinner during radiofrequency ablation of atrial fibrillation on 290 patients, the researchers found that Pradxa posed greater risk of bleeding problems than warfarin. The researchers found that Pradaxa users experienced a higher rate (16%) of bleeding problems and thromboembolic complications, including mini-strokes and strokes, than other blood thinners (6%).
In January 2012, a quarterly drug safety report released by the Institute of Safe Medication Practices disclosed that the number of Pradaxa-induced hemorrhages in patients reportedly outnumbered similar bleeding instances associated with all other drugs monitored by it. According to the ISMP report, 932 serious adverse events involving Pradaxa were reported between January and March 2011, which included 120 deaths and 505 reports of internal bleeding.
A number of researchers have also questioned the validity of Pradaxa’s pre-approval clinical trials, alleging that they were fundamentally flawed and the FDA should not have approved the drug for use. Patients and doctors complain that Pradaxa can sometimes have too much effect on clotting agents, which may lead to hemorrhages.
Pradaxa side effects
The FDA has cautioned consumers to contact their health care provider immediately when they observe any of the following symptoms:
- Frequent nose bleeds
- Unusual bleeding from the gums
- Uncontrolled bleeding
- Unusually heavy menstrual bleeding
- Bruises that worsen over time
- Red or black stool
- Pink or brown urine
- Coughing up blood
- Vomiting blood or blood clots
According to a number of consumer complaints, Pradaxa has resulted in persistent pain in their stomach, which has not subsided despite the discontinuation of the drug intake by them. In January 2012, a meta-analysis of clinical data on Pradaxa published on the website of the American Heart Association Journal linked the anticoagulant to an increased risk of heart attacks.
Within just one year of its introduction on the market, Pradaxa has been blamed for over 360 deaths from hemorrhage, which is more than five times the number earlier reported by the manufacturer. During the first three months alone, the FDA received 307 complaints about Pradaxa side effects, which exceeds the adverse event reports of other blood thinners, such as warfarin.
A number of consumers have filed side effects lawsuits against Boehringer Ingelheim, blaming the drug maker for their suffering. The plaintiffs allege that the drug maker failed to properly research the safety concerns associated with the blood thinner or warn consumers and health practitioners about the risk of potentially life-threatening hemorrhages or gastrointestinal bleeding.
On March 7, 2012, a Pradaxa wrongful death lawsuit was filed against Boehringer Ingelheim in U.S. District Court for the Eastern District of Tennessee by the daughter of a woman, who allegedly died from gastrointestinal bleeding caused by Pradaxa. The plaintiff has claimed that her mother started taking the blood thinner in January 2011 for her atrial fibrillation; however, merely two months later, she had to be hospitalized with gastrointestinal bleeding. The patient died shortly thereafter. The Pradaxa lawsuit blames manufacturer Boehringer Ingelheim for failing to instruct doctors how to handle gastrointestinal bleed events.