Pradaxa is a medication that was designed to prevent strokes in patients who suffer from atrial fibrillation, an irregular heartbeat condition common among the elderly. It works by inhibiting the enzyme that is responsible for clotting blood. However, sometimes it works too well. When a patient who is using a drug like Pradaxa suffers a serious bleeding event, their blood fails to clot and can sometimes lead to the patient bleeding to death.
As a result of these side-effects, many Pradaxa lawsuits were and are still being filed. There has been at least one major Pradaxa settlement. More may be on the way.
Pradaxa was first approved for use in the U.S. in October 2010, but it is not purely a domestic issue. The FDA is not the only entity concerned with internal bleeding deaths. European regulators have recommended that patients who are about to start a Pradaxa regimen should first have their kidneys checked. An individual with weakened kidneys has a higher risk of suffering internal bleeding.
Japanese regulators required manufacturer Boehringer Ingelheim to issue a strong warning to physicians regarding the potentially deadly bleeding caused by the use of Pradaxa.
Pradaxa Settlements and History
In May, 2014 the manufacturer Boehringer Ingelheim announced that over 4,000 Pradaxa lawsuits would be settled. Thousands of patients explained that the drug led directly to a life of pain and suffering. Over $650 million was owed the claimants. Despite the massive Pradaxa settlement, the terms exempted the manufacturer from any wrong doing. The company continues to stand behind its drug.
Recent FDA updates have been met with criticism. The FDA has recently announced that following their assessment of the drug, Pradaxa users did not find an increased risk of bleeding in relation to the use of the associated drug, Warfarin. While this information is true, the FDA failed to state that the drug Warfarin includes a reversal agent which would be critical if a bleeding emergency were to occur. Pradaxa, in contrast, does not include an antidote which would be essential for anti-clotting and the stoppage of severe and perhaps fatal bleeds.
Symptoms of Pradaxa Internal Bleeding
Similar to other anti-blood-clotting drugs, Pradaxa’s benefit of reducing the chance of a debilitating or fatal stroke comes with the risk of internal bleeding. If you or a loved one has taken Pradaxa and has experienced any of the following ailments, contact your doctor immediately. If these symptoms are present, you or your loved one might be eligible for a future lawsuit and potential Pradaxa settlement. While nothing is legally guaranteed, please concentrate on your health. See your doctor if you are suffering from these symptoms:
- Unusual bruising or bleeding
- Red or black tarry stools
- Pink or brown urine
- Vomiting that either looks like coffee grounds or resembles blood
- Coughing up blood
- Frequent nosebleeds
- Joint pain or swelling
- Weakness and swelling of the hands feet, arms, ankles or lower legs
Pradaxa Lawsuit Timeline
The Pradaxa lawsuits are always evolving. Class action initiatives take time to develop. Here’s an overview of the medication’s history and the controversy.
July 17, 2017 – Final Results Of Study On Pradaxa Reversal Agent Complete
The final results of the RE-VERSE AD study were released by Boehringer Ingelheim on July 11. The findings were presented at the International Society on Thrombosis and Haemostasis 26th Biennial Congress in Berlin, Germany and simultaneously published in the New England Journal of Medicine. The study results showed that Praxbind was able to completely and successfully reverse the effects of the anticoagulant Pradaxa. The authors reported that there were no serious adverse safety signals related to the reversal agent observed in the study.
June 27, 2017 – Pradaxa Lawsuit Filed By Family Of Deceased Man
A family is suing Boehringer Ingelheim Pharmaceuticals Inc. after the death of their family member, in November 2012, who was using the anticoagulant, Pradaxa, which is manufactured by the company. The family did not partake in the previous $650 million Pradaxa settlement over fatal bleeding risks when taking the blood thinner. The plaintiffs in the wrongful death suit claim that the pharmaceutical company’s widespread discovery misconduct should carry over to this case. The case is scheduled to go to trial this month.
May 26, 2017 – Several Plaintiffs File Pradaxa Lawsuit Alleging Injuries From Side Effects
On April 3, three plaintiffs filed a lawsuit against Boehringer Ingelheim Pharmaceuticals Inc. and several others in the San Francisco County Superior Court. The complaint alleges negligence for failing to warn consumers of the dangerous side effects of uncontrollable and/or excessive bleeding that occur when taking the anticoagulant, Pradaxa. The plaintiffs all claim to have suffered injuries they attribute to their use of the drug.
April 28, 2017 – FDA Grants Tentative Approval Generic Form Of Pradaxa
On Wednesday, April 19, the U.S. Food and Drug Administration granted tentative approval to the drugmaker Glenmark to sell the generic form of the drug Pradaxa. There are currently lawsuits filed against the manufacturers of Pradaxa, Boehringer Ingelheim, for failing to warn consumers of the serious bleeding risks associated with the anticoagulant. Glenmark is attempting to grow their company and has already received 3 other approvals for drugs in the U.S. this year.
April 19, 2016- Industry Payments Under Scrutiny For Not Educating Doctors About New Drugs
A Pro Publica study released in March is providing vital insight into just how much influence industry payments are making on medications doctors prescribe. This industry payment of doctors is believed to influence the prescription of newer drugs like dabigatran that would have little known about rare or longer term harmful effects. In addition drugs like Pradaxa are said to not usually include older people and those with other serious health conditions in pre-market studies. This was the case with Pradaxa, an anticoagulant used to prevent strokes. The drug had no pre-market testing in people over 85, but it was quickly frequently prescribed to this particular age group leading to harmful adverse effects.
Can Victims Still File Pradaxa Lawsuits
Even if you believe you missed the first Pradaxa settlement, there are still victims who experienced potentially fatal internal bleeding issues since 2014. Some believe the new class action may yield even greater success for the plaintiffs and accountability for the manufacturer.