Consumers who take the blood thinner Pradaxa should be aware that serious side effects, including uncontrolled bleeding and heart attacks, have been associated with the drug.
Pradaxa (dabigatran etexilate mesylate) is given to patients with atrial fibrillation, or an irregular heart rhythm. It is designed to reduce the risk of stroke. The drug works by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting and causes stroke. The problem with Pradaxa is that it has no antidote.
If you took Pradaxa and suffered uncontrollable or excessive bleeding, heart attack or acute coronary syndrome, contact a prescription error lawyer at Salvi, Schostok & Pritchard P.C., today at our toll-free number or through our online form. We are investigating legal claims related to Pradaxa’s side effects, and we may be able to help you.
The U.S. Food and Drug Administration (FDA) approved Pradaxa in October 2010. The drug has been prescribed to patients with abnormal heart rhythm (atrial fibrillation) to prevent strokes and blood clots. It is not recommended for patients with atrial fibrillation caused by heart valve problems.
Pradaxa is manufactured by Boehringer Ingelheim in capsule form in 75 mg and 150 mg dosages. The drug is most often prescribed to be taken twice a day, with or without food.
From approval in October 2010 through August 2011, about 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies, the FDA said.
Bleeding Risk Associated with Pradaxa
In a clinical comparison of Pradaxa and the anticoagulant warfarin, the FDA noted that patients taking Pradaxa had fewer strokes than patients who took warfarin. By December 2011, however, the FDA said it was reviewing reports of serious bleeding among some Pradaxa users.
In May 2012, the Journal of Neurosurgery reported that an elderly Pradaxa patient died after he fell and hit his head. The patient’s doctors could not stop what began as minor bleeding in his brain, according to the journal article.
In December 2012, the FDA issued a drug safety communication that said Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves. A clinical trial in Europe was halted because Pradaxa users were more likely to experience strokes, heart attacks and the formation of blood clots on the mechanical heart valves than were users of warfarin, the FDA said. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.
Boehringer Ingelheim warns users on its Pradaxa website that “Pradaxa can cause bleeding [that] can be serious and sometimes lead to death.” It advises against taking Pradaxa if you:
- Currently have abnormal bleeding
- Have ever had an allergic reaction to it
- Have had or plan to have a valve in your heart replaced.
The Pradaxa label has similar warnings.
Heart Problems Associated with Pradaxa
Some patients who have taken Pradaxa have suffered heart attack and acute coronary syndrome. Acute coronary syndrome is defined as chest pain or other symptoms caused by a sudden reduction in the flow of blood to the heart.
The Cleveland Clinic analyzed seven clinical trials involving more than 30,500 patients taking Pradaxa or comparable medications. Researchers said Pradaxa patients consistently exhibited a significant increase in their risk for heart attack or acute coronary syndrome when compared with patients who took warfarin or a placebo. The Cleveland Clinic study was published by the Archives of Internal Medicine in January 2012.
Legal Options after a Pradaxa Injury
If you or a loved one of yours has taken Pradaxa and suffered uncontrollable or excessive bleeding, heart attack or acute coronary syndrome, you have the legal right to hold the manufacturer and distributor of the drug accountable. You may be entitled to compensation for your medical expenses and pain and suffering caused by Pradaxa’s adverse side effects.
The lawyers of Salvi, Schostok & Pritchard P.C., are investigating cases of injuries and death attributable to Pradaxa to determine whether there is cause for individual personal injury or wrongful death lawsuits. Allow us to analyze the facts of your particular involvement with Pradaxa and advise you about what legal steps you should take next.
Our firm has obtained more than $1 billion for our clients, including more than 225 multimillion-dollar verdicts and settlements. We may be able to secure a recovery for you as well.
Call us today at our toll-free number or complete our online form. We can provide a free consultation about your case.