FDA Investigating Pradaxa and Serious Internal Bleeding
Pradaxa is the brand name for a blood-thinning medication. The drug is prescribed to reduce the risk of strokes in patients with an irregular heart rhythm.
Bleeding is a recognized complication of anti-coagulant drugs. However, the U.S. Food and Drug Administration has ordered a safety review of Pradaxa. The FDA wants to know whether patients taking Pradaxa have uncontrollable internal bleeding more frequently than would be expected.
The MEDLAW Legal Team of Janet, Jenner & Suggs, LLC, is a nationally recognized law firm investigating injury claims related to Pradaxa. If you suspect that you or a family member has been harmed by Pradaxa, please contact us promptly. Time is of the essence.
News alert: Pradaxa Associated with Higher Risk of Acute Coronary Events
The blood thinning drug Pradaxa has been associated with an increased risk of heart attack, according to a new study in the Archives of Internal Medicine.
In the study, published on Jan. 9, 2012, two Cleveland Clinic researchers found that Pradaxa boosted the risk of a heart attack and an acute coronary syndrome by as much as one-third. The researchers looked at data from nearly 40,000 patients and compared those taking Pradaxa with patients using another blood-thinner or a placebo.
The researchers stated: “The overall benefit and risk balance of dabigatran [Pradaxa] use appears to be favorable in patients with AF [nonvalvular atrial fibrillation] because of reduction in ischemic stroke. However, the cardiac risk of dabigatran should be investigated further, especially if it is used in populations at high risk of MI [myocardial infarction] or ACS [acute coronary syndrome].”
Pradaxa and Reports of Bleeding
Pradaxa is an anti-coagulant drug that reduces the risk of blood clots, which can cause a stroke and lead to permanent disability or death. Pradaxa reduces the risk of a stroke by thinning the blood.
Pradaxa is manufactured by Boehringer Ingelheim, a pharmaceutical company based in Germany. Pradaxa has been on the U.S. market since October 2010.
Pradaxa comes in a capsule. Patients usually take it twice a day, with or without food. From October 2010 to August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed, and about 371,000 patients received the blood thinner.
According to a recent report by Bloomberg news service, Boehringer Ingelheim said Pradaxa has been linked to 250 deaths worldwide. The FDA is working with the drug manufacturer to evaluate post-market reports of bleeding among patients who have taken the drug.
Drug Makers Have Duty to Make Safe Products
Manufacturers of prescription drugs have a legal responsibility to produce drugs that are safe and effective when used as intended. When drug makers fail to meet their legal obligation and consumers are harmed, we believe they should be held accountable.
If you are taking a prescription drug such as Pradaxa, it’s important to recognize the warning signs of complications. It’s also important to understand your legal options if you experience serious side effects.
If You Have Been Harmed by Pradaxa
If you have suffered complications from Pradaxa, including internal bleeding, you may have legal rights to claim compensation. Contact the MEDLAW legal team of Janet, Jenner & Suggs, LLC, today. We offer a free, no obligation consultation.
Let the attorneys of Janet, Jenner & Suggs, LLC help you today
If you or a loved one has suffered serious side effects after taking Pradaxa, you could be entitled to compensation for medical bills, lost wages, pain and suffering and other damages in a defective drug lawsuit against the manufacturer.
We offer a no-obligation consultation. Let us explain how we can help.
Time is of the essence to protect your legal rights. Call 888-463-3529 or contact our drug injury attorneys online.