Pradaxa Internal Bleeding Lawsuit - Consumer Drug Report
Study shows increased heart attack risk with Pradaxa® use

According to a study conducted by the researchers at Cleveland Clinic, Pradaxa use may increase the risk for suffering a heart attack, or symptoms of heart disease by 33%. Researchers Ken Vchino, ivID and Adrian V. Hernandez, MD, PhD reviewed 30,514 patients though out seven clinical trials. The study compared Pradaxa with other similar medications such as warfarin.

Pradaxa (dabigatran) is a blood thinning medication, or anticoagulant, and is included in a class of drugs known as “direct thrombin inhibitors”. Health care professionals typically prescribe the drug to patients with non-valvular atrial fibrillation, a condition in which the heart does not beat properly. Due to this condition, the blood does not flow the way it should causing blood cells to form into clots, or coagulate. These blood clots travel to the brain and cause stroke, or to the lungs and cause pulmonary embolisms. Pradaxa is designed to treat atrial fibrillation by preventing the enzyme which causes blood cells to clot.

The Food and Drug Administration approved Pradaxa in October of 2010. Shortly after the medication was approved, the health regulating agency received numerous reports from consumers who claim to have suffered from side effects of Pradaxa.

Some reported side effects include heart attack, acute coronary syndrome, brain hemorrhaging, gastrointestinal bleeding, internal bleeding, and even death. The FDA has not issued a recall on Pradaxa, however, the agency released a safety communication stating that they are investigating reports of internal bleeding.

Common symptoms of internal bleeding may include bruises with unknown causes, red or black stools, coughing up blood, unexpected bleeding, blood in vomit, and unexpected pain or swelling.

”The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted dose warfarin, [Lovenox®], or placebo," Vchino and Hernandez concludes from the study.

Pradaxa attorneys are currently reviewing cases filed by individuals who suffered severe side effects.


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