The FDA is requiring a warning to be put on Pradaxa to alert health care professionals and the public that the blood thinner, Pradaxa, should not be used in patients with mechanical heart valves. Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than those that used the blood thinner, Warfarin.
The warning came in response to data revealed during a clinical trial in Europe. The trial had to be cancelled due to the increased incidences of heart problems and strokes in patients with mechanical heart valves. This news adds to the growing number of safety investigations and subsequent lawsuits plaguing the manufacturer of Pradaxa.
Pradaxa, manufactured by German drug maker Boehringer Ingelheim, is an anticoagulant prescribed to prevent strokes, blood clots, and atrial fibrillation. It was marketed as the safer, easier alternative to Warfarin. However, the medicine makes it easier to bleed, even from a minor injury. People taking Pradaxa need to be especially careful to avoid activities that may increase their risk of bleeding or injury. Pradaxa is approved to treat patients with a common heart rhythm disorder called atrial fibrillation. It is not approved to treat patients with atrial fibrillation caused by heart valve problems, the FDA said.
Pradaxa is already facing what is expected to be one of the larger mass torts in U.S. history. All anticoagulants have a risk of serious bleeds, but Pradaxa was sold without an antidote. With no antidote, many patients experienced uncontrollable bleeding with no way to effectively treat them. In 2011, the FDA announced that they would be doing an investigation to evaluate the safety of the drug.   Pradaxa was responsible for 3,781 adverse effects and 542 deaths last year, as reported to the FDA. The number of deaths surpassed all other monitored drugs for that year.
The lawyers at D. Miller & Associates continue to take on new clients that have experienced life-threatening bleeding or hemorrhaging while taking Pradaxa.