Pradaxa is a drug that is used as a blood thinner. However, since its approval by the FDA in 2010, patients have reported thousands of detrimental effects, including severe bleeding. As a result, several patients filed lawsuits against the manufacturer, Boehringer Ingelheim. While there are many ways in which to remedy extreme bleeding incidents for patients who take warfarin, there is no such cure for Pradaxa.
Some prominent U.S. cardiologists are reluctant to prescribe Pradaxa because of complaints from patients regarding the risks involved as well as fatalities caused by the drug. Pradaxa was initially approved by the FDA in October 2010 for the prevention of strokes in patients who have an irregular heartbeat known as atrial fibrillation. It was the first new oral treatment to be used for that purpose since warfarin came on the market in the 1950s.
According to Dr. Alan Jacobson, director of anti-coagulation services at the Veterans’ Administration (VA) healthcare system in Loma Linda, CA, the usual patient has no comprehension of Pradaxa, its associated risks, or what other medications can or cannot be taken concurrently. For instance, interactions with typical painkillers and other drugs can modify Pradaxa blood levels.
The use of Pradaxa, which does not require blood to be monitored on a regular basis, or doctors to follow up often, is linked to the risk of stroke, severe bleeding and blood clots if it is not taken correctly, especially in patients whose kidneys are functioning poorly. According to the nonprofit institute for Safe Medication Practices, in 2011, there were 542 reports of fatalities linked to Pradaxa that were made known to the FDA.
One published case study featured an elderly patient from Utah whose use of Pradaxa caused the person to suffer a major brain hemorrhage and subsequently die following a minor fall. While regulators from Europe directed Boehringer Ingelheim to include warnings regarding the risk of bleeding to the package insert for Pradaxa, nearly 24 U.S. federal lawsuits were filed against the manufacturer alleging the company of negligence, specifically failure to warn of known risks.
If you were injured due to an unsafe or dangerous medication, call the product liability attorneys at Calcagno & Associates.