According to a new report on Pradaxa side effects submitted to the FDA, the controversial blood thinner Pradaxa may be linked to another 117 deaths during the second quarter of 2011. The quarterly report recently issued by the Institute for Safe Medication Practices (ISMP) includes adverse event reports submitted by consumers and healthcare professionals across the country between April and June 2011. According to the ISMP, Pradaxa was linked to 856 reports of serious, disabling or fatal injury in the second quarter of 2011, including 117 deaths and 511 cases of internal bleeding. Most of the reported hemorrhages involved patients over the age of 80, supporting fears about the risk of Pradaxa overdose among older patients, since the drug comes in only one dose.
BLOOD THINNER PRADAXA LINKED TO BLEEDING AND DEATH
Pradaxa (dabigatran) is an anticoagulant manufactured by drug firm Boehringer Ingelheim, and was on the market for less than a year before concerns about the drug’s safety began to plague drug regulators. When Pradaxa garnered FDA approval in October 2010, the medication was celebrated as a superior alternative to warfarin, which had already been on the market for nearly 60 years. Pradaxa is a blood thinner that belongs to a class of medications called direct thrombin inhibitors, meaning it interferes with the enzyme that allows the blood to clot. Doctors across the country prescribe Pradaxa to patients with atrial fibrillation, a serious medical condition in which a part of the heart doesn’t beat properly.
NO TREATMENT AVAILABLE FOR PRADAXA OVERDOSE
The reason that Pradaxa was promoted as a superior alternative to warfarin is because the drug requires less monitoring. Unfortunately, while warfarin users who suffer internal bleeding side effects can be treated with Vitamin K to counter the blood-thinning effects, there is currently no reversal agent for Pradaxa and other drugs in its class. Despite the fact that many doctors have prescribed Pradaxa to patients because it requires less follow-up visits to monitor blood levels, emergency room doctors have expressed concerns about their inability to treat Pradaxa overdose, hemorrhage or bleeding side effects.
PRADAXA LAWSUITS ON THE RISE IN THE U.S.
Concerns about Pradaxa deaths and Pradaxa internal bleeding side effects have prompted safety investigations in the United States, Canada and Europe. An increasing number of patients are now pursuing Pradaxa lawsuits, alleging that the drug firm failed to sufficiently research the medication or warn consumers about the potentially fatal side effects associated with the drug. Today, Pradaxa has been associated with more reported cases of side effects than any other regularly monitored drug.