Pradaxa Overdoses, Hemorrhages Continue Among Older Patients: Report

The controversial blood thinner Pradaxa may have been responsible for another 117 deaths during the second quarter of 2011, according to a new report on problems submitted to the FDA.

The Institute for Safe Medication Practices (ISMP) released their quarterly report (PDF) earlier this week on adverse event reports submitted by consumers and healthcare provides throughout the United States between April and June 2011.

Pradaxa (dabigatran) holds the dubious title of being associated with more reported cases than any other regularly monitored drug, even though the anticoagulant had been on the market for less than a year at the time.

According to the ISMP, Pradaxa was associated with 856 reports of serious, disabling or fatal injury in the second quarter of 2011, including 117 patient deaths on Pradaxa and 511 cases of Pradaxa bleeding events.

Most of the reported hemorrhages involved patients over 80 years old, reinforcing the group’s concerns over the risk of Pradaxa overdoses among older users, since the medication has a “one-size-fits-all” dose.

Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in the United States in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations. It is the first approved anticoagulant from in a new class of medications, known as “direct thrombin inhibitors,” which inhibit the enzyme in the blood that causes blood to clot.

These medications are promoted as superior alternatives to Coumadin/warfarin because they require less monitoring.  However, while users of warfarin who suffer internal bleeding can be treated with Vitamin K to counter the blood thinning effects, Pradaxa and the other newer blood thinners in the same class do not have a quick fix, often referred to as a reversal agent.

While many prescribing doctors have adopted Pradaxa because it requires less follow up visits from their patients to monitor blood levels, emergency room physicians and other experts have raised substantial concerns about their inability to treat Pradaxa overdoses, hemorrhages or other bleeding events that do occur, increasing the seriousness of such events.

Concerns over deaths linked to Pradaxa has sparked safety investigations in the U.S., Europe and Canada. An increasing number of people throughout the United States are also now pursuing a Pradaxa lawsuit, alleging that the drug maker failed to adequately research the medication or warn about the serious and potentially life-threatening side effects.