Pradaxa Side Effects - Consumer Justice Foundation

Pradaxa Side Effects

Written by Faith Anderson on April 9, 2012
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Elderly Patients Most at Risk for Pradaxa Bleeding Side Effects

Pradaxa (dabigatran) was approved by the FDA in October 2010, and was touted as a superior alternative to warfarin, a blood thinner that has been on the market in the United States for nearly sixty years. Pradaxa is the first approved anticoagulant from a new class of medications called direct thrombin inhibitors, which interfere with the enzyme that causes the blood to clot. Pradaxa is commonly used to prevent blood clots and stroke in patients with atrial fibrillation, a condition in which the heart beats irregularly.

According to the ISMP report, Pradaxa was associated with 856 reports of serious, disabling or fatal injury during the second quarter of 2011, including 117 deaths and 511 instances of internal bleeding side effects. Most of the reported internal bleeding cases involved patients over the age of 80, reinforcing the group’s concerns regarding the risk of Pradaxa overdose among elderly users, since the drug offers one dose for all patients.

Lack of Pradaxa Reversal Agent Increases Severity of Bleeding Events

When Pradaxa first entered the market, it was believed to be superior to warfarin because it required less monitoring. Unfortunately, while warfarin patients who suffer from internal bleeding can be treated with Vitamin K, a reversal agent that can counter the dangerous blood thinning effects, there is no reversal agent available for patients suffering from Pradaxa internal bleeding side effects, thereby increasing the risk of fatal injury.

While many healthcare providers have prescribed Pradaxa to their patients because it requires less follow-up visits to monitor blood levels, emergency room physicians and other experts have voiced their concerns about the inability to treat Pradaxa overdoses, internal bleeding or hemorrhaging events that do occur, increasing the severity of such side effects. Concerns over deaths associated with Pradaxa has sparked a safety investigation into the blood thinner in the U.S., Canada and Europe. Pradaxa patients across the country who have suffered from Pradaxa side effects are now pursuing a Pradaxa lawsuit, alleging that Boehringer Ingelheim failed to adequately research the drug or warn consumers about the serious and potentially fatal side effects associated with the medication.

Posted Under: United States
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