Despite Serious Pradaxa Side Effects, British Health Agency Pushes Use

Despite increasing reports of serious Pradaxa side effects, a British health agency is recommending more widespread use of the drug as treatment for atrial fibrillation.

The National Institute for Health and Care Excellence (NICE) recently released new guidelines for atrial fibrillation patients using anticoagulants to prevent stroke and other complications. In the guidelines, the agency suggested only 45 percent of the patients that should be taking Pradaxa or Xarelto were actually prescribed the drugs.

NICE notes benefits of Pradaxa

The agency noted the benefits provided by Pradaxa and Xarelto in preventing strokes in patients diagnosed with atrial fibrillation. Originally, these anticoagulants were marketed as a more convenient alternative to the older blood-thinning medication warfarin, because these new products did not require the same ongoing monitoring or dietary restrictions required with warfarin use. However, adverse event reports associated with these newer drugs suggested the risk of serious and even deadly bleeding events was higher with both Pradaxa and Xarelto than with warfarin.

In their guidance, NICE recognizes the bleeding risk associated with these drugs. The agency includes a chart in their recent publication that helps patients to assess bleeding risk based on other factors like age, kidney function and other influences. However, NICE also encourages patients to consider these drugs over warfarin, due to their effectiveness in stroke prevention.

Pradaxa (dabigatran) was first introduced to the U.S. market in 2010 and Xarelto followed one year later. While these drugs have quickly become top-selling treatments for patients with certain types of atrial fibrillation, a serious problem with these drugs has since come to light. Unlike warfarin, there is no antidote for Pradaxa or Xarelto if bleeding occurs from an injury or surgery. This has led to potentially deadly situations for some patients, as the bleeding can be very difficult for physicians to control.

Significant percentage of bleeding events

According to the Institute for Safe Medication Practices, one clinical trial involving dabigatran indicated 16 percent of patients on the drug would have a bleeding event within one year. Nearly four percent would have a serious enough event to require emergency medical treatment. The organization has made recommendations to decrease the bleeding risk, by providing a lower dosage option or assessing patients to determine which ones had a higher risk of bleeding on the drug.

In May 2014, the FDA issued an updated safety communication regarding Pradaxa. The agency stated that while the drug offered a lower risk of stroke, brain hemorrhage and death for patients with atrial fibrillation, it also was associated with a higher risk of gastrointestinal bleeding. The agency is also continuing to collect adverse reports related to Pradaxa in order to monitor the safety and potential risks of the drug.

Those who have been injured by Pradaxa or Xarelto may choose to file a lawsuit alleging they did not receive adequate warning about potential Pradaxa side effects. Currently, there are more than 2,500 such claims against Pradaxa manufacturer Boehringer Ingelheim pending in multidistrict litigation in U.S. District Court for the Southern District of Illinois. The defendant recently negotiated settlements for another 4,000 injured Pradaxa users nationwide.

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