FDA Evaluating Pradaxa Bleeding Reports

Washington, DCThe US Food and Drug Administration (FDA) has announced that it is evaluating reports of Pradaxa bleeding, as the new blood thinner from Boehringer Ingelheim GmbH has been linked with reports of this side effect, according to MarketWatch.

The news source reported that the FDA said it continues to believe that the drug provides an important health benefit when used as directed, and patients on the medication with a heart-rhythm disorder should not change their regimen prior to talking to their doctors.

The FDA said that stopping the use of blood-thinning medications can increase the risk of stroke for patients, which can lead to a permanent disability or death, according to the news source.

Pradaxa is known as an anticoagulant that is designed to reduce the risk of blood clots and stroke in people with atrial fibrillation. It was initially approved by the FDA in October 2010. It is one of a new class of blood thinners that can be used in place of an older drug, warfarin, which can be difficult to administer to subjects, MarketWatch reported.

The news source reported that Pradaxa's prescribing label and a guide to the medication carry the warning that the drug can cause serious and sometimes fatal bleedings. However, it was cleared by regulators based on data compiled from clinical trials showing it reduced the risk of strokes when compared with older products like warfarin.

According to Forbes, the FDA said it was "working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected."

The FDA also noted that it is difficult to compare bleeding complications with dabigatran and with warfarin, because complications associated with the older drugs may be less likely to provoke an adverse event report, the news source reported.

According to the news source, patients who are taking the drug should report any side effects that they experience to their health care professional.