Pradaxa Problems Raise Concerns Among Consumers, Doctors

Experts and regulators are growing more and more concerned over Pradaxa bleeding problems, causing individuals who experienced serious and life-threatening injuries to question whether the drug maker failed to adequately warn about the risk. 

After just one year on the market, side effects of Pradaxa have been linked to more than 360 deaths from internal bleeding problems, which is more than five times greater than the manufacturer, Boehringer Ingelheim, initially reported.

Last month the FDA issued a drug safety communication announcing an investigation into post-marketing reports of serious bleeding problems with Pradaxa.

Those post-marketing reports are being made by doctors and patients who experience Pradaxa problems, and that appears to be a very large number of Pradaxa users and prescribers.

In October 2010, researchers looked at data on Pradaxa clinical trials used to gain approval for the drug and indicated that the study was fundamentally flawed and should have never been used to establish the drug as a safe and effective treatment for prevention of strokes among patients with atrial fibrillation.

According to a report released last year by the Institute of Safe Medication Practices (ISMP), the FDA received hundreds of complaints about Pradaxa problems within weeks of its release. Most of the cases involved internal bleeding among elderly users. Overall, the FDA received 307 complaints about Pradaxa during the first three months it was on the market, which far exceeds the 202 reports involving problems with warfarin, which has been on the market for decades.

Some patients and doctors report that the drug sometimes had too much of an effect on clotting, leading to hemorrhages. Other reports indicate that at times it does not have enough of an effect, resulting in pulmonary embolism or deep vein thrombosis.

Pradaxa (dabigatran) was only released in October 2010. While the drug is meant to be a replacement for warfarin and is supposedly easier to use and requires less monitoring, warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs. However, there is no such quick fix for a bleeding problem with Pradaxa.

As concerns rise among federal regulators and the medical community, a number of Pradaxa lawyers are reviewing potential lawsuits on behalf of individuals throughout the United States, alleging that Boehringer Ingelheim failed to adequately warn about the risk of internal bleeding.