Pradaxa Makers Scrutinized Over FDA Statement, Safety Study

Drug maker Boehringer Ingelheim Pharmaceuticals has been receiving intense legal scrutiny over its drug Pradaxa. The attention over Pradaxa has recently intensified over recent concerns from the U.S. Food and Drug Administration and a press release from Boehringer Ingelheim itself.

Pradaxa is a type of drug called an anticoagulant, or blood thinner. Anticoagulants make it more difficult for blood to clot. Since serious health problems like strokes, pulmonary embolisms, and some types of heart attack are caused by errant blood clots, drugs like Pradaxa can help certain high-risk patients reduce their chances of suffering from these medical emergencies. However, all anticoagulants carry the risk of being too good at their jobs. When patients can’t form blood clots at all, they can bleed to death from very minor injuries. It has been alleged that Pradaxa is more dangerous in this respect than older, off-patent anticoagulants.

On May 13, the FDA issued a Safety Announcement that indicated the agency had completed an analysis of the safety of various anticoagulants, including Pradaxa. In the study the FDA compared the effectiveness and complications of Pradaxa to other anticoagulants. While the FDA did find that Pradaxa patients had a lower risk of stroke, they also found that Pradaxa patients suffered a higher risk of gastrointestinal (GI) bleeds, some of which were fatal. GI bleeds are events in which small injuries to the intestines cause massive internal bleeding. While most people can suffer minor injuries to such tissues without noticing, a person on blood thinners could experience life-threatening internal bleeding. The FDA stressed that patients should not stop taking Pradaxa without talking to their physicians, but urged health care professionals and patients to report any serious side effects to the FDA’s MedWatch Program.

Additionally, Boehringer Ingelheim is facing scrutiny over a recent press release. In the press release, company reps indicated that several patients had been excluded from the final data of the initial safety tests for the drug. The company maintains that the cases were excluded from the study for legitimate medical and scientific reasons. For example, one patient experienced serious bleeding, but only after having a serious car accident. Due to the intense legal pressure and Pradaxa lawsuits Boehringer Ingelheim is facing, such an admission could be dissected to try and determine if the company was suppressing data from the drug’s initial safety studies.

Currently, Boehringer Ingelheim is facing a type of group litigation called multidistrict litigation or MDL. MDLs are a coordinated group of lawsuits, similar in some way to the more familiar class action lawsuit. In both class action lawsuits and MDLs, a group of plaintiffs allege that they have suffered similar harm at the hands of the same defendants. The main difference is that class action lawsuits start out as group lawsuits, while MDLs start out as individual cases that are later combined into a single coordinated legal preceding.

The Pradaxa MDL is formally titled In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Join a Free Pradaxa Class Action Lawsuit Investigation

If you or a loved one were medically diagnosed with internal bleeding problems after using Pradaxa, you may be able to take legal action against the drug’s manufacturer. Joining a Pradaxa class action lawsuit or filing an individual Pradaxa lawsuit may help you recover compensation for medical bills, pain and suffering, and other damages. Obtain a free case evaluation now:

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