Pradaxa on two types of trials

Boehringer Ingelheim Pharmaceuticals is putting its prescription blood thinner Pradaxa (dabigatran etexilate) to a test that injured plaintiffs in Pradaxa lawsuits, including some next-of-kin, might say the manufacturer already failed.

“Pradaxa is an anticoagulant medicine that may help prevent blood clots from forming in your body and causing a stroke,” according to the FDA, which in 2010 approved the drug. It is used in the treatment of patients with the common heart rhythm abnormality non-valvular atrial fibrillation. Its Medication Guide reads, in part, “Pradaxa can cause bleeding which can be serious and sometimes lead to death.” There is no antidote for Pradaxa-induced bleeding.

Researchers estimate that Boehringer Ingelheim’s clinical trial will recruit “1,200 patients with non-valvular atrial fibrillation not previously treated with Pradaxa and free of gastrointestinal symptoms for at least 12 months prior to enrolment,” according to information made available by the National Institutes of Health. The patients, who will be examined at 60 to 80 North American sites, will be treated with Pradaxa for three months at either of two dosage strengths.

Those patients who develop gastrointestinal symptoms will be placed randomly in “one of two management strategies, and [at intervals of four weeks and eight weeks] data documenting the intensity and duration of the GIS will be collected,” a summary of the clinical trial reads.

One group suffering from gastrointestinal symptoms will take pantoprazole, which reduces stomach acid, and the other will take Pradaxa within 30 minutes after a meal. Researchers will record any adverse events as well as the varying levels of relief that participants may experience. The analysis is expected to be completed in September.

The participants in this clinical trial will know up-front that their treatment is being monitored for an “open label” experiment, in which patients will know what they are taking. Researchers also will know throughout the trial who is taking what.

But arguably thousands of Pradaxa bleeding victims have become, in effect, unwitting participants in reckless and failed experimentation that involved their unnecessary exposure to unreasonable risks — seemingly circumstances that dutiful science and thorough product warnings could have either precluded or minimized.

No matter the outcome of the clinical trial, Pradaxa lawsuits have been filed on behalf of those who have suffered bleeding and other gastrointestinal events associated with the increased risks of taking the drug. The experienced pharmaceutical injury litigation team at Reich & Binstock [www.reichandbinstock.com] represents Pradaxa victims.

The nonprofit Institute for Safe Medication Practices tracked Pradaxa-related adverse events that in 2011 the manufacturer and others combined reported to the FDA. The figures included 542 patient deaths. Further, among the “regularly monitored drugs,” Pradaxa had the highest 2011 case reports of hemorrhage (2,367), acute renal failure (291) and stroke (644).

The Pradaxa attorneys at Reich & Binstock offer a free consultation to anyone whose injuries may have been linked to taking the drug. Operating in all 50 states, Reich & Binstock may be reached toll-free at 1-866-LAW-2400.