Daughters Allege Their Mother Died From Pradaxa Bleeding

May 28, 2012, 11:15AM. By Gordon Gibb

Georgetown, TXThe potentially premature death of a much-loved mother and teacher, coupled with the observations of various surgeons raises concerns about a drug that was meant to effectively update a much older, finicky blood thinner used to prevent blood clots. Instead, Pradaxa side effects can be deadly—because once bleeding starts, there is virtually no way to stop it.

The family of Loraine Franklin knows this all too well. As chronicled in the Houston Press (5/24/12), the retired schoolteacher had been suffering from uncharacteristic weakness. Normally robust and energetic even at 80, the patient had been taking dabigatran (Pradaxa) for six months when she suffered a fall and struck her head. The blow unleashed an intracranial hemorrhage inside her skull, bleeding which doctors could not control. She died allegedly from Pradaxa bleeding.

Franklin's family has pursued legal action, one of numerous Pradaxa lawsuits launched against the manufacturers of the allegedly problematic drug originally designed as an improvement over the old. However the new, it appears, has problems of its own.

Dabigatran, the generic term for Pradaxa, was designed to help prevent heart attacks and the blood clots that sometimes cause them, by thinning out the blood. Such blood thinners have been used by the medical community for decades—including warfarin, dispensed under the brand name Coumadin. While the latter came with a shopping list of challenges doctors needed to meet in order to manage the drug properly, there was one advantage Coumadin has that Pradaxa doesn't…

The capacity to stop bleeding once it starts.

In other words, a means to reverse the effects of a blood thinner. When a bleeding crisis occurs, doctors require a way to persuade the blood to clot again. Coumadin allows a doctor various options to reverse its effects. Pradaxa, on the other hand, allows just one response—and it only works if bleeding is caught early. A Pradaxa patient suffering from serious bleeding requires immediate dialysis to expel any Pradaxa remaining in the blood.

However, the capacity and availability for that one means of reversal is limited at best. Houston-based trauma surgeon Bryan Cotton, together with two colleagues, co-authored a letter to the editor of the New England Journal of Medicine (NEJM) in November of last year, outlining his concerns about dabigatran, and the Pradaxa deaths he has encountered.

"Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert)," they wrote. "The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers."

Cotton, an associate professor of surgery at the University of Texas Medical School at Houston and a physician-scientist in coagulation research at the Center for Translational Injury Research, told the Houston Press that of 11 patients who suffered severe Pradaxa bleeding, all but three or four died.

Pradaxa manufacturer Boehringer Ingelheim recorded 260 Pradaxa deaths worldwide between March 2009 and October 2011. While the US Food and Drug Administration (FDA) is conducting a post-market safety review of Pradaxa, the regulator "continues to believe that Pradaxa provides an important health benefit when used as directed."

Tell that to the family of Loraine Franklin. After her death, Franklin's daughters were going through their mother's things and found tampons, suggesting their mother had a problem with vaginal bleeding. They feel the bleeding formed the cause of her overall weakness and deteriorating strength, eventually causing the fall that hastened her death. They have launched a Pradaxa lawsuit in federal court, alleging that Boehringer failed to warn doctors and patients about the lack of an antidote.

The manufacturer also told the Houston Press that 260 recorded deaths are not outside the parameters of the RELY clinical trial used by the FDA and other regulators worldwide to approve Pradaxa.