The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial hemorrhage which doctors were unable to stop.
Franklin’s daughters told the Houston Press that her mother was never told that Pradaxa’s bleeding side effects were irreversible. The 80-year-old former teacher passed away just six months after starting Pradaxa. Emergency room doctors tried to keep her comfortable, but could do little else to stop the brain bleed that took Franklin’s life. Her daughters believe Pradaxa robbed them of maybe ten more years with their mother.
“I would not give Pradaxa to my dog,” daughter Becky Hormann told the Houston Press.
Pradaxa, a blood thinner approved to prevent strokes in people with atrial fibrillation, was brought to market in 2010. According to the U.S. Food & Drug Administration (FDA), approximately 1.1 million prescriptions were dispensed between October 2010 and August 2011. As we’ve reported previously, Pradaxa was marketed as a safer alternative to Coumadin (warfarin), a blood thinner that has been on the market for decades. Among other things, Coumadin can cause dangerous interactions with other drugs. Patients taking Coumadin also have to avoid foods that are high in vitamin K, like leafy greens, liver, green tea and cauliflower. Patients’ blood must also be regularly monitored to ensure it is working well.
Both Pradaxa and Coumadin can cause serious internal bleeding. But Coumadin bleeding can be stopped with the administration of vitamin K. As the case of Loraine Franklin shows, there is no readily available antidote for Pradaxa bleeding.
Last year, Pradaxa’s maker, Boehringer Ingelheim, acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa
In April, the Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury, including 117 bleeding deaths, in the second quarter of 2011. In its previous QuarterWatch report, the ISMP had found that more than 500 cases of serious Pradaxa bleeding had been reported to the FDA in the first quarter of 2011.
Pradaxa Bleeding Controversy
Loraine Franklin’s death is not an isolated case, according to the Houston Press. Houston trauma surgeon Bryan Cotton reported that of 11 patients he treated for severe bleeds while on Pradaxa, all but three or four died. Cotton was one of the authors of a letter published last year in the New England Journal of Medicine that detailed his experience with Pradaxa.
“Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert),” the letter stated. “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.”
After the letter appeared, Cotton said he and his colleagues were contacted by representatives of Boehringer Ingelheim who expressed surprise at their experience, claiming there had not been similar bleeding events in Pradaxa’s clinical trials. The assertion shocked Cotton, who said he found it hard to believe that such side effects weren’t seen in the large studies.
In response to Cotton’s letter, two Canadian researchers with financial ties to Boehringer Ingelheim authored a rebuttal, claiming at while “specific antidotes…are desirable,” there was “no evidence that the lack of an antidote contributed to the deaths” of Cotton’s patients.
In his own rebuttal, Cotton rejected their reasoning, pointing out that the patients came into the ER bleeding, and that “the multidisciplinary team caring for them could not control their hemorrhages.”
“When prescribing a drug with side effects that include life-threatening hemorrhage, reversal is not ‘desirable,’ it is essential,” Cotton wrote.