Loraine Franklin fell on the kitchen floor of her Texas home in December 2011. Less than 24 hours later, the active 80-year-old was dead. Her family says Franklin fell and hit her head which caused an intracranial hemorrhage which could not be stopped in the hospital. There was nothing doctors could do but keep her comfortable as the blood pooled in her brain.
Franklin, like hundreds of other patients, was prescribed Pradaxa after a diagnosis of atrial fibrillation, or an irregular heartbeat that is linked to stroke. Blood thinners are prescribed regularly for this condition. Had she been taking the blood thinner, warfarin, also known as Coumadin, a drug that’s been around for at least 50 years, doctors would have been able to stop the bleeding. Patients can have their blood thickened in an emergency uncontrolled bleed with vitamin K, fresh plasma or PCCs (prothrombin complex concentrates).
Not so with Pradaxa. There is no antidote to the blood-thinning abilities of the drug; because unlike Coumadin, Pradaxa is a thrombin inhibitor and there is no way to emergently cause to the body to begin producing more thrombin to help clot the blood.
Franklin’s family is now suing the drugmaker, Boehringer Ingelheim over a failure to adequately warn the public and doctors about the lack of any antidote to the drug in an emergency.
The Franklin family will be added to the 260 other Pradaxa-related deaths worldwide recorded between March 2009 and October 2011.
Anticoagulants are big business, according to the U.S. Centers for Disease Control and Prevention (CDC), with about 2.6 million Americans diagnosed with atrial fibrillation. The numbers are expected to grow to 12 million cases within 40 years.
Boehringer knew it could aggressively market Pradaxa as a more convenient alternative to Coumadin. The disadvantage to Coumadin is it must be regularly monitored, as often as twice a week to balance the thickness or thinness of a patient’s blood. And with sales in the $10 to $20 billion range, it and seven other pharmaceutical companies began looking for an alternative to Coumadin. Boehringer won with Pradaxa in 2010.
Having a drug on the market for a few years before it is recalled and deemed defective puts the balance sheet in the black even when considering paying to settle lawsuits. It’s the old story of the Ford Pinto and calculating profits versus deaths and injuries.
The company’s RELY study, which showed Pradaxa was superior to Coumadin in reducing stroke, is now being questioned for its reliability among doctors and watchdog groups. The Institute for Safe Medication Practices names Pradaxa as among the top drugs in 2011 in reports of serious adverse events with the exception of one other.
Boehringer insists the risks of Pradaxa were not hidden from the public and the FDA, in lockstep, continues to believe that “Pradaxa produces an important health benefit when used as directed.”
Doctors and Motivations
Dr. Bryan Cotton, a surgeon at the University of Texas Medical School in Houston, was compelled to write to the New England Journal of Medicine in November 2011, when two employees of the University received a Pradaxa prescription by doctors who didn’t mention the lack of any reversal agent. Of 11 of his patients taking Pradaxa, all but three or four died from severe bleeds.
Two Canadian researchers, with financial ties to Boehringer Ingelheim, then came to its defense writing there is no evidence that Pradaxa contributed to two deaths Cotton had related to the drug.
Six months before she died, Loraine Franklin, a former teacher to children with special needs was stooped over and her family had no idea she was bleeding. Her family found tampons and maxi-pads. They feel internal bleeding was making her weak which led to her fatal fall.
The family says the drug robbed them of at least 10 years with their mother who before Pradaxa was socially and physically active.