FDA OKs Drug to Reverse Blood Thinner’s Effec

A fast-acting antidote for Boehringer Ingelheim GmbH’s blockbuster Pradaxa (dabigatran) has won accelerated FDA approval, becoming the first approved agent for reversing the widely used anticoagulant. “The anticoagulant effects of Pradaxa are important and life-saving for a few patients, but there are situations where reversal of the drug’s effects is medically necessary”, said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a released statement. Both are produced by Danbury-based Boehringer Ingelheim. The approval follows Boehringer Ingelheim’s submission of a biologics license application for Praxbind in March 2015.

As for the unblinded clinical trial (meaning researchers knew which subjects were taking the experimental drug) used to earn Pradaxa approval, POGO notes that “FDA tolerated sloppiness and arguably loose controls on the part of the drugmaker in its management of the clinical trial”.

-The government approved the drug knowing that there was no antidote to stop patients from hemorrhaging by thickening their blood when treatment went awry. Intravenously administered Praxbind was developed specifically for use with Pradaxa.

POGO asked cardiologist Steven Nissen of the Cleveland Clinic how he would treat Pradaxa patients who arrived with a hemorrhage, and Nissen “gave POGO a succinct answer that was only partly in jest”: “Pray”, he said.

Effects of Pradaxa, a blood-thinning drug marketed by Boehringer Ingelheim, can be neutralized by injecting the new drug into patients, said FDA.

Jerry Avorn, a professor at Harvard Medical School, also wrote that the FDA’s analysis behind its statements defending Pradaxa was “unsuitable for informing the care of patients”.

In 2014, Boehringer agreed to pay $650 million to settle roughly 4,000 claims alleging that the company did not warn the public about the risks of uncontrolled bleeding with Pradaxa. The watchdog calls on the FDA for a stronger emphasis on drug safety in its approval process and “higher standards” in clinical trials.

As blood thinners, Pradaxa, Xarelto and Eliquis are all meant to be more convenient alternatives to warfarin, an oral anti-coagulant that has been sold for more than 60 years but which comes with serious bleeding risks, hard dietary restrictions and the need for routine blood monitoring. According to POGO’s investigation and materials received by the FDA through Freedom of Information requests, Nissen described the issue as “the elephant in the room”.

Officials with the FDA said that while they don’t comment on specific studies, the agency “evaluates them as part of the body of evidence to further our understanding about a particular issue”.