FDA Approves New Drug to Reverse Blood-Thinning Effects of Pradaxa

The U.S. Food and Drug Administration Friday approved the first medication created to reverse the effects of the blood-thinning drug Pradaxa to lower the risk of excessive bleeding during surgery.

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

The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, the FDA said. "Today's approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled".

A humanized antibody fragment, designed as a specific reversal agent to Pradaxa, Praxbind binds specifically to dabigatran molecules only, neutralizing their anticoagulant effect without interfering with the coagulation cascade.

-The FDA approved Pradaxa on the basis of a single clinical trial.

A national watchdog group called attention to the issue again earlier this week by calling into question the initial approval process used by the FDA when Pradaxa was approved.

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. (Boehringer Ingelheim is now developing an antidote). Perosphere, another Danbury-based pharmaceutical company, also has an antidote for Pradaxa that is still in the trial stage.

The group also said the FDA relied on an "unblinded" trial to approve the drug in which doctors were aware of who was receiving the experimental drug and, according to the investigation, handled them differently.

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.

-Although Pradaxa can cause fatal bleeding - dangers acknowledged in the fine print of the product's package insert - the FDA has not required the drug to carry a more conspicuous "black box" warning about those hazards.

-Members of the FDA advisory committee that reviewed and endorsed the drug by a vote of nine to zero had ties to the pharmaceutical industry. But President and CEO Paul Fonteyne said it had been set to "ensure the likelihood that it can be available at institutions where Pradaxa patients seek emergency care".