Posted on November 3, 2012 · Posted in Brain Injury

Some might say that logic dictates you don’t allow a company to put a drug on the market that doesn’t have an antidote, or has been linked to hundreds of deaths. But that is not what the Food and Drug Administration said about Pradaxa on Friday.

Pradaxa, produced by the German company Boehringer Ingelheim, is a blood thinner prescribed to ward off strokes. It has a number of advantages over a similar drug, warfarin, whose brand name is Coumadin. And Pradaxa has become a $1 billion drug after being approved and on the market only two years.

There’s just one small problem with Pradaxa: It’s been linked to the bleeding deaths of some who took it. In fact, more than 100 lawsuits have been lodged over the drug, “and lawyers say thousands more are expected,” The New York Times wrote Saturday.

The Times did a story on the anti-stroke drug Pradaxa headlined “A Promising Drug With a Flaw.” The article starts out with an interview with a trauma surgeon at Houston’s Memorial Hermann-Texas Medical Center, a doctor who maintains that Pradaxa played a part in the bleeding deaths of at least eight patients there.

In fact, The Times reported that Pradaxa has been linked to more than 500 deaths in the United States. To me, that makes is particularly astonishing that the FDA gave Pradaxa a clean bill of health, so to speak, on Friday. The drug’s critics say it should not prescribed for patients until it has an antidote, something that can counteract its blood-thinning effects so people don’t bleed to death when something goes awry.

The FDA said it had evaluated new information about the risk of serious bleeding associated with Pradaxa. No problem, according to the agency.

“Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users,” the FDA said.

“As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin,” it wrote. “

“This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.”

Hence, the FDA said it wasn’t changing its recommendations regarding Pradaxa.

“Pradaxa provides an important health benefit when used as directed,” the FDA said.

Boehringer Ingelheim also put out a statement last week, saying that it will report on the Pradaxa trial cited by the FDA at the American Heart Association (AHA) meeting next week in Los Angeles.

“The wealth of evidence being presented for Pradaxa at this year’s AHA sheds light on the clinical, long-term and real-world benefits of the treatment for patients at risk for thromboembolic events worldwide,” the drug maker said.

Blood thinners such as Pradaxa and Coumadin are prescribed to prevent strokes in people who have atrial fibrillation, a heart-rhythm disorder.

The bad news is that according to The Times, Pradaxa was cited as “the primary suspect” in the deaths of 542 patients last year.

Dear FDA, that is not safe enough.

About the Author

Attorney Gordon S. Johnson, Jr.
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice :: 800-992-9447