Pradaxa Drug Maker May Have Suppressed Compromising Report

Pradaxa is a blood-thinning medication manufactured by pharmaceutical company Boehlinger Ingleheim for the treatment of a heart condition called atrial fibrillation. The drug was developed to replace an older drug, warfarin, which required frequent blood tests to monitor clotting levels. The U.S. Food and Drug Administration approved the drug for sale in 2010, but since that time, a number of deaths have been associated with its use. Now, internal documents indicate that the company was aware of a study with negative results that they chose to ignore in order to continue marketing the drug’s advantages.

The Problem Study

Documents regarding a study conducted by Paul A. Reilly that showed some patients might need monitoring of their blood while taking Pradaxa were given short shrift because the company had leaned so heavily on marketing the drug as different than older drugs that required regular blood monitoring. One company supervisor, Dr. Jutta Heinrich-Nols, discouraged publishing the paper which would conflict with the drug’s marketing program. Another company employee, Dr. Andreas Clemens, voiced concerns about legal repercussions if the results of the study became known.

Variations in Drug Reaction

Another problem with the drug was an unexplained variation in patient absorption. Testing showed that some patients were not able to absorb a sufficient amount of the drug, and others absorbed excess amounts of it. Because no test exists to tell in advance how the patient will metabolize the drug, there was no basis on which to vary the dosage.

Questions About Pradaxa

The study reinforces questions about Pradaxa’s safety that have been swirling since the drug’s introduction to the public in 2010. Uncontrolled bleeding episodes have been linked to Pradaxa over past years. In addition, no antidote is available for excess levels of Pradaxa in the bloodstream, unlike older drugs. About 2.2 million prescriptions for Pradaxa have been filled by patients.

Those Who Take Pradaxa

Patients who have been prescribed Pradaxa for atrial fibrillation should discuss the risk of complications from using the drug with their doctor.

Sources:
http://www.huffingtonpost.com/2012/06/14/pradaxa-xarelto-blood-thinner-doctors-heart_n_1595971.html
http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html