Popular blood thinner Pradaxa maker withheld critical safety data
One of the things that healthcare service providers need to know about the medicines they prescribe is the safety of the drug. Patients need to be aware of the risks associated with their medications as well. One pharmaceutical company, however, is alleged to have withheld important safety data about its blockbuster blood thinner which could have saved lives and prevented serious reactions.
A set of articles published in the BMJ on Wednesday, July 23, suggests that Boehringer Ingelheim may have knowingly failed to report important safety information about its drug dabigatran (Pradaxa) from US and UK regulators. The drug is a bestselling prescription medication intended to reduce the risks of stroke in patients with atrial fibrillation, a heart rhythm disorder associated with fainting, chest pain, palpitations and chronic heart failure.
Among the main selling points of Pradaxa, which was approved by the Food and Drug Administration (FDA) in 2010, is that it does not require frequent blood plasma monitoring, which is needed with the older drug Coumadin. Some of the patients using Pradaxa, however, reported of bleeding problems.
In order to determine if monitoring the levels of the drug in the blood of patients would reduce bleeding complications, researchers from the Institute for Safe Medication Practices (ISMP) at the University of Ottawa looked at Boehringer Ingelheim's own data to examine the effects of blood level monitoring on Pradaxa use.
They found that monitoring the blood levels of the patients periodically could have allowed doctors to lower the dose of the drug or stop it temporarily in patients who have dangerously high levels of Pradaxa in their blood. The researchers said that Boehringer Ingelheim's data suggest that up to 40 percent of all serious bleeding events and deaths that were associated with use of the drug could have been prevented by simple blood testing.
The researchers claimed that the company had been aware of this even before the drug was green-lighted by the FDA but apparently withheld this information during the approval process of Pradaxa citing four internal reports of company scientists raising concerns about the risks of serious bleeding which may have been ignored by their superiors.
"Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible," BMJ's investigations editor Deborah Cohen wrote.
Boehringer Ingelheim maintains that its drug is safe.
"Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating the efficacy and safety profile of Pradaxa, and FDA and European Medicines Agency (EMA) have affirmed RE-LY's conclusions and stated that Pradaxa provides an important health benefit when used as directed," Boehringer Ingelheim said in a statement.