Boehringer Ingelheim, a drug manufacturer, has come under fire for failing to report safety information to drug regulators in the United Kingdom and United States, according to recent reports.
As articles in the BMJ have suggested, the company may have knowingly lied about the safety of one of its bestselling drugs. The drug, Pradaxa, is a medication available through prescription that purports 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.
Praxada was approved by the Food and Drug Authority in the United States in 2010, and of the main advantages it had over its competitors is that it does not require frequent blood plasma monitoring, which is needed by most other drugs that treat the ailment.
However, as reported in the BMJ, many patients have started suffering from bleeding problems which are said to be caused by the drug. The BMJ articles have also insinuated that the taking of Pradaxa was one of the only common factors between each of the patients, aside from the original ailment which needed treatment. According to BMJ’s investigations editor, Deborah Cohen:
“Boehringer Ingelheim, the maker of dabigatran [Praxada], 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.”
Although evidence purports to show the contrary, Boehringer Ingelheim has maintained that the drug is safe, going so far as to say that:
“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.
Deborah Campbell
