Pharmaceutical company under fire for withholding safety information

Pharmaceutical company under fire for withholding safety information

Adverse reactions and deaths associated with Pradaxa use could have been prevented.

The maker of the the popular blood thinner dabigatran, commonly known as Pradaxa, is under scrutiny for withholding important safety information about the bestselling drug from both health and drug regulators, as well as the public. Pradaxa is a newer drug equivalent of Coumadin, prescribed for patients with atrial fibrillation to reduce the risk of stroke. Atrial fibrillation is the most common type of irregular heart rhythm disease (arrhythmia), causing fainting, chest pains, palpitations and chronic heart failure.

The data against Boehringer Ingelheim alleges that had the company been transparent about all the side effects of the drug, up to 40 percent of the deaths and adverse reactions associated with Pradaxa use could have been prevented. The studies were published in theĀ BMJ on July 23 by researchers from the Institute for Safe Medication Practices (ISMP) at the University of Ottawa. Researchers examined Boehringer Ingelheim’s own data to determine if frequent monitoring of Pradaxa levels in the blood of patients would help reduce bleeding incidences.

The investigation followed a series of patient complaints of bleeding problems from Pradaxa use. Pradaxa was approved by the United States Food and Drug Administration (FDA) in 2010 under the major selling-point claim that frequent monitoring of blood plasma is not necessary, as was the case with Coumadin.

The studies found that Boehringer Ingelheim had failed to share the potential benefits of regular monitoring of anticoagulant activity and adjusting the doses as needed for optimal safety and efficacy of the drug. It was further found that the company withheld data and analyses calculating the prevention of major bleeds with dose adjustments. The company cited unreliable prediction of patient outcomes as the reason for excluding this analysis from regulators, according to a report by BMJ’s Deborah Cohen.

Researchers urged that up to 40 percent of all serious bleeding events and deaths could have been prevented had the patients simply had their blood monitored, and doses of Pradaxa adjusted accordingly.

The pharmaceutical company issued a statement stating its renewed submission of all data and analyses associated with Pradaxa to the FDA as well as the European Medicines Agency (EMA) received confirmation of the safety of the drug when used as directed.

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