Blood Thinner Pradaxa (Dabigatran) Maker accused of Hiding Safety Data

A group of researchers have made some startling revelations about a widely recommended blood thinner drug used to treat heart woes.

Blood thinners are the anticoagulants which prevents the coagulation of blood in the arteries. Thus preventing problems like myocardial or cardiac ischemia (heart attack). Some of the widely used blood thinners in the United States are warfarin, heparin.

Another blood thinner which acts directly by inhibiting the thrombin is dabigatran.

Drug maker Boehringer Ingelheim has been accused of intentionally hiding some important information about its drug dabigatran (Pradaxa), used to treat serious heart related issues including a heart rhythm disorder, in patients with atrial fibrillation that causes chest pain, palpitations and chronic stroke.

The revelation about the bestselling prescription medication was made in a series of articles that were published in the journal BMJ.

The complain has come from regulators in the UK and US. The researchers in their report have alleged that the company has intentionally missed out revealing important safety information about the highly used drug.

Pradaxa had got the green signal from the Food and Drug Administration (FDA) in 2010. The makers have said that the drug does not need frequent blood plasma monitoring. But some Pradaxa users reported of bleeding problems.

This discrepancy led to the dire need for knowing if level monitoring of the drug in the patients’ blood would reduce bleeding complications

In order to figure out this, scientists at the Institute for Safe Medication Practices (ISMP) in University of Ottawa analysed the data from Boehringer Ingelheim and checked the effects of blood level monitoring on the drug use.

The researchers found that the periodical monitoring could have made doctors to minimise the Pradaxa dose or temporarily stop it in those patients who are at dangerously high risk.

Deborah Cohen, BMJ’s investigations editor, said, “Boehringer Ingelheim 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 poss