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A widely recommended blood thinner which is used for treating cardiovascular disease is under the scanner of some medical researchers who have claimed that its manufacturer have hidden some crucial facts about the drug. If you’re among the patients who are on blood thinners, then this news is for you.
Boehringer Ingelheim has been accused of intentionally hiding some important information about its drug dabigatran (Pradaxa).
The regulators in the UK and US have complained about the drug.
The blood thinner is used to treat serious cardiovascular diseases including a heart rhythm disorder in patients with atrial fibrillation that causes chest pain, palpitations and chronic stroke.
The investigators made the revelations about the bestselling prescription medication in a series of articles, published in the journal BMJ. The researchers in their report have alleged that the company has intentionally missed out revealing important safety information about the highly used drug.
Blood thinners, the anticoagulants, helps in preventing the blood coagulation in the arteries.
The Food and Drug Administration (FDA) has approved Pradaxa in 2010. At that time, the drug maker has said that the blood thinner does not need frequent blood plasma monitoring, but some of its users reported of bleeding problems. This difference generated curiosity among the researchers who wanted to know if monitoring of the drug level in the blood of the patients would reduce bleeding complications.
To find out the researchers from Institute for Safe Medication Practices (ISMP) in University of Ottawa collected the data from Boehringer Ingelheim and checked the monitoring effects of blood level on the drug use.
The study showed that the periodical monitoring must have helped the doctors to minimise the Pradaxa dose or even stop it temporarily in those patients who are at high risk.
Refuting the charges in its report, Boehringer Ingelheim said that they carried a study to understand the effect of blood-level testing and also analysed the dose adjusting but found that it was not needed.
“The truth is the totality of scientific evidence does not support dosing decisions for Pradaxa based on blood levels. Other factors like how well kidneys work, affect the risk of bleeding too,” the statement said.
When asked about the issue, Sandy Walsh, an FDA spokesperson, said, “At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that health care professionals who prescribe Pradaxa follow the recommendation in the approved drug label.”
Some of the other widely used blood thinners in the United States are heparin and warfarin.
Whatever be the case, but experts say there is an urgent need of more refined researches to check the efficacy of this blood thinner.