New studies have revealed that anticoagulant drug Pradaxa increases risk of heart attack. Pradaxa is an anticoagulant drug containing Dabigatran as its main active ingredient. It belongs to direct thrombin inhibitor group of drugs.  It prevents clotting in the blood. It is used as blood thinner in patients who have clot problems or risk of blood clotting. It is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

It is prescribed to patients of heart disorder for prevention of blood clots and hence reducing the risk of stroke. Sometimes clots break free from their point of origin and circulated with the blood and can even move to a blood vessel of the brain, and block blood flow to the brain. Due to this strokes are caused. By preventing clots Pradaxa lowers risk of stroke in the patient. Blood clots could also travel to heart or lungs and could cause serious complications. Thus Pradaxa is used to reduce risk of blood clotting and other related serious health complications.

It is a blood thinner and makes bleeding easier, thus any minor cut or injury increases risk of heavy bleeding, while using Pradaxa. This medicine has been linked with unusual and unexplained bleeding in various part of body. It could also lead to internal bleeding. But it has been found out in studies that use of Pradaxa leads to 33% higher risk of heart attack or other heart complication in the patients compared to other drugs.

The study was conducted by Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD. They studied 30,514 patients from seven clinical trials. They concluded that the risk of heart attack or acute coronary syndrome increases in patients using Pradaxa. They compared it with various control treatments including Warfarin, and other placebo. Acute coronary syndrome occurs due to the rupture of a plaque in a heart artery.

The FDA is already investigating reports of side effects linked with Pradaxa. There are many reports of serious bleeding due to use of Pradaxa. Not only in U.S. safety concerns about this drug is also raised in Japan, Australia and Europe. They have already issued safety warning regarding Pradaxa. FDA has also issued a warning about drug’s break down quickly when removed from its container. These additional concerns have added to the safety concerns related to this drug.

The study concluded that risk of heart attack or acute coronary syndrome in patients on Pradaxa increases 0.25% per year. This is highly risky for patients who already have other risk factors of heart diseases.

Boehringer Ingelheim responds to this revelation stating that the study was not done well. They claimed that the study was not large enough to be significant scientifically. The company maintains that the benefit of Pradaxa is more than risks involved with it. It is proven by studies, claiming its link with hear attack, too. It also asked to not combine different studies comparing Pradaxa to other drugs, to measure risks involve with it.

Company maintained that safety of patients taking its medicines is top priority for them. They are also going with different clinical analysis to ensure safety of drugs manufactured by them. They actively monitor clinical trials with FDA and other regulatory agencies.