The Food and Drug Administration (FDA) issued a Drug Safety Communication recently informing the public and health care professionals that the blood thinner Pradaxa (dabigatran) should not be used in people with mechanical heart valves.
Forbes reported that the drug’s manufacturer, Boehringer Ingelheim, has told its Pradaxa clinical trial investigators that it will be sending a Direct Healthcare Professional Communication (DHPC) – also known as a “Dear Doctor Letter” – to health care professionals. The letters are based on the FDA’s recent decision and will inform doctors that Pradaxa is contraindicated in patients with mechanical heart valves.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recommended that the drug should not be used in patients with artificial heart valves. This announcement came a week before the FDA’s Drug Safety Communication.
More Strokes, Heart Attacks Caused by Pradaxa than Warfarin
The FDA and EMA made their recommendations based on the findings of the RE-ALIGN clinical trial. The Boehringer-sponsored trial was stopped prematurely when participants with mechanical heart valves using Pradaxa began experiencing strokes, heart attacks and blood clots forming on valves. The same risk of these side effects did not apply to those using warfarin. There was also a higher incidence of bleeding after valve surgery in those using Pradaxa.