The U.S. Food and Drug Administration (FDA) is warning against using the blood thinner Pradaxa in patients who have mechanical prosthetic heart valves. According to a news report in Cardiology Today, FDA is informing healthcare professionals and the public that dabigatran etexilate should not be used to prevent strokes in patients with mechanical prosthetic heart valves.

The FDA announcement came after a clinical trial in Europe that was halted after it was found that patients given Pradaxa or dabigatran etexilate were more likely to experience strokes and myocardial infraction forming on the mechanical heart valves compared with patients who were assigned warfarin. There was also more bleeding after valve surgery in Pradaxa users than in warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.

Strong Pradaxa Warning Issued

The FDA release states that health care professionals should immediately stop using Pradaxa on any patient who has a mechanical heart valve. Also, the alert warns patients with all types of prosthetic heart valve replacements taking Pradaxa to talk to their doctor as soon as possible to determine the appropriate course of treatment. Patients should not stop taking blood thinners without first talking to their doctor because it could increase the risk of blood clots and stroke among patients.

Protecting Patients’ Rights

This study further points to the risks of Pradaxa. According to the U.S. Food and Drug Administration (FDA), there were more than 800 reports of problems with Pradaxa. Of those more than 500 involved excessive bleeding and 117 involved fatalities. It is the responsibility of drug manufacturers to ensure that their products are properly tested before they are put on the market. Anyone who has suffered serious side effects as a result of taking Pradaxa or anyone who has lost a loved one as a result of Pradaxa side effects would be well advised to contact an experienced defective product lawyer who will fight for their rights and ensure that the negligent drug manufacturer is held liable.