Aborted Pradaxa Clinical Trial Prompts New Usage Warning From the FDA

Posted on December 20, 2012

The safety of Pradaxa has been called into question again, this time in situations where the drug is given to people who have a mechanical heart valve.

The Food and Drug Administration issued the warning following the results of an aborted clinical trial taking place in Europe.  That trial was brought to a halt once it was discovered that persons who had mechanical heart valves implanted were more susceptible to blood clots, strokes, or heart attacks when taking Pradaxa.  Users of Pradaxa also tended to experience excessive bleeding upon valve surgery in levels higher than those persons who only took warfarin.

Pradaxa is a popular blood thinner often prescribed to people who suffer from a condition known as non-valvular atrial fibrillation.  This typically entails an irregular heart rhythm that could make an individual experience a blood clot or a stroke.  Pradaxa is not, however, supposed to be used to treat the atrial fibrillation condition if that condition stems from issues with the heart valve.

Because of the risks that became apparent during the clinical trials, the FDA is telling doctors to switch Pradaxa patients who also have heart valves over to a different type of medication.  Patients with heart valves are being asked to speak with their doctors as soon as possible to alight upon a suitable corrective measure that can mitigate the risks. However, until such time that such persons can reach their doctors, they should not cease taking Pradaxa, as sudden stoppage can also increase the risk of an injury.

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