With its new Drug Safety Communication Notification, the FDA has informed doctors, health care professionals and common people that anti-coagulant drug; Pradaxa (dabigatran) should not be used in people with mechanical heart valves.

The safety notification was issued by the agency on the basis of findings that appeared from the RE-ALIGN clinical trial which revealed that when participants with mechanical heart valves were administered with the blood thinner “Pradaxa” they began experiencing strokes and heart attacks. The clinical trial also revealed that the rate of blood clot formation had also gone up. There was also a higher incidence of bleeding after valve surgery in those using Pradaxa.

According to reports the clinical trial was sponsored by the manufacturer of Pradaxa, Boehringer Ingelheim, however, the drug giant had to stop the trial prematurely when participants with mechanical heart valves using Pradaxa began experiencing various side effects and complications like heart attacks, blood clots and strokes.

The trial included 400 patients with mechanical heart valves and was supposed to continue for a period of 12 weeks. Boehringer was quick to defend the drug’s safety profile. Forbes quoted the drug maker as saying that the RE-ALIGN news does not “affect the positive benefit/risk profile of Pradaxa 150 mg for the current labeled indication” and that “RE-ALIGN is evaluating a different patient population.”

According to reports from the agency, the company will be sending Direct Healthcare Professional Communication (DHPC) – also known as a “Dear Doctor Letter” to doctors and health care professionals to inform them about the decision of the FDA about the drug. With the letter the manufacturer of the drug, Boehringer Ingelheim will inform doctors and healthcare professionals that Pradaxa is contraindicated in patients with mechanical heart valves.

What is Pradaxa?

Pradaxa is an anti-coagulant, produced, manufactured and marketed by pharmaceuticals giant Boehringer Ingelheim and indicated for the condition of excessive bleeding in various parts of the body. The drug was widely recognized and considered as an effective alternative to Warfarin.

 

Some Side Effects of Pradaxa

  • Continuous and non-stop bleeding
  • Passing black or tarry stools
  • Passing blood in urine or stool
  • Weakness
  • Unusual bleeding through various parts of the body like mouth, nose, vagina
  • Vomiting and coughing up blood
  • Pain in bones and joints
  • Appearance of red or purple spots under the skin
  • Heavy menstrual bleeding