On December 19, 2012, the FDA released a statement that outlined new safety guidelines for the anticoagulant medication Pradaxa (dabigatran etexilate). According to a recent clinical trial, Pradaxa is contraindicated in patients with mechanical heart valves for the prevention of stroke or blood clots. The FDA required that the new label warn against the use of Pradaxa in this patient population, and that health care providers transition such patients to another medication. The FDA stated that they cannot recommend the use of Pradaxa in patients with valve replacements composed of natural biological tissue, and that patients with any kind of heart valve replacement are urged to discuss alternate treatment options with their health care provider.
The European RE-ALIGN trial consisted of patients who had recently undergone, or more than 3 months prior had undergone, bileaflet mechanical prosthetic heart valve implant surgery. The trial was halted before completion due to higher rates of stroke, heart attack, blood clot formation upon heart valves, and bleeding post-valve surgery in patients on Pradaxa compared to participants who were given warfarin (Coumadin).
The FDA previously released a safety statement regarding bleeding risk in patients prescribed Pradaxa. The association has not changed its recommendations for the use of Pradaxa in the patient group it is approved for, which are individuals with non-valvular atrial fibrillation.
Analysis:
Pradaxa (dabigatran etexilate) is an oral blood-thinning medicine used to prevent stroke and blood clots in patients with atrial fibrillation. Pradaxa was approved October 19, 2010 and is manufactured by Boehringer Ingelheim. Pradaxa has been reported to cause abnormal bleeding.
FAERS data (from 11/01/1997 to 06/30/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 17,980 serious adverse events which listed Pradaxa as a suspect drug, while 17,254 of these reports listed Pradaxa as the primary suspect. We identified 1,477 case reports which listed Pradaxa as the primary suspect associated with thromboembolic events and major bleeding.
The most commonly reported side effects were gastrointestinal hemorrhage, dyspepsia, and hemorrhage. We identified 6,249 hospitalizations and 1,847 patient deaths where Pradaxa was determined to be the primary suspect.
Note: In order to calculate the number of case reports involving thromboembolic events or major bleeding, we aggregated cases reporting the following adverse events: MedDRA low–level term: Pericardial effusion malignant, pericardial effusion. MedDRA preferred term: Acute myocardial infarction, cerebrovascular accident, myocardial infarction, post procedural myocardial infarction, and thrombosis. MedDRA high-level group term: gastrointestinal haemorrhages NEC; ocular haemorrhages and vascular disorders NEC; retina, choroid and vitreous haemorrhages and vascular disorders.
