Australian Regulatory Authority Issued Advisory
Back in 2011 the TGA, an Australian regulatory authority, issued a “safety advisory” for the oral anticoagulant dabigatran (Pradaxa) because of an increase in the number of bleeding-related adverse event reports received once the drug indications were expanded to include the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Pradaxa was first approved in Australia in 2009 for the prevention of venous thromboembolic events (blood clots) in patients who had undergone major orthopedic surgery of the lower limb.
According to a MedScape report, in April 2011, the indications were expanded to include the prevention of stroke and systemic embolism in patients with atrial fibrillation.
This led to a significant increase in reports of gastrointestinal and intracranial bleeding and prompted the current safety advisory.
Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).
According to the FDA, from October 2010 through January 2011, approximately 128,000 Pradaxa prescriptions were dispensed and approximately 86,000 patients filled Pradaxa prescriptions from the outpatient retail pharmacies in the U.S.
Fatal bleeding is among the most common adverse reactions reported by patients treated with Pradaxa, according to the FDA. Other side-effects include gastrointestinal symptoms, stomach pain, nausea, heartburn, and bloating.