Heart Drug Recall: FDA Says More Than 5,000 Scripts Removed
A national recall on three dosages of blood thinner has been issued by the FDA, with expiration dates into next year.
The National Blood Clot Alliance suggests that more than 8 million Americans take an anti-coagulant—a blood thinner—which may be indicated for patients managing conditions like arrhythmia, blood clots, heart attack, mechanical heart valve, or surgery recovery. Because of bleeding risk, these drugs are notoriously essential to manage. This week, the U.S. Food and Drug Administration (FDA) published a report on a generic drug that has been recalled for a quality issue. If you have a carton of dabigatran etexilate in your medicine cabinet, check the label. New Jersey-based Ascend Laboratories (distributed by Major Pharmaceuticals in Indiana and manufactured by Alkem Laboratories in India) is voluntarily recalling three lots of the drug. Dabigatran etexilate is a generic version of the blood thinner Pradaxa, commonly prescribed to prevent strokes and blood clots for individuals with atrial fibrillation. A reported 5,460 cartons of the drug have been affected by the recall, which was initiated after testing turned up more of the drug’s own breakdown byproducts than allowed. The recall was triggered by the discovery of elevated “impurities” beyond the approved threshold during routine long-term stability testing. The recalled products reportedly came in cartons containing blister packs with any of the following details: 150 milligrams (mg) capsules, 60-count: Lot 25141583, expiration April 2027; 60 mg capsules, 60-count: Lot 25141585, expiration April 2027; 75 mg capsules, 30-count: Lot 25141586, expiration April 2027. As of press time, the FDA had not reported on their ruling for the severity of health risk. If you have a prescription bottle with a matching lot number, check it immediately and call your pharmacist or doctor regarding a replacement. Dabigatran is a blood thinner, and abruptly quitting a blood thinner can present its own health risk. When in doubt, your pharmacist can look up the lot number for your prescription. For daily wellness updates, subscribe to The Healthy newsletter and follow The Healthy on Facebook, Instagram, and Google.