The U.S. Food and Drug Administration (FDA) announced the recall of a commonly used stroke medication after the company discovered the presence of a potentially cancer-causing impurity.
In an FDA-issued recall notice on March 22, Ascend Laboratories LLC said it is recalling Dabigatran Etcxilate Capsules at the consumer level after nitrosamine, a carcinogenic substance, was found about the “acceptable daily intake level.” The company said it hasn’t received any reports of adverse events or health problems in connected to the recall.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the FDA said. “The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.”…