FDA Notice: Common Stroke Medication Recalled Over Cancer-Causing Chemical

Authored by Jack Phillips via The Epoch Times (emphasis ours),

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 connection 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.”

Dabigatran etexilate is a prescription medication that is used to lower the risk of stroke and blood clots in some individuals, according to the National Libraries of Medicine. Specifically, the drug is used to treat deep vein thrombosis, to prevent strokes or serious blood clots in individuals with atrial fibrillation, and pulmonary embolism in both children and adults.

The company said that the recalled medication was distributed around the United States between June 2022 and October 2022. Lot numbers and other information about the recalled product are available on the FDA’s website.

“Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment,” the notice said. “Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information.”

But consumers should contact their doctor if they’ve experienced any adverse health events associated with the medication, the notice said.

Other Recalls

In October, Aurobindo Pharma USA announced the voluntary recall of two lots of blood pressure medication because of high levels of nitrosamine, according to an FDA notice. Two months later, Lupin Pharmaceuticals Inc. stated that it is voluntarily recalling four lots of Quinapril tablets due to the presence of nitrosamine.

Read more here…