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

Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

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 above 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.

And several weeks ago, Sun Pharmaceuticals said it is voluntarily recalling diltiazem hydrochloride in a 360-milligram dosage form across the United States. Diltiazem hydrochloride is used to treat chest pain, high blood pressure, and some heart rhythm disorders like atrial fibrillation or rapid heartbeats.

According to an FDA state, the recall was initiated after a “failed impurity specification” occurred during testing at an FDA facility. The drug was manufactured at Sun’s facility in Halol, India, and the company voluntarily initiated the recall, the notice said.

The drug agency also gave the recall its Class II designation, which means it is a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA website says.

Since 2018, a range of medications has been recalled due to nitrosamines, including valsartan, losartan, irbesartan, nizatidine, metformin, Zantac, Chantix, rifampin, and quinapril. In those recalls, consumers were generally advised not to stop taking their medication, although some suggested considering using another over-the-counter product for their condition, if applicable.

The FDA notes on its website that nitrosamines are common in water and foods, including in grilled and cured meats, dairy products, and some vegetables. Nitrosamine impurities could increase the risk of cancer if individuals are exposed to them above acceptable levels over a lengthy period of time, it says.

“FDA does not expect nitrosamines to cause harm when ingested at low levels. Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” its website said.