The Food and Drug Administration (FDA) issued a reminder reviews for thousands of bottles of antidepressant duloxetine due to the presence of nitrosamines, a carcinogenic chemical.

Duloxetine is a common antidepressant sold under the brand name Cymbalta. It belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors (SNRIs) which are used to treat depression and anxiety.

Drugmaker Towa Pharmaceutical Europe has recalled more than 7,000 bottles of duloxetine 20 mg delayed-release capsules 500 mg, distributed nationwide.

The recall began on October 10 as a Class II recall, meaning the product could “cause temporary or medically reversible adverse health effects” and is unlikely to cause serious harm to health. health.

What are nitrosamines?

According to the FDA, nitrosamines are organic compounds found in low amounts in water and foods, including meat, dairy products and vegetables. “Everyone is exposed to some level of nitrosamines,” the agency said.

The FDA states that if a person is exposed to nitrosamines at or below the safe level daily for 70 years, they may not be at increased risk of cancer. However, prolonged exposure to higher levels may increase the risk of cancer.

The specific nitrosamine detected in Towa duloxetine is called N-nitroso-duloxetine. Nitrosamines can form during chemical reactions during the drug manufacturing process and during its packaging and storage.

These contaminants have led to the recall of several medications, including the heartburn drug Zantac, the diabetes drug metformin, and the smoking cessation aid Chantix.

What to do if you take duloxetine

You can check if your medicine was in the affected lot. The recall concerns lot #220128, which expires 12/2024.

If you are concerned that your medications may be contaminated, call your pharmacy. Pharmacists can tell you if your lot is part of the recalled lot and what your options are. They may be able to issue duloxetine which is not part of the recall.

The FDA has advised not to suddenly stop taking your medications without first consulting your healthcare professional. The risks of stopping treatment “may exceed the potential risk of exposure to nitrosamines.”