The United States Food and Drug Administration (FDA) has recalled over 7 000 bottles of the duloxetine antidepressant drug known as Cymbalta after levels of N-nitroso-duloxetine were detected, Cape {town} Etc reports.
N-nitroso-duloxetine is a chemical that is known to increase the risk of cancer, with the Class II recall of the drug being initiated on 10 October and currently ongoing.
A Class II recall has been described as ‘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,’ according to the FDA.
Also read: Instant porridge recalled following death of three toddlers
While N-nitroso-duloxetine was already present in the drug, the levels of the chemical were above the proposed interim limit.
Nitrosamines are common in food and water, with exposure to some levels of the chemical being common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, according to the FDA.
Duloxetine (Cymbalta) is a ‘serotonin-norepinephrine reuptake’ inhibitor that is primarily used to treat depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain and neuropathic pain associated with diabetic peripheral neuropathy, according to Medscape.
Bottles that were recalled contained the lot number 220128, with an expiration date of December 2024. Each bottle contains 500 delayed-release 20-milligram capsules.
No other formulations of the drug are reported to have been affected, according to WebMD.
Also read:
Update: Factory failures linked to listeria in hummus recall
Picture: Pietro Jeng / Pexels