Us Fda Recalls 7 000 Bottles Of Antidepressant Over Cancer Risk

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.

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 .