Thousands of bottles of a commonly prescribed antidepressant drug have been recalled by the FDA because they were found to contain a suspected cancer-causing chemical.
Over 7,100 bottles of Duloxetine, sold under the brand name Cymbalta, were voluntarily recalled after the toxic chemical N-nitroso-duloxetine was found, the Food and Drug Administration announced.
The drug, manufactured by Spain-based Towa Pharmaceutical Europe, is a serotonin-norepinephrine reuptake inhibitor (SNRI) commonly prescribed for anxiety and depression, and used for pain caused by diabetes-related nerve damage.
Duloxetine is also used to treat fibromyalgia and chronic pain that is related to muscles and bones, according to the Mayo Clinic.
During its production, low levels of a chemical called N-nitroso-duloxetine can be produced, according to Newsweek.
When nitrosamines are present in higher concentrations, and people are exposed to it for an extended period of time, there’s an increased risk for cancer development, leading the FDA to strictly limit the concentrations.
“There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in a statement according to the outlet. “As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”
Towa issued the recall for 7,107 bottles, which covers 500-count bottles of 20mg Duloxetine Delayed-Release Capsules, Lot number: 220128, Exp. Date 12/2024, according to the Oct. 11 Class II recall.
The tainted bottles were distributed throughout the US.
A Class II recall is issued when “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 “recommends patients talk to their health care professional about the best course of action for their health if they have a medication that has been recalled,” the administration told CBS Moneywatch.
Immediately stopping duloxetine can cause withdrawal side effects with short-term effects appearing in as little as a few hours and lasting for up to 6 weeks, according to Healthline.
Tapering off antidepressant use depends on how long a patient has been taking the drug, with health officials recommending a four-week period of dose reduction.
