Thousands of bottles of commonly prescribed antidepressants have been recalled by the FDA after they were found to contain chemicals suspected of causing cancer.
More than 7,100 bottles of duloxetine sold under the brand name Cymbalta were voluntarily recalled after the toxic chemical N-nitroso-duloxetine was discovered. Announced by the Food and Drug Administration.
The drug is a serotonin norepinephrine reuptake inhibitor (SNRI) manufactured by Spain-based Towa Pharmaceutical Europe S.A., and is commonly prescribed for anxiety and depression, which is caused by diabetes-related nerve damage. Used for pain.
Duloxetine is also used to treat fibromyalgia and chronic pain related to muscles and bones, according to the Mayo Clinic.
During its manufacture, low levels of a chemical called N-nitroso-duloxetine may be produced. According to Newsweek magazine.
When nitrosamines are present in high concentrations and people are exposed to them for long periods of time, they increase the risk of developing cancer, leading the FDA to severely limit their concentrations.
“There are multiple reasons why nitrosamines may be found in drugs. FDA has found that the source of nitrosamines can be related to the drug's manufacturing process and chemical structure, as well as its storage and packaging conditions.” the FDA said in a statement. “Nitrosamines can also be produced when foods and drugs are processed in the body. FDA continues to test and research potential sources of medications found to contain nitrosamines.”
Towa has issued a recall for 7,107 bottles. This is a 500 count bottle of 20mg Duloxetine Delayed Release Capsules, Lot Number: 220128, Exp. Date December 2024, per Class II recall dated October 11th.
Contaminated bottles were distributed throughout the United States.
Class II recalls are issued “when use or exposure to a violative product is likely to cause temporary or medically reversible health harm, or when the likelihood of serious health harm is remote.”
“If a drug has been recalled, the FDA recommends that patients consult their health care professional about the best course of action for their health.” he told CBS MoneyWatch.
Immediate discontinuation of duloxetine can result in short-term effects within a few hours and withdrawal side effects that can last up to 6 weeks. According to Healthline.
Tapering of antidepressants depends on how long a patient has been on the drug, with health authorities recommending a 4-week dose reduction.
