Oct. 25, 2024 – Thousands of bottles of the medicine duloxetine are being recalled because they may contain a potentially cancer-causing agent.
Duloxetine is the generic equivalent of the drug marketed as Cymbalta, which is approved to treat depression, anxiety, fibromyalgia, chronic muscle and joint pain, and pain from nerve damage in people with diabetes. The FDA advises that people not stop taking duloxetine, but instead first discuss the matter with their health care professional.
The recall was voluntary and started by drugmaker Towa Pharmaceutical, according to the FDA's announcement. A total of 7,107 bottles are affected, with lot number 220128 and an expiration date of 12/2024. Each bottle contains 500 delayed-release 20-milligram capsules. No other formulations of the drug are affected. People who take duloxetine may ask their pharmacist if their particular bottle is included in the recall.
The capsules may contain a chemical compound called N-nitroso-duloxetine – known to include the carcinogenic substance nitrosamine. The compound is toxic if swallowed and is suspected of causing cancer, according to the National Institutes of Health.
Although everyone is exposed to some level of nitrosamines because they are common in water and foods, the FDA has set limits on how much may be present in medications.
This is a Class II recall, a mid-level designation the FDA uses to communicate how hazardous a recalled product may be to a person’s health. Class II indicates that a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the agency’s definition states.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA’s webpage on the impurities explains.
Numerous drugs have been recalled in recent years over nitrosamine impurities, including metformin, ranitidine (Zantac), and varenicline (Chantix).
Pharmacists at the FDA’s Division of Drug Information are available to answer questions and may be reached by emailing [email protected] or by calling 855-543-DRUG (855-543-3784) or 301-796-3400.
The FDA urges people to keep taking their medicine until they have spoken to a health care professional because “the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines. The FDA and the international scientific community do not expect nitrosamines to cause harm when ingested at low levels,” according to the agency’s webpage titled “What to Know and Do About Possible Nitrosamines in Your Medication.”
