A recall has been issued for thousands of bottles of the medicine duloxetine because they may contain a potentially cancer-causing agent, according to the US Food & Drug Administration (FDA).
Duloxetine is the generic equivalent of Cymbalta, which is approved to treat depression, anxiety, fibromyalgia, chronic muscle and joint pain, and pain from nerve damage in people with diabetes.
The recall was voluntary and started by Towa Pharmaceutical, reports WebMD. 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 20mg 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, said 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 2 recall, a mid-level designation the FDA uses to communicate how hazardous a recalled product may be to a person’s health. Class 2 indicates that a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.
“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.”
Numerous drugs have been recalled in recent years over nitrosamine impurities, including metformin, ranitidine (Zantac), and varenicline (Chantix).
The FDA urges people to keep taking their medicine until they have spoken to a healthcare professional because “the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines”.
WebMD article – Over 7,000 Bottles of Antidepressant Recalled: What to Know (Open access)
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