Important points
- The FDA has issued a recall notice for more than 7,000 bottles of duloxetine, which is used to treat depression, anxiety, and nerve pain.
- The recalled lots may contain high levels of nitrosamines, which are carcinogenic compounds.
- This recall is Class II, meaning that the health effects associated with ingesting contaminated medicines are likely to be temporary or medically reversible, and are unlikely to cause serious health effects.
Food and Drug Administration (FDA) A recall has been issued Notification about thousands of bottles of antidepressants duloxetine This is due to the presence of nitrosamines, which are carcinogenic chemicals.
Duloxetine is a common antidepressant sold under the brand name Cymbalta. It belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors (SNRIs) that are used to treat depression and anxiety.
Pharmaceutical company Towa Pharmaceutical Europe has recalled more than 7,000 bottles of 500-count, 20 mg duloxetine delayed-release capsules that were distributed nationwide.
The recall began Oct. 10 as a Class II recall, stating that the product “may cause temporary or medically reversible adverse health effects,” but may cause serious adverse health effects. gender means low.
What are nitrosamines?
According to the FDA, nitrosamines are organic compounds that are present in low concentrations in water and foods such as meat, dairy products, and vegetables. “Everyone is exposed to some degree of nitrosamines,” the agency said.
The FDA says daily exposure to sub-safety nitrosamines for 70 years may not increase the risk of cancer. However, long-term exposure to higher levels may increase the risk of cancer.
The specific nitrosamine detected in TOWA’s duloxetine is called N-nitroso-duloxetine. Nitrosamines can form during chemical reactions during pharmaceutical manufacturing processes and during packaging and storage.
These contaminants have led to recalls of several medicines, including the heartburn drug Zantac, the diabetes drug Metformin, and the smoking cessation aid Chantix.
What to do if you take duloxetine
You can check if your medicine is in an affected batch. The recall is for lot #220128, which expires in December 2024.
If you are concerned that your medicine may be contaminated, contact your pharmacy. Your pharmacist will tell you if your batch is part of a recalled lot and what your options are. It is possible that duloxetine, which is not included in the recall, can be dispensed.
The FDA warned people not to suddenly stop taking the drug without first talking to their health care provider. The risks of discontinuing the medication “may outweigh the potential risks of exposure to nitrosamines.”
what this means to you
If you have further questions about the safety of duloxetine or other drugs, please contact the FDA. Pharmaceutical Information Division Or contact your pharmacy or health care provider.
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