N-Nitroso-duloxetine is part of the nitrosamine chemical group and is commonly found in food and aquatic products. Multiple studies have shown that this chemical has the potential to cause cancer at high concentrations and with long-term exposure, which is why the FDA strictly regulates its limits.
Why do nitrosamines exist?
“There are many reasons why nitrosamines can be present in drugs,” the FDA said in a statement. “FDA has found that the source of nitrosamines may be related to the drug’s manufacturing process or its chemical structure, or even to the conditions in which the drug is stored or packaged.” To newsweek Regarding the Class II recall. “Nitrosamines also form when foods and drugs are processed in the body. The FDA continues to test and study possible sources of drugs containing nitrosamines.”
A Class II recall is the second most serious recall in the FDA’s recall classification system (Class I is the most serious and Class III is the least serious). The FDA said this indicates that the recalled products have the potential to cause “temporary or medically reversible adverse health consequences.”
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Are all duloxetine bottles recalled?
Won’t. The affected product has a lot number of 220128 and an expiration date of 12/2024. A total of 7,104 bottles are being recalled.
Duloxetine or Cymbalta belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). They work by increasing the activity of serotonin and norepinephrine, two substances that are known to play a role in regulating mood and pain.
These drugs are used to treat depression, anxiety, and sometimes nerve pain. Although SSNRIs are usually taken daily, it may take several weeks to see their therapeutic effects. Likewise, anyone who wants to stop taking an SSNRI is advised to do so gradually over 2 to 4 weeks, as quitting suddenly without gradually stopping the drug may cause withdrawal symptoms such as dizziness, nausea, and headaches.
What to do if your medicines are affected
Because of the withdrawal symptoms associated with SSNRIs, the FDA recommends that anyone taking the medication from the recalled batch consult their provider about next steps and not to stop taking the medication immediately.
