More than 7,000 bottles of the duoxetine antidepressant drug Cymbalta, have been removed from shelves after the U.S. Food and Drug Administration (FDA) detected elevated levels of N-nitroso-duloxetine, a chemical known to increase cancer risk.
N-nitroso-duloxetine forms during the drug’s manufacturing process and belongs to the nitrosamines group, chemicals which are present in water, foods, pesticides, and even rocket fuel.
While low levels of nitrosamines are generally safe, prolonged exposure to high levels has been linked to an increased risk of cancers, including those of the throat, stomach, lungs, brain, kidneys, and bladder.
Cymbalta, classified as a selective serotonin reuptake inhibitor (SSRI), is prescribed for depression, anxiety, and nerve pain.
The recall is for 20-milligram tablets packaged in 500-count bottles, produced by Towa Pharmaceutical Europe, a Spanish-based manufacturer.
The FDA has categorised the recall as “Class II,” indicating that while adverse health effects are possible, they are typically temporary or reversible and do not usually result in severe health outcomes or death.
In a statement, the FDA explained that nitrosamines may appear in medications for various reasons, often tied to the manufacturing process, the chemical structure of the drug, or storage conditions.
They can also form as food and drugs break down in the body. The FDA is continuing to investigate and test affected medications to ensure safety for consumers.
The exact quantity of N-nitroso-duloxetine in the recalled bottles remains unknown.
South Africans using duloxetine or Cymbalta can consult their pharmacists to discuss any concerns, particularly regarding nitrosamine exposure, and explore safe alternatives if needed.
The drug is distributed in South Africa through the medical company Eli Lilly.
IOL Lifestyle