Thousands of bottles of a widely used antidepressant have been pulled from shelves after they were found to contain a cancer-causing chemical.
The FDA announced earlier this month that more than 7,000 bottles of duloxetine had been recalled after they were found to contain high levels of N-nitroso-duloxetine.
The chemical is an impurity that occurs during manufacturing in the drug, which is sold under the brand name Cymbalta. However, it is part of a group of chemicals called nitrosamines, which are used in pesticides and rocket fuel.
N-nitroso-duloxetine has been linked to a higher risk of cancer.
Patients are urged to consult their doctor before stopping the drug due to the risk of side effects.
The FDA announced that 7,107 bottles of Duloxetine Delayed-Release Capsules – sold under the brand name Cymbalta – have been recalled because they contain a potentially cancer-causing chemical (stock image)
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Cymbalta is a selective serotonin reuptake inhibitor (SSRI) and has been prescribed to approximately 18 million Americans for depression, anxiety and nerve pain.
The recall includes 20-milligram tablets in bottles of 500 units manufactured by Towa Pharmaceutical Europe, based in Spain.
No illnesses have been reported. However, patients concerned about the presence of N-nitroso-duloxetine are urged to talk to their doctor before stopping the medication.
This is because suddenly stopping an SSRI causes a sudden stop in the levels of the hormone serotonin. Because the body does not have enough time to adapt, patients may experience withdrawal symptoms such as mood swings, pain, chills and fatigue.
The FDA gave the recall a “Class II” designation, meaning the products could cause “temporary or medically reversible adverse health effects” but not serious health problems or death.
N-nitroso-duloxetine belongs to a group of chemicals called nitrosamines, which are commonly found in water and food products.
However, in higher concentrations and with long-term exposure, nitrosamines can increase the risk of throat, stomach, lung, brain, kidney and bladder cancer.
The FDA said in a statement: “There are several reasons why nitrosamines may be present in medications.
‘FDA found that the source of nitrosamines may be related to the drug’s manufacturing process or its chemical structure, or even the conditions in which they are stored or packaged
‘As foods and medications are processed in the body, nitrosamines can also be formed. “The FDA continues to test and investigate possible sources for medications found to contain nitrosamines.”
It is unclear exactly how much N-nitroso-duloxetine the capsules in question contain.
The FDA said patients taking prescription medications with “potential nitrosamine impurities” should talk to their doctors before stopping the medications.