Thousands of bottles of a common antidepressant have been pulled from shelves after they were found to contain a cancer-causing chemical.
The FDA announced that more than 7,000 vials of duloxetine were recalled earlier this month after discovering that they contained high levels of N-nitroso-duloxetine.
The chemical is an impurity that occurs in the medication, which is sold under the brand name Cymbalta, during manufacturing. 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 an increased risk of cancer.
Patients are urged to consult with their doctors before stopping the medication 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 carcinogenic chemical (file image).
Cymbalta is a selective serotonin reuptake inhibitor (SSRI) that has been prescribed to about 18 million Americans for depression, anxiety, and nerve pain.
The recall includes 20-milligram tablets in 500-count bottles manufactured by Spain-based Towa Pharmaceutical Europe.
No illnesses have been reported. However, patients concerned about the presence of N-nitroso-duloxetine are urged to talk to their doctors before stopping taking the medications.
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 suffer withdrawal symptoms such as mood swings, aches, chills, and fatigue.
The FDA gave the recall a “Class II” designation, meaning the products could cause “temporary or medically reversible adverse health consequences,” 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, at higher concentrations and with prolonged exposure, nitrosamines may increase the risk of cancer of the throat, stomach, lung, brain, kidney, and bladder.
The FDA said in a statement: “There are multiple reasons why nitrosamines may be present in medications.
‘The FDA found that the source of nitrosamines may be related to the manufacturing process of the drug or its chemical structure or even the conditions in which it is stored or packaged.
“As the body processes food and medications, nitrosamines can also be formed. The FDA continues to test and investigate possible sources of medications containing nitrosamines.
It is not clear exactly how much N-nitroso-duloxetine the affected capsules contained.
The FDA said patients taking prescription drugs with “possible nitrosamine impurities” should talk to their doctor before stopping them.