A popular antidepressant taken by millions of people has been pulled from the market after the pills were found to contain a carcinogenic chemical used in rocket fuel.
The FDA announced that more than 233,003 vials of duloxetine were recalled on November 19 after discovering that the capsules contained high levels of N-nitroso-duloxetine.
The chemical is an impurity that is produced 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 multiple types of cancer.
New Jersey-based distributor Rising Pharmaceutical has issued the recall for the compromised products, including bottles of 30 pills, 90 pills, and 1,000 pills of duloxetine 60 mg capsules.
The risk level of the recall has been classified as “Class II,” meaning it “may cause temporary or medically reversible adverse health consequences.”
Patients are urged to consult with their doctors before stopping the medication due to the risk of side effects when stopping suddenly.
The FDA announced that more than 233,003 vials of duloxetine were recalled on November 19 after discovering that the capsules contained high levels of N-nitroso-duloxetine.
Stopping an antidepressant suddenly 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.
Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs).
These medications are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.
Each year, more than 23 million people in the United States are prescribed duloxetine to treat depression and anxiety.
Rising Pharmaceutical’s recall comes after another batch of duloxetine, sold under the brand name Cymbalta, was recalled in October for the same reason.
Cymbalta has been prescribed to about 18 million Americans for depression, anxiety and nerve pain.
That recall included more than 7,000 bottles of 20-milligram tablets manufactured by Spain-based Towa Pharmaceutical Europe.
No illnesses have been reported.
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 unclear exactly how much N-nitroso-duloxetine the affected capsules contained.
The FDA said patients taking prescription medications with “possible nitrosamine impurities” should talk to their doctor before stopping them.