Urgent recall for antidepressants taken by millions after it was found to contain a carcinogen
A popular antidepressant taken by millions of people has been recalled after the pills were found to contain a carcinogen used in rocket fuel.
The FDA announced that more than 233,003 bottles of duloxetine had been recalled on November 19 after the capsules were found to contain high levels of N-nitroso-duloxetine.
The chemical is an impurity created during production. 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 several types of cancer.
New Jersey-based distributor Rising Pharmaceutical issued the recall of the compromised products, including 30-pill, 90-pill and 1,000-pill bottles of 60 mg duloxetine capsules.
The risk level of the recall is classified as ‘Class II’, meaning that ‘it may cause temporary or medically reversible adverse health effects.’
Patients are urged to consult their doctor before stopping the drug due to the risk of side effects if they suddenly stop taking the drug.
The FDA announced that more than 233,003 bottles of duloxetine were recalled on November 19 after the capsules were found to contain high levels of N-nitroso-duloxetine.
Stopping an antidepressant suddenly causes a sudden stop in 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.
Duloxetine belongs to a group of medicines called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs).
These medications are believed to work by increasing the activity of brain chemicals called serotonin and norepinephrine.
More than 23 million people in America are prescribed duloxetine every year 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 approximately 18 million Americans for depression, anxiety and nerve pain.
That recall included more than 7,000 bottles of 20-milligram tablets manufactured by Towa Pharmaceutical Europe, based in Spain.
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, 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 of medications containing 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.