A popular antidepressant taken by millions has been recalled after the pills were found to contain cancer chemical used in rocket fuel.
The FDA announced that more than 233,003 bottles of duloxetine were recalled on November 19 after finding the capsules contained high levels of N-nitroso-duloxetine.
The chemical is an impurity that occurs in the during manufacturing. However, it’s 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 multiple types of cancers.
New Jersey-based distributor Rising Pharmaceutical has issued the recall with the compromised products including 30-pill, 90-pilland 1,000-pillbottles of 60 mg duloxetine capsules.
The risk level of the recall has been classified as a ‘Class II’, meaning ‘it may cause temporary or medically reversible adverse health consequences.’
Patients are being urged to consult with their doctors before stopping the drug due to the risk of side effects of suddenly quitting the medication.
The FDA announced that more than 233,003 bottles of duloxetine were recalled on November 19 after finding the capsules contained high levels of N-nitroso-duloxetine
Suddenly stopping an antidepressant causes a sudden stop in levels of the hormone serotonin.
As the body doesn’t have enough time to adjust, patients could suffer withdrawal symptoms such as mood swings, aches, pains, chills, and fatigue.
Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs).
These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.
More than 23 million people in America are prescribed duloxetine to treat depression and anxiety each year.
The recall from Rising Pharmaceutical 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 18million Americans for depression, anxiety, and nerve pain.
That recall included more than 7,000 bottles of 20-milligram tablets manufactured by Towa Pharmaceutical Europe, which is 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 may increase the risk of throat, stomach, lung, brain, kidney, and bladder cancers.
The FDA said in a statement: ‘There are multiple reasons why nitrosamines can be present in drugs.
‘FDA found the source of nitrosamines can 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 drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.’
It’s unclear exactly how much N-nitroso-duloxetine the affected capsules contained.
The FDA said that patients taking prescription medications with ‘potential nitrosamine impurities’ should speak with their doctor before stopping the medications.
