Millions of people are using an antidepressant that has been recalled immediately after it was discovered to contain a component that causes cancer. |
N-nitroso-duloxetine has been associated with an increased risk of several cancer types. Rising Pharmaceutical, a distributor in New Jersey, has recalled a number of compromised items, including 30-, 90-, and 1,000-pill packages of 60 mg duloxetine capsules. There is a "Class II" risk rating associated with the recall, which means that "it may cause temporary or medically reversible adverse health consequences." Because abruptly stopping a medicine can have negative side effects, patients are advised to speak with their doctors before doing so.
When an antidepressant is abruptly stopped, serotonin levels also abruptly stop. Because the body doesn't have enough time to acclimatise, patients may experience withdrawal symptoms like weariness, chills, aches, and pains, as well as mood fluctuations.The drug duloxetine is a member of the class of medications called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These drugs are believed to function by boosting the brain's production of neurotransmitters called serotonin and norepinephrine. Every year, more than 23 million Americans receive prescriptions for duloxetine to treat anxiety and depression.
Rising Pharmaceutical's recall follows another duloxetine batch, marketed under the Cymbalta brand, being recalled in October for the same reason. Regarding depression, anxiety, and nerve pain, around 18 million Americans have been administered Cymbalta. In that recall, Towa Pharmaceutical Europe, a Spanish company, produced over 7,000 bottles of 20-milligram tablets. There are no reported illnesses.
A class of compounds known as nitrosamines, which are frequently present in food and water products, includes N-nitroso-duloxetine. Higher levels and prolonged exposure to nitrosamines, however, may raise the risk of malignancies of the throat, stomach, lungs, brain, kidney, and bladder.
Nitrosamines can be found in medications for a variety of reasons, according to a statement from the FDA. The FDA discovered that the chemical makeup, manufacturing process, or even the packaging or storage circumstances of the drug may be connected to the source of nitrosamines. Nitrosamines can be produced as a result of the body's processing of meals and medications.
For medications confirmed to contain nitrosamines, the FDA is still testing and investigating potential sources. How much N-nitroso-duloxetine was in the impacted capsules is unknown.Before quitting prescription drugs that include "potential nitrosamine impurities," patients should see their doctor, according to the FDA.
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