Over 8 million U.S. adults take antidepressants to treat mild to moderate depression, anxiety and, in some cases, chronic pain. A recent Food and Drug Administration (FDA) recall of a commonly prescribed antidepressant, Duloxetine, because it may contain a potentially cancer-causing agent that could impact the health of those taking the drug. Keep reading to determine if this recall affects you and how the FDA plans to navigate pharmaceutical safety.
FDA Duloxetine recall: contamination with cancer-causing agent
The FDA issued a Class II recall on the antidepressant Duloxetine because it may contain N-nitroso-duloxetine, a known carcinogen.
The FDA-issued recall followed a voluntary recall of the product by its distributor on Nov. 19.
A Class II FDA recall indicates that “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences,” according to the FDA’s website.
Though the recall states that the probability of serious adverse health consequences is remote, swallowing N-nitroso-duloxetine is toxic for humans and suspected to cause cancer.
The recall affected over 233,003 30-count, 90-count and 1,000-count bottles of 60 mg Duloxetine capsules.
The FDA does not suggest that patients stop taking Duloxetine immediately but instead talk to their healthcare provider to determine a definitive and safe solution.
If you have been prescribed Duloxetine and aren’t sure whether or not your prescription was impacted, ask your pharmacist if your bottle is included in the recall.
What you need to know about the Duloxetine antidepressant recall
Duloxetine is a special type of drug called an SNRI or serotonin/norepinephrine reuptake inhibitor.
This class of drugs works by altering communication in brain nerve cell circuitry that helps to regulate our moods.
SNRIs like Duloxetine are prescribed chiefly to treat major depressive disorder (MDD) but can also be effective in treating anxiety, post-traumatic stress disorder (PTSD) and even chronic pain such as diabetic neuropathy and fibromyalgia.
Duloxetine is the generic version of the brand-name drug Cymbalta.
What Is N-nitroso-duloxetine, the cancer-causing agent in Duloxetine?
Duloxetine was recalled for containing N-nitroso-duloxetine. This chemical compound includes nitrosamine, a substance known to cause cancer.
Nitrosamines are organic compounds that—despite being carcinogenic—we are exposed to at low levels on a day-to-day basis.
Nitrosamines exist in our water and food and, in the case of Duloxetine, they often form via chemical reactions that occur during the manufacturing of a drug.
Low levels of nitrosamine exposure are not dangerous for healthy humans; however, the FDA has set limits on how much may be present in medications.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the FDA says about nitrosamine impurities in medications. “A person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”
What to do if you’ve been prescribed Duloxetine?
If you’re currently taking Duloxetine, the FDA advises against stopping the medication abruptly.
Not only can a sudden discontinuation of a medication lead to dangerous withdrawal symptoms, it can also result in a resurgence of the condition it was prescribed to treat.
What should you do? Contact your healthcare provider as soon as possible. Together, you can assess your specific prescription to determine whether it’s part of the recall and recommend an appropriate alternative if necessary.
Your pharmacist is also a tremendous resource in these situations. Simply take your prescription to your local pharmacy to verify whether or not your bottle is affected by the recall.
Taking these precautions alongside medical and healthcare professionals ensures your safety while maintaining your mental and physical health.
