Depression patients should check their medications this week, as the widely prescribed drug Cymbalta has been pulled from the shelves by the FDA amid concerns that it contains a substance linked to cancer.
Drug maker Towa Pharmaceutical Europe faced a Class II recall by the Food and Drug Administration this week over their product Duloxetine, used to treat anxiety and depression in the US.
The FDA issued the warning on Thursday, October 10th. The recall affects 7,000 bottles the antidepressant nationwide. The agency reported that a “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine. Here’s everything you need to know:
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Antidepressant Linked To Cancer
The FDA issued an advisory that they had detected nitrosamine impurities in the affected Duloxetine batch.Nitrosamine impurities "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time," the agency wrote.
The issue seems to be only with extended intake of the medication. "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," they clarified.
Not All Products Affected
The recall only impacts bottles of 500-count delayed-release capsules with an expiration date of December 2024 and a lot number of 220128. Here are the full details of the recall.
This means that the medication itself has not been linked to cancer, and if you take the medication you will want to check the label to see if yours is affected.
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Should You Stop Taking Your Medication?
Harvard Medical School states that discontinuation symptoms can occur if antidepressant medications are withdrawn too quickly, and that patients should consult their doctors before they stop taking their prescribed medications.
The drugmaker issued a similar warning to patients, stating that information from the FDA that says that patients who have bottles of the recalled medicine should not stop taking it, and should first contact their doctor.
Should You Flush Your Drugs?
The FDA did not issue specific guidance on what to do with the recalled duloxetine pills, but they do have instructions for safe disposal of drugs on their websites. Duloxetine is not an opiod and does not appear on the FDA's "Flush List" of drugs that should be flushed down the toilet.
"The best option is to find a drug take-back location," they state in their promotional video on the topic. Here is more information.
Is Cymbalta Affected?
Duloxetine as sold under the brand name Cymbalta, but drugmakers assert that this specific brand is not included in the current recall.
A spokesperson for Cymbalta maker Eli Lilly has stated that the brand is "not affected and it is not the product being recalled."
