What’s Behind the FDA’s Recent Duloxetine Capsule Recall?

The FDA has embarked on a critical recall of duloxetine capsules, stirring concerns over potential health risks.

At a Glance

The FDA recalled 7,107 bottles of duloxetine due to nitrosamine contamination.
Duloxetine treats depression, anxiety, and is sold as Cymbalta.
The recall is due to N-nitroso-duloxetine levels exceeding safe limits.
The recall, classified as Class II, suggests potential but non-serious health risks.

FDA’s Recall Details

The FDA announced a voluntary recall of over 7,000 bottles of duloxetine delayed-release capsules due to contamination with the chemical compound N-nitroso-duloxetine. The recall involved capsules sold in 500-count bottles with a 20 mg strength, and affected lot number 220128, carrying an expiration date of December 2024. Breckenridge Pharmaceutical, in charge of this recall, initiated the process due to levels of N-nitroso-duloxetine exceeding accepted safety limits.

Those staying informed about medication safety should note duloxetine, commonly sold as Cymbalta, serves patients suffering from depression, anxiety, and neuropathic pain. With the presence of the toxic impurity N-nitroso-duloxetine, patients and healthcare professionals must remain vigilant in ensuring continued safe use of medications.

The FDA has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can potentially cause cancer. https://t.co/XeKh5pfZI0

— TODAY (@TODAYshow) October 26, 2024

Class II Recall and Health Implication

The FDA labeled this recall a Class II, meaning consumption of the affected medication could lead to temporary or reversible adverse health effects, but the probability of severe consequences remains remote. Patients currently using duloxetine should engage with their healthcare providers to verify if their medication is part of this recall, and to discuss possible alternative treatments or unaffected supplies available.

“FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs. If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer.” – FDA

The nitrosamine group of impurities, to which N-nitroso-duloxetine belongs, poses a cancer risk if exposure surpasses permissible levels for extended durations. This has prompted recalls across several drug categories in recent years, stressing a need for awareness and caution.

The #FDA has recalled over 7000 bottles of duloxetine (Cymbalta), a medication used to treat mental health conditions such as #depression and anxiety, due to the presence of nitrosamine substance impurity.

Read more: https://t.co/r9A3meeoKM

— Pharmacy Times (@Pharmacy_Times) October 26, 2024

Actions for Patients and Healthcare Providers

Healthcare providers bear the responsibility of informing patients about alternative treatments for duloxetine and dealing with glycerin-exposed medications appropriately. The FDA does not offer specific guidance on dealing with recalled duloxetine, but stresses consultation with pharmacies and healthcare professionals for safety. Pharmacists play a crucial role in ensuring the availability of unaffected duloxetine lots, safeguarding uninterrupted treatment.

Nitrosamine impurities give rise to growing health awareness within the pharmaceutical industry. On October 10, this significant recall began, reminding patients of the importance of verified safety in medication use backed by attentive healthcare professionals.