The U.S. Food and Drug Administration (FDA) has recalled over 7,000 bottles of duloxetine, a widely used antidepressant, due to the discovery of a potentially cancer-causing chemical.
The recall, initiated on October 10, involves Duloxetine Delayed-Release Capsules made by Towa Pharmaceutical Europe.
At the heart of the recall is the discovery of N-nitroso-duloxetine, a chemical impurity that exceeds the FDA’s safety limits. Nitrosamines, like N-nitroso-duloxetine, are known for their toxic properties when ingested and have been linked to cancer risks, according to the National Library of Medicine.
The FDA issued a public notice explaining that more than 7,100 bottles of duloxetine, including 500 delayed-release 20-milligram capsules, are subject to the recall. The affected capsules have a lot number of 220128 and an expiration date of December 2024.
This recall has been classified as a Class II, meaning that while the product may cause temporary or medically reversible adverse health effects, the likelihood of serious health consequences is considered remote.
Still, the FDA highlights the risks associated with nitrosamine impurities. Long-term exposure to these chemicals, especially in amounts above acceptable levels, can lead to an increased risk of cancer.
Nitrosamines, such as the N-nitroso-duloxetine found in these bottles, are not only present in medications but also in common foods like grilled meats, dairy products, and vegetables.
While everyone is exposed to some level of nitrosamines through daily consumption, the FDA has set strict guidelines for acceptable levels in medications due to the higher risk associated with long-term exposure.
The FDA continues to study the potential sources of nitrosamine contamination in drugs. Factors such as the drug’s manufacturing process, its chemical structure, and storage conditions can all contribute to the presence of these impurities.
Duloxetine is commonly prescribed for the treatment of depression and anxiety and is sold under brand names like Cymbalta. It is also used to manage pain linked to nerve damage, diabetes, and fibromyalgia.
The drug is part of a class of medications known as selective serotonin and norepinephrine reuptake inhibitors, which boost serotonin and norepinephrine levels in the brain to help improve mood and reduce pain.
While the recall has raised concerns about duloxetine’s safety, the FDA states that exposure to nitrosamines at low levels does not pose an immediate health risk.
However, the agency stresses that it is committed to further investigating the cause of this contamination and ensuring public safety.
As the FDA continues its research, patients who are taking duloxetine should consult their healthcare provider to discuss any concerns and explore alternative treatments if necessary.
The discovery of potentially cancer-causing chemicals in a widely-used antidepressant has raised alarm among healthcare providers and patients alike.
The recall of over 7,000 bottles reflects the FDA’s focus on protecting consumer safety. It also raises concerns about the need for ongoing checks on drug manufacturing and potential impurities that could affect public health.
For further details, the FDA advises reviewing the official recall notice or consulting with a healthcare professional.