
More than 7,000 bottles of the antidepressant duloxetine have been recalled by the FDA due to a potentially dangerous chemical.
At a Glance
- The FDA has recalled over 7,100 duloxetine bottles for toxic chemical presence.
- Effects may include potential cancer risk due to N-nitroso-duloxetine.
- The recall targets specific lots of duloxetine capsules.
- Healthcare providers advise caution and communication with professionals.
Reason for the Recall
A recent recall affects over 7,100 bottles of duloxetine due to the presence of N-nitroso-duloxetine, a toxic chemical linked to cancer. It’s present at levels above the interim limit, prompting urgent action from the FDA. Such impurities can arise from manufacturing processes, chemical structures, or storage conditions. The recall involves specific dosage forms of duloxetine, known by the brand name Cymbalta, employed to treat depression, anxiety, and mood disorders.
The recall has been classified as Class II, meaning it has the potential to cause adverse health consequences that are either temporary or reversible. The probability of serious health risks remains remote. Due to these concerns, healthcare providers and pharmacists have been instructed to halt distribution of affected lots.
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
Scope of the Recall
The recalled lot, numbered 220128 and set to expire in December 2024, includes 20mg, 30mg, and 60mg delayed-release capsules. Manufactured by Towa Pharmaceutical Europe and distributed by Breckenridge Pharmaceutical, these organizations have not issued public comments but are collaborating with the FDA to implement the recall.
“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA said.
For patients in possession of these bottles, the FDA has advised consulting healthcare providers for medical advice and alternative treatment options. While patient safety remains paramount, the sudden recall without specific disposal instructions leaves the decision-making in the hands of patients and professionals.
What Steps to Take
The FDA has not given specific guidance on handling these recalled bottles. Patients are advised not to panic, but to reach out to their doctors for more information and updates. Healthcare professionals have been instructed to help patients transition to safe and effective alternatives, as they assess the impact of N-nitroso-duloxetine and its role in other recalls across various medications.
The FDA cites similar recalls due to nitrosamine impurities in recent years across different medications, including oral anticoagulants and metformin. As the agency stresses, the importance of continuing necessary medication might overshadow the risks associated with these impurities, weighing the immediate health needs against the potential risk of exposure.
Sources
- FDA Announces Recall of More the 7000 Bottles of Duloxetine
- FDA recalls more than 7,000 bottles of antidepressant duloxetine over toxic chemical
- FDA recalls thousands of antidepressant bottles due to cancer-causing chemical
- FDA recalls over 7,000 bottles of antidepressant duloxetine