Thousands of Antidepressant Bottles Recalled Due to Toxic Chemical
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of certain batches of duloxetine capsules, sold under the brand name Cymbalta.
The recall was initiated on October 10th, 2024 and stems from the presence of a potentially cancer-causing chemical exceeding acceptable limits.
What is Duloxetine and Cymbalta?
Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SSRI/SNRI) medication used to treat depression, anxiety disorders, and chronic pain conditions like fibromyalgia. It is marketed under the brand name Cymbalta by Eli Lilly and Company.
Details of the Recall
The recall includes specific batches of Cymbalta capsules containing levels of N-nitroso-duloxetine exceeding the FDA's safety threshold. N-nitroso-duloxetine is a nitrosamine, a class of chemicals linked to an increased risk of cancer in long-term exposure.
The recall covers specific batches of 500mg delayed-release duloxetine capsules, identified by the lot number 220128 and an expiration date of December 2024. Consumers are urged to check their medication bottles for this information.
Potential Risks for Patients
The FDA has classified the recall as Class II, indicating a potential for "temporary or medically reversible adverse health consequences." However, long-term use of medications containing excessive levels of nitrosamines raises concerns about an increased risk of cancer development.
If you have a bottle of Cymbalta with the aforementioned lot number and expiration date, discontinue use immediately and contact your healthcare provider. They can discuss alternative treatment options and determine if any additional monitoring is necessary.
FDA and Manufacturer Statements
The FDA is advising healthcare professionals to review their patients' medications and discontinue use of affected Cymbalta batches. Additionally, they emphasize the importance of reporting any adverse reactions to the FDA.
Eli Lilly and Company, the manufacturer of Cymbalta, has issued a statement assuring patients of their commitment to patient safety. They are working with healthcare providers and distributors to ensure the prompt removal of affected batches from circulation.
Protecting Yourself
While the immediate risk associated with the Cymbalta recall is considered low, long-term exposure to excessive N-nitroso-duloxetine is a concern.
By following the FDA and manufacturer recommendations, patients can take steps to ensure their safety and continue receiving appropriate treatment for their condition.