The U.S. Food and Drug Administration (FDA) has announced a significant recall of the antidepressant duloxetine, citing the presence of potentially harmful carcinogenic impurities. This recall comes after a routine quality check revealed that certain batches of the medication contained unacceptable levels of N-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen by the World Health Organization (WHO). The FDA stated that patients who are currently using duloxetine should consult their healthcare providers to discuss alternative treatment options. The recalled products include various dosages of duloxetine solid dosage forms, which were distributed by different manufacturers including Dr. Reddy’s Laboratories and Teva Pharmaceuticals. In a public statement, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, emphasized that “the safety of patients is our top priority” and confirmed that the agency is actively working with manufacturers to ensure the safety and efficacy of medications available in the market. The FDA has advised consumers to check their prescriptions and to return any affected products to the pharmacy for safe disposal. As part of the recall notice, healthcare providers are reminded to report any adverse events related to duloxetine to the FDA’s MedWatch Adverse Event Reporting program. Patients are encouraged to remain vigilant during this period to mitigate any health risks associated with the contaminated medications.
FDA Issues Urgent Recall of Antidepressant Duloxetine Due to Carcinogen Contamination
