The Taiwan Food and Drug Administration (TFDA) revealed on Monday that a medication primarily used for treating depression has been recalled due to the detection of nitrosamine impurities surpassing safe levels. This announcement follows Canada’s declaration on April 17 regarding elevated nitrosamine levels found in a batch of “pms-Duloxetine Capsules 30mg” during stability tests conducted by local manufacturers. Nitrosamines, when present above the daily acceptable intake limit, pose potential cancer risks, explained TFDA Deputy Director-General Wang Te-yuan.
The drug in question is utilized for managing major depressive disorder, generalized anxiety disorder, diabetic neuropathy, and fibromyalgia, as outlined by the TFDA. Wang emphasized in an interview that approximately 60,000 capsules from the problematic batch have been imported into Taiwan.
Upon receiving notification, the TFDA promptly instructed the Taiwanese distributor to withdraw the affected batch by May 17 and to furnish a report detailing the withdrawal outcomes and preventive measures for future occurrences.
Furthermore, hospitals, clinics, and pharmacies have been directed to collaborate on the withdrawal process and to halt the prescription or provision of the drug.
According to data from the National Health Insurance Administration, about 100,000 capsules of this medication are consumed domestically each year, constituting a mere 0.3 percent of the market due to the availability of numerous alternatives. Consequently, the withdrawal is not anticipated to result in a shortage of the drug.
As per the U.S. Food and Drug Administration, the consumption of a nitrosamine-containing drug on a daily basis for more than 70 years is not expected to elevate the risk of cancer, provided that the level remains at or below the acceptable limit.
