FDA recalls thousands of bottles of antidepressants over toxic chemical

Abstract

In late October, the Food and Drug Administration (FDA) recalled more than 7,000 bottles of the popular antidepressant duloxetine, sold under the brand name Cymbalta, Consumer Affairs reported on Oct. 24. The agency found that the affected bottles of the drug, which is used to treat depression, anxiety and mood disorders, contained toxic levels of the chemical nitrosamine. While the FDA says that the chemical isn't likely to cause harm in low levels and that consumers can handle low levels of the chemical for 70 years without health risks, it can increase the risk of cancer and become toxic to humans when ingested at higher-than-acceptable levels over an extended period of time. “FDA, in collaboration with regulatory counterparts around the world, has set internationally recognized acceptable daily intake limits for nitrosamines,” the agency said. “If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.” Currently, this recall is classified as a Class II recall, which the FDA defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Towa Pharmaceutical Europe manufactured the contaminated pills, which were distributed across the United States. In total, there are 7,107 bottles of duloxetine that have higher-than-normal levels of nitrosamines. The affected medications are 20 mg pills that come in bottles of 500 pills and have an expiration date of December 2024 with a lot number of 220128.