The U.S. Food and Drug Administration issued a recall this week affecting thousands of bottles of duloxetine, an antidepressant sold under the name Cymbalta, after discovering traces of a chemical that can cause cancer.
In the recall notice, the FDA said the agency found traces of a nitrosamine, or carcinogenic, substance in bottles of duloxetine above the legal limit.
“If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer,” the FDA said in its notice. “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
The recall is listed as a Class II recall by the FDA, meaning that exposure to the recalled drugs could cause temporary or reversible health consequences. The recall affects over 7,000 bottles of the medication.
The two most popular name-brand medications that use duloxetine are Cymbalta and Yentreve. The drugs are used to treat nerve pain, anxiety, depression and incontinence.
The FDA urged patients who think their medication could fall under the recall to contact their pharmacy for further information.
“The FDA encourages patients to talk to their health care professional if they have questions about their medicine, as the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines,” the FDA said in a statement.
• Vaughn Cockayne can be reached at vcockayne@washingtontimes.com.
Please read our comment policy before commenting.