Thousands of bottles of the antidepressant duloxetine have been recalled over elevated levels of an impurity suspected of causing cancer.
Thousands of bottles of the antidepressant duloxetine have been recalled over elevated levels of an impurity suspected of causing cancer. The recall concerns the presence of N-nitroso-duloxetine, a type of compounds called nitrosamines that are common in cured and grilled meats, dairy and vegetables and are found in some medications. According to the FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.” The affected antidepressant, called duloxetine, comes in delayed-release capsules at a dosage of 30 mg in 1000-capsule bottles. The drug was voluntarily recalled by manufacturer Towa Pharmaceutical, and it's distributed by Breckenridge Pharmaceutical Inc. According to the FDA, people who take drugs containing nitrosamines, even as often as daily for 70 years, are not expected to have an increased risk of cancer as long as the nitrosamine levels are at or below the recommended limit. The agency marked the recall as Class 2, where use of or exposure to the product may “cause temporary or medically reversible adverse health consequences.” The recalled bottles have the lot number 241180C and an expiration date of April 2027.
