Breckenridge Pharmaceuticals is recalling nearly 370,000 bottles of prescription Duloxetine nationwide, a medication used to treat depression, anxiety, and nerve damage, Fox 8 reported on 15/6. This decision follows a warning from the U.S. Food and Drug Administration (FDA) that the pills may contain toxic N-nitroso-duloxetine impurity above safe levels.
Duloxetine works by increasing two neurotransmitters, serotonin and norepinephrine, in the brain, according to Mayo Clinic. Beyond treating depression and anxiety, this medication is commonly prescribed for fibromyalgia and diabetic neuropathic pain.
The U.S. National Library of Medicine states that N-nitroso-duloxetine, the impurity found in the medication, is a "suspected carcinogen" and notes it is "toxic if swallowed." However, the California State Board of Pharmacy clarified that exposure to this substance does not immediately cause cancer. Nitrosamines are common in daily water and foods, including cured meats, grilled meats, dairy products, and vegetables. Everyone encounters nitrosamines to some extent.
These impurities can only increase cancer risk if human exposure exceeds permissible levels over an extended period. The agency also noted that the distributor has not received any reports of adverse reactions related to this recall.
Illustration: Mayo Clinic Health System
The FDA classified this recall as Class II, indicating that the product may cause temporary or medically reversible adverse health consequences.
Binh Minh (According to Fox8, FDA, ABC News)
