FDA Recalls Blood Pressure Drug Due to Cancer-Causing Chemical
Teva Pharmaceuticals has issued a significant recall affecting over 580,000 prazosin hydrochloride capsules due to concerns over a potential cancer-causing chemical. The U.S. Food and Drug Administration (FDA) announced this voluntary recall on October 7, with a classification of Class II risk assigned on October 24.
Details of the Recall
The recall specifically targets prazosin hydrochloride capsules that have been linked to nitrosamine impurities, known as “N-nitroso Prazosin impurity C.” These impurities may pose serious health risks to users. This medication is primarily prescribed for managing high blood pressure, but it is also sometimes used off-label for treating post-traumatic stress disorder (PTSD) symptoms, such as nightmares and sleep disturbances.
Statistics of the Recalled Products
- 1 mg capsules: 181,659 bottles
- 2 mg capsules: 291,512 bottles
- 5 mg capsules: 107,673 bottles
The total number of recalled bottles may vary, containing anywhere from 100 to 1,000 capsules each.
FDA’s Risk Classification
The FDA has classified this recall as a Class II risk, indicating that the use of the affected product may lead to temporary or medically reversible health issues, while the likelihood of serious adverse effects remains low.
Recommendations for Consumers
Currently, Teva Pharmaceuticals has not provided specific guidance regarding the recalled capsules. However, according to GoodRx, individuals who possess these medications should:
- Check the lot number on their medication.
- Contact their pharmacist or prescriber for further advice.
- Dispose of the recalled medication safely.
Consumers are advised to stay informed about this and other recalls, including those pertaining to food products and medications, to ensure their safety. For more details about the recall and specific lot numbers, consult the FDA’s Enforcement Report.
