FDA Announces Recall of Blood Pressure Drug Contaminated with Cancer-Causing Chemical
The U.S. Food and Drug Administration (FDA) has announced a significant recall involving blood pressure medication, specifically prazosin hydrochloride. This recall affects over 580,000 bottles due to concerns regarding contamination with a cancer-causing chemical.
Details of the Recall
Teva Pharmaceuticals USA, based in New Jersey, along with distributor Amerisource Health Services, initiated the voluntary recall earlier this month. The FDA classified the affected lots as Class II risk due to the potential presence of nitrosamine impurities.
- Total Bottles Recalled: Over 580,000
- Medication Name: Prazosin Hydrochloride
- Manufacturers: Teva Pharmaceuticals USA and Amerisource Health Services
- FDA Risk Classification: Class II
Health Implications
Prazosin is primarily prescribed to relax blood vessels and lower blood pressure. Additionally, it is often used to address nightmares and sleep disturbances associated with post-traumatic stress disorder (PTSD). However, the FDA has raised alarms about the potential health risks linked to the recalled batches.
- Concern: Presence of N-nitrosamine impurities
- Health Risk: Considered potentially cancer-causing
Understanding Nitrosamine Impurities
N-nitrosamine impurities can form during the manufacturing or storage processes of pharmaceuticals. These chemicals have drawn attention due to their association with various types of cancer.
Consumers and healthcare providers are urged to check any prazosin bottles in their possession and report any adverse effects to the FDA. As always, professionals are advised to consult patients on alternative therapies and potential risks linked to the contaminated medication.
