by Parsippany, NJ – The U.S. Food and Drug Administration has announced a significant recall of more than 580,000 bottles of the blood pressure medication prazosin hydrochloride due to the presence of a cancer-causing chemical impurity. This voluntary recall was initiated by Teva Pharmaceuticals USA on October 7 and classified as a Class II risk by the FDA on October 24, signaling potential temporary or medically reversible health effects.
Prazosin, FDA-approved for high blood pressure treatment, is also prescribed off-label to manage symptoms linked to post-traumatic stress disorder (PTSD), such as nightmares and sleep disruptions. The recall has raised concerns among patients relying on this medication.
The Cancer-Causing Chemical and Recall Details
The FDA’s Class II risk classification highlights that while serious adverse outcomes are unlikely, the medication may contain nitrosamine impurities, specifically “N-nitroso Prazosin impurity C,” a chemical connected to cancer risks. Exposure to this impurity can cause severe health issues, prompting prompt action.
The recall involves prazosin hydrochloride capsules in the following quantities:
- 1 mg capsules: 181,659 bottles
- 2 mg capsules: 291,512 bottles
- 5 mg capsules: 107,673 bottles
The bottles vary in size, containing anywhere from 100 to 1,000 capsules per bottle.
Advice for Patients with Recalled Medication
Neither Teva Pharmaceuticals nor the FDA has issued specific guidance on returning or disposing of the recalled capsules. However, medical experts and resources like GoodRx recommend patients:
- Check their medication lot number carefully.
- Contact their pharmacist to report and discuss the recall.
- Consult their healthcare provider for alternative treatments or prescriptions.
- Dispose of the recalled medication safely as recommended by pharmacists or local disposal guidelines.
“The presence of nitrosamine impurities in medications is a growing concern. Patients should not stop medications abruptly but seek advice from healthcare professionals promptly,” said a health expert cited in the FDA’s enforcement report.
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Background and Expert Commentary
Prazosin works by relaxing blood vessels to improve blood flow and reduce blood pressure. It also helps alleviate PTSD-related symptoms off-label. The recall reflects ongoing vigilance by the FDA to ensure drug safety standards are maintained.
For detailed information on the recall lot numbers and code information, individuals can visit the FDA’s Enforcement Report.
What Happens Next?
Patients currently using prazosin should follow up with their healthcare providers to evaluate their treatment plan and avoid potential health risks. Pharmacies are expected to update their stock in compliance with the recall.
Key takeaways:
- Over 580,000 bottles of prazosin hydrochloride capsules recalled.
- Recall due to a cancer-causing nitrosamine impurity.
- FDA has designated the recall as a Class II risk.
- Patients urged to verify medication and consult healthcare professionals.
What do you think about this recall and its impact on blood pressure management? Share your thoughts in the comments below!
