The US Food and Drug Administration (FDA) has stated that more than 580,000 bottles of a common blood pressure medication have been recalled due to contamination with a potentially carcinogenic chemical.
The recall includes various concentrations of “prazosin hydrochloride” capsules. The drug is commonly used to treat high blood pressure and prostate conditions, and is also sometimes prescribed off-label for nightmares related to post-traumatic stress disorder.
New Jersey-based Teva Pharmaceuticals USA initiated the recall earlier this month. On October 24, the FDA classified it as a Class II recall.
Why was prazosin hydrochloride taken off the market?
As mentioned in the FDA compliance report, testing of the drug revealed that the capsules contained elevated levels of an impurity known as “N-nitroso prazosin.”
The chemical structure is R2N−N=O, where R is usually an alkyl group. Nitrosamines have a nitrous group (NO+) that are “probable human carcinogens,” attached to a deprotonated amine. Most nitrosamines are carcinogenic in animals.
Its possibility of formation can be during the manufacturing process or during storage.
The FDA explained that exposure to this chemical “may cause temporary or medically reversible adverse health consequences or where the likelihood of serious health consequences is remote.”
What medications are affected?
The recall covers three different doses of prazosin hydrochloride capsules that were distributed nationwide. The affected products are:
- 181,658 bottles of 1 mg capsules with lot numbers 3010544A and 3010545A, expiring in October 2025.
- 291,512 bottles of 2 mg capsules in multiple lot numbers, with expiration dates from October 2025 to July 2026.
- 107,673 bottles of 5 mg capsules with multiple expiration dates extending to 2026.
What should patients do?
Patients should not abruptly stop their medication as it can pose serious health threats. The FDA recommends patients take the following steps:
- Consult your doctor immediately to find out if the medicine of your specification is part of recalled lots.
- Ask your doctor about any safer alternative options.
- Discontinue the medication under the direct supervision of a healthcare professional.
Other common medications like Zantac have also been recalled due to nitrosamine impurities in the past.
