The US Food and Drug Administration (FDA) says more than 580,000 vials of a common blood pressure medication have been removed from the market due to contamination with a potentially cancer-causing chemical.
The recall includes various strengths 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 PTSD-related nightmares.
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 prazosin hydrochloride was recalled
As mentioned in the FDA’s enforcement report, testing of the drug found that the capsules contained high 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 nitroso group (NO+) which are “probable human carcinogens”, linked to a deprotonated amine. Most nitrosamines are carcinogenic in animals.
Their training opportunity can be during the manufacturing process or during storage.
The FDA explained that exposure to this chemical “may cause adverse health consequences that are temporary or medically reversible, or where the likelihood of serious health consequences is low.”
Which medications are affected?
The recall covers three different strengths of prazosin hydrochloride capsules distributed nationwide. The products concerned are:
- 181,658 bottles of 1 mg capsules with lot numbers 3010544A and 3010545A, expiring October 2025.
- 291,512 bottles of 2 mg capsules spread across multiple lot numbers, with expiration dates ranging from October 2025 to July 2026.
- 107,673 bottles of 5 mg capsules with multiple expiration dates extending to 2026.
What patients should do
Patients should not stop treatment abruptly as this may pose serious health risks. The FDA recommends that patients take the following steps:
- Check with your doctor immediately to find out if your specified medicine is one of the recalled lots.
- Ask your doctor about a safer alternative option.
- Stop treatment under the direct supervision of a healthcare professional
Other common medications like Zantac have also been recalled in the past due to nitrosamine impurities.
