U.S. Food and Drug Administration (FDA) has declared more than 580,000 bottles of a common blood pressure medication have been pulled 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, which 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, FDA classified it as a Class II recall.
As mentioned in the enforcement report of FDA, the testing of the medication 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 nitroso group (NO+) that are “probable human carcinogens,” bonded to a deprotonated amine. Most nitrosamines are carcinogenic in animals.
Their possibility of formation can be during the manufacturing process or during storage.
FDA explained that exposure to this chemical “may cause temporary or medically reversible adverse health consequences or where the probability of serious health consequences is remote.”
The recall spans three different dosage strengths of Prazosin Hydrochloride capsules that were distributed nationwide. The affected products are:
Patients should not abruptly stop their medication as it can pose serious health threats. FDA recommends patients to take following steps:
Other common medications like Zantac have also been recalled due to nitrosamine impurities in the past.