The U.S. Food and Drug Administration (FDA) has announced the recall of more than half a million bottles of the blood pressure medication prazosin hydrochloride due to possible contamination with a potentially cancer-causing chemical.
According to the FDA, Teva Pharmaceuticals USA, based in New Jersey, and Amerisource Health Services voluntarily recalled over 580,000 bottles of prazosin capsules in various strengths earlier this month.
Prazosin is widely prescribed to lower blood pressure by relaxing blood vessels and is also used to treat nightmares and sleep disturbances associated with post-traumatic stress disorder (PTSD).
The FDA classified the affected lots as a Class II recall, meaning that exposure to the product may cause temporary or medically reversible health effects, or that serious health risks are possible but less likely.
The agency said the recall was initiated due to possible contamination with nitrosamine impurities—a group of chemicals that can form during drug manufacturing or storage and have been linked to cancer risks in long-term exposure.
Nitrosamines have been detected in several medications in recent years, prompting global recalls of certain blood pressure drugs, diabetes treatments, and heartburn medications.
The FDA said patients currently taking prazosin should not stop the medication abruptly and should consult their healthcare provider for guidance.
Teva and Amerisource have not reported any adverse events related to the affected lots, the FDA said.
Source: UNB
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