ISLAMABAD: Teva Pharmaceuticals has announced a recall of more than half a million bottles of prazosin hydrochloride after detecting harmful impurities that may increase cancer risk. The medication, commonly prescribed for high blood pressure and other conditions, is widely used across the United States.
The US Food and Drug Administration (FDA) has classified the recall as Class 2, indicating that while the drug may cause temporary or reversible health effects, serious harm is unlikely. Patients are advised not to stop taking the medication without consulting their healthcare provider, as abrupt discontinuation may be more harmful.
The recall affects prazosin hydrochloride in 1 mg, 2 mg, and 5 mg dosages. In addition to treating high blood pressure, the drug is used off-label for benign prostate enlargement, PTSD-related nightmares, and temporary skin discoloration caused by cold exposure.
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The impurities in question, known as N-nitrosamines, can form during drug manufacturing or storage and are linked to an increased risk of cancer when present in high levels over long periods. While nitrosamines are naturally found in foods and the environment, the FDA has strict limits for their presence in medications.
Teva has not provided instructions on whether patients should discard affected bottles. Consumers are encouraged to check the lot number on their prescriptions and contact their doctor or pharmacist if they are unsure about the recall.
The FDA notes that exposure to nitrosamines at or below the acceptable limits is not expected to significantly increase cancer risk over a lifetime of use.
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