Major US Blood Pressure Medication Tainted with Cancer-Causing Chemical, FDA Announces Nationwide Recall
The Food and Drug Administration (FDA) has issued a nationwide recall of over 580,000 bottles of blood pressure medication prazosin hydrochloride due to concerns that it may contain nitrosamine impurities - substances considered potentially cancer-causing. The voluntary recalls were initiated by Teva Pharmaceuticals USA and Amerisource Health Services.
Prazosin is prescribed to relax blood vessels and help lower blood pressure, as well as treat nightmares and other sleep disturbances associated with post-traumatic stress disorder (PTSD). Doctors have been advised to check the affected lots of the medication for potential contamination.
The FDA has classified the recalled medication under a Class II risk classification, indicating that while there is some risk of harm, it can be managed with prompt action. The agency warns that the N-nitrosamine impurities, which are commonly found in food and tobacco products, can form during the manufacturing or storage process of certain drugs.
As part of its enforcement actions, the FDA has posted notices online advising affected pharmacies and healthcare providers to inspect their stock immediately. Patients who have purchased prazosin capsules from these affected lots are advised to return them to the pharmacy where they were purchased for a refund.
The recall is a significant health alert issued by the regulatory agency in recent times, underscoring its dedication to safeguarding public health and ensuring that medication safety standards are upheld across the country.
The Food and Drug Administration (FDA) has issued a nationwide recall of over 580,000 bottles of blood pressure medication prazosin hydrochloride due to concerns that it may contain nitrosamine impurities - substances considered potentially cancer-causing. The voluntary recalls were initiated by Teva Pharmaceuticals USA and Amerisource Health Services.
Prazosin is prescribed to relax blood vessels and help lower blood pressure, as well as treat nightmares and other sleep disturbances associated with post-traumatic stress disorder (PTSD). Doctors have been advised to check the affected lots of the medication for potential contamination.
The FDA has classified the recalled medication under a Class II risk classification, indicating that while there is some risk of harm, it can be managed with prompt action. The agency warns that the N-nitrosamine impurities, which are commonly found in food and tobacco products, can form during the manufacturing or storage process of certain drugs.
As part of its enforcement actions, the FDA has posted notices online advising affected pharmacies and healthcare providers to inspect their stock immediately. Patients who have purchased prazosin capsules from these affected lots are advised to return them to the pharmacy where they were purchased for a refund.
The recall is a significant health alert issued by the regulatory agency in recent times, underscoring its dedication to safeguarding public health and ensuring that medication safety standards are upheld across the country.