FDA Recalls Half a Million Bottles of Blood Pressure Drug Due to High Levels of Cancer-Causing Chemical
On the smooth surface lining of the muscles in our blood vessels and some organs, are tiny switch-like protein cells called “alpha-1 adrenergic receptors.” When a person’s bloodstream gets flooded by stress hormones, such as during nightmares or post-traumatic stress disorders, doctors advise them to take capsules of “Prazosin,” a pacifying chemical that helps the person’s brain and body calm down. When the molecules of this chemical come in contact with these proteins, they relax the blood vessels, helping balance the patient’s blood pressure. In a recent case, however, the concentration of this chemical is so high in a medicine that it carries the potential of causing cancer. The FDA initiated a voluntary product recall on October 7, instructing chemists to pull this item from their shelves.
More than half a million, 580,844 bottles precisely, of this blood pressure medication have been recalled due to the potential contamination with Prazosin Hydrochloride. The recall was initiated in the " drugs " product category by Teva Pharmaceuticals, a company based in Parsippany, New Jersey, USA. A constellation of 1-milligram, 2-milligram, and 5-milligram capsules of the recalled medication were distributed in 100-capsule, 350-capsule, 500-capsule, and 1000-capsule bottles with expiration dates ranging from October 2025 through February 2027.
Prazosin, according to the Cleveland Clinic, can induce side effects like allergic reactions, skin rashes, itching, hives, swelling of the face, lips, tongue, or throat when consumed in overdose. The patient can also experience low blood pressure, dizziness, lightheadedness, blurry vision, drowsiness, fatigue, headache, rapid pounding of the heart, nausea, swelling in the ankles, hands, and feet. In extreme cases, like this one, the chemical can even trigger conditions in the body that might carry the potential of turning into a deadly cancer. The clinic suggests that patients with these symptoms report the side effects to the FDA at 1-800-FDA-1088.
Meanwhile, the FDA revealed that the recall was initiated after testers found extreme levels of the impurity “N-nitroso Prazosin impurity C” that were higher than the safety limit established by the Carcinogenic Potency Categorization Approach (CPCA). “This recall has been initiated in coordination with the FDA, and to date, Teva has not received any relevant complaints related to this product,” Teva Pharmaceuticals USA told The New York Post.
FDA has classified this recall as a “Class II” recall, which implies "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." The current status of the recall is “ongoing.”
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