Copyright Newsweek
New Jersey-based drug manufacturer Teva Pharmaceuticals USA has issued a voluntary recall for some of its blood pressure medications after a deviation test for certain carcinogens came in “above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit.” Why It Matters Prazosin hydrochloride capsules are a type of prescription medication used to treat high blood pressure by relaxing the blood vessels, allowing blood to flow more easily through the body. The drug was approved by the FDA to treat high blood pressure, but it can sometimes be prescribed off-label to treat symptoms of post-traumatic stress disorder (PTSD), according to USA Today. High blood pressure affects nearly half of all adults in the United States, approximately 119.9 million people. N-Nitroso Prazosin impurity C is a nitrosamine, a class of chemicals that can form during the manufacturing process or during storage of some drugs, and is carcinogenic, according to Health.com. What To Know The recall was initiated earlier this month but only received classification last week from the Food and Drug Administration (FDA), which classed it as Class II, which means “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.” In this case, concerns arose around an unusually high level of N-nitroso Prazosin impurity C above CPCA acceptable limits for certain products, including: Prazosin Hydrochloride, Capsules, USP, 1 mg, which impacts 181,659 bottles sold Prazosin Hydrochloride, Capsules, USP, 2 mg, which impacts 291,512 bottles sold Prazosin Hydrochloride, Capsules, USP, 5 mg, which impacts 107,673 bottles sold All three variants are sold in 100, 500, and 1000 capsule bottles. These medications are alpha blockers taken to help lower blood pressure, and the concentration of N-nitroso Prazosin impurity C exceeded FDA acceptable levels. To date, Teva has not received any complaints related to the product, and the drugmaker has asked any patient who purchased the impacted medicines should contact the pharmacy that fulfilled the prescription and the health care provider who issued the prescription, as any interruption in a medication regimen can prove dangerous to a patient's health and therefore any change or transition to new medication requires careful consultation and planning. Other drug makers who have previously detected higher-than-acceptable levels of nitrosamines include Pfizer, Merck, Sandoz, and Rising Pharmaceuticals, according to Becker's Hospital Review.
