Over 580,000 bottles of blood pressure medications containing valsartan, losartan, and irbesartan have been recalled due to the presence of a cancer-causing chemical impurity, the U.S. Food and Drug Administration (FDA) announced.
New Jersey-based Teva Pharmaceuticals USA and drug distributor AmerisourceBergen voluntarily issued nationwide recalls earlier this month for more than 580,000 bottles of various strengths of prazosin capsules, the FDA reported. The recall followed testing that identified a probable cancer-causing chemical impurity, prompting concerns about patient safety.
Doctors prescribe prazosin to relax blood vessels, thereby lowering blood pressure by reducing peripheral resistance. It works as an alpha-1 adrenergic receptor antagonist, blocking these receptors on vascular smooth muscle. This blockage prevents catecholamines like norepinephrine from causing blood vessel constriction, leading to vasodilation and a subsequent drop in blood pressure.
FDA officials made it clear that the impurity found, classified as a probable human carcinogen, is linked to nitrosamine compounds that formed during manufacturing. FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, M.D., said, “We act quickly to remove medicines containing unacceptable levels of these impurities from the market to protect patients.” She emphasized that the agency works closely with manufacturers to identify and remove contaminated batches and to ensure safer production processes going forward.
FDA Commissioner Scott Gottlieb, M.D., added, “Patients should not stop taking their medication without talking to their healthcare provider, as untreated high blood pressure poses its own serious health risks.” The FDA advises patients to check with their pharmacists or doctors if their medication is part of the recall and to obtain safe replacements.
The recalled medications were traced to specific lots produced overseas where certain chemical reactions likely caused the contamination. The FDA stated that it continues ongoing testing of angiotensin II receptor blockers (ARBs) to monitor nitrosamine impurities and safeguard the drug supply.
The FDA defines N-nitrosamine impurities as a class of chemicals that contain a nitroso group bonded to an amine structure. These impurities can form during drug manufacturing or storage, often arising from chemical reactions involving secondary or tertiary amines in the presence of nitrosating agents under acidic conditions. Nitrosamines are known to be probable human carcinogens, meaning long-term exposure at unacceptable levels could increase cancer risk.
Patients are urged to consult the FDA’s website or healthcare providers for detailed recall information and next steps. The FDA stressed its commitment to patient safety while working to prevent future occurrences of impurity contamination in vital medications.
Two weeks ago, the FDA recalled a popular statin medication.
