This white paper describes the current status and causes of contamination of pharmaceutical products by the genotoxic impurities known as nitrosamines. Both commonly prescribed heart protection drugs (known as angiotensin II receptor blockers – ARBs – or ‘sartans) and the widely used H2 (histamine-2) blocker drugs, ranitidine (Zantac) and nizatidine (Axid), both used for prevention of acid in the stomach, have been found to contain nitrosamine compounds.
Health authorities worldwide have rescinded GMP certification, sent Warning Letters, and imposed import alerts or recalls on manufacturers of both the active pharmaceutical ingredients (API), the packaged drug products, and even manufacturing intermediates like solvents. Dozens of drug manufacturers and pharmacies have voluntarily recalled and removed product from shelves, leaving many consumers unsure whether to continue taking their medicine.
In both cases, the culprit is the same potentially mutagenic compound, NDMA (N Nitrosodimethylamine). While the root cause in the original ‘sartans contamination is believed to have been identified, in the case of ranitidine and nizatidine, the source appears much more difficult to track down and characterize, meaning that it might not be easily solvable.