EMA Tells Firms To Evaluate OTCs For Carcinogenic Nitrosamines
Firms operating in the EU given six months to evaluate all OTC drugs containing chemically synthesized APIs for presence of nitrosamines, a probable human carcinogen. The order from EMA comes with a review of ranitidine underway after nitrosamine NDMA was detected in a number of OTC and Rx drugs.
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Guidance is FDA's latest action in response to findings that over time in storage, especially at higher temperatures, levels of the probable carcinogen NDMAincreases in some ingredients, including ranitidine available in OTC heartburn remedies.
Concerns over the presence of a probable human carcinogen will likely see marketing of all ranitidine-containing drugs suspended across the European Union.
A six-month suspension from sale has been handed to 23 ranitidine drugs sold in Australia. The country's regulator has suggested all 23 are facing a permanent ban over patient safety fears.