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EMA Tells Firms To Evaluate OTCs For Carcinogenic Nitrosamines

 
• By Tom Gallen

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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Marketing authorization holders in the EU should review all their OTC drugs containing chemically synthesized active pharmaceutical ingredients for the possible presence of nitrosamines and test all products at risk, the European Medicines Agency has requested.

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