EMA Tells Firms To Evaluate OTCs For Carcinogenic Nitrosamines

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.

The agency says the evaluation – which also applies to branded and generic prescription drugs – is necessary in light of the detection of nitrosamines, probable human carcinogens, in some sartan medicines last year. It comes less than two weeks after the EMA launched a review of all ranitidine drugs in response to the detection of nitrosamine impurities in certain products, including OTCs