The European Medicines Agency (EMA) has asked the
human medicines committee (CHMP) to provide guidance on avoiding the presence
of certain carcinogenic ingredients in drugs, after nitrosamines were found to
be present in a prevalent form of blood pressure medication.
The regulatory body is drafting directions on
nitrosamine impurities in medications containing chemically synthesised active
substances.
The CHMP will produce guidance on reducing nitrosamine
impurities to marketing authorisation holders.
“We will continue to work with our partners to address
the presence of nitrosamines and reassure patients about the quality of their
medicines,” says the Executive Director Professor Guido Rasi.
Nitrosamines are classified as probable human
carcinogens, following animal studies.
Following the identification of the carcinogenic
ingredient in sartans, the EMA is seeking a “proactive approach” for other
classes of medicines. The ingredient has been detected in batches of
pioglitazone and in batches of ranitidine.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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