SAHPRA – review of certain products due to possible unacceptable carcinogen content.
If The International Regulatory Agencies have started investigating active ingredients that have common N-Nitrosamine impurities – which develop during the manufacturing process of these active ingredients (and which are above-authorized levels and are potential carcinogens). The active ingredients include azilsartan, candesartan, eprosartan, irbesartan, losartan, Olmesartan, telmisartan, valsartan, BUT also includes ranitidine.
Thus, SAHPRA – our local Regulatory Authority is reviewing all existing and all new applications that have been submitted to them to prevent products being registered with an active ingredient that does not conform to the required standard.
If vets are selling/ supplying compounded ranitidine products (as authorized to do as compounded products) they also need to recognise their responsibility in supplying a compounded product, and advising the client of any risks.
Whether this SAHPRA concern has the same implications for horses as for humans is currently unclear, but as professionals, we need to be aware of this. Please see the link relating to this notice below:
Glynn Catton – SAEVA Medicine commitee
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