EMA has considered the relevant toxicology data and written statements proposing changes to the package leaflets of medicinal products containing three groups of excipients. For aspartame, used to make pharmaceuticals more palatable, its metabolism to phenylalanine is critical; high levels of phenylalanine are neurotoxic, so aspartame may be harmful for patients with phenylketonuria, who cannot convert phenylalanine into tyrosine. There are also no data available to conclude on the safety of aspartame in children younger than 12 years. Fructose and sorbitol (which is rapidly converted to fructose in vivo) are used as excipients in a variety of oral and topical pharmaceuticals. EMA raised concerns for individuals with intolerance to some sugars (particularly those with hereditary fructose intolerance, HFI). For the third group of excipients, fragrances containing allergens, EMA requested that the labelling of 26 fragrance allergens (already required for cosmetic and detergent products) should be extended to cover topically-applied medicines.

European Medicines Agency (2016). Information in the package leaflet for [aspartame, fragrances containing allergens, fructose and sorbitol] in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1). Draft reports dated 28 April 2016. Available via http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000387.jsp&mid=WC0b01ac05808c01f6


The above items were taken from the June 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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