The EMA and the European Commission have just updated the safety warnings for excipients in package leaflets.
Excipients are the inactive ingredients in a medicine–diluents, binders, disintegrants, colouring agents–that give the medicine its final dosage form. In practice, however, some excipients are not completely inactive and cause reactions in certain patients or under certain circumstances.
Excipients with a known action or effect must have safety information statements in package leaflets. These warnings are listed in an annex that was updated this week, following a public consultation. The result is five new excipients and updated safety information for ten excipients from the legacy 2003 annex.
The revised English annex has already been translated into all EU and EEA languages. All versions are published in the Human Regulatory section of the EMA website.
Changes in content
The five new excipients are boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate, and …