Since the European Medicines Agency (EMA) last revised excipient labelling rules in 2003 evidence of differing effects of inactive ingredients on children, unborn babies, and adults has grown. In response the EMA plans to update its excipient labelling guidelines to better protect these patient populations.
“Several safety concerns regarding excipients have been identified which are not currently addressed in the guideline. Proper labelling is needed to ensure the safe use of medicinal products containing certain excipients of concern”, the EMA wrote in a concept paper.
Perceived shortcomings in the current guidelines centre on protection of children and unborn babies. “It is important to note that the safety of excipients can affect children differently than adults due to the ongoing organ development and incomplete maturation depending on the age”, the EMA wrote.
In 2009 UK-based researchers noted these safety fears in a specific paediatric population – preterm babies. The report found preterm babies were exposed to more than 20 excipients, some of which were administered in concentrations in excess of maximum exposure limits for adults.
Some of the excipients are toxic and to better protect these vulnerable patients the researchers asked the EMA to make industry provide detailed labelling of the excipient content of their products.
The concept paper looks like a step in this direction. Release of a draft revised guideline document is planned for late 2013, early 2014, after which a six month external consultation period will begin.
The EMA is also concerned about the effect of excipients on unborn children. “Pregnant women are another sensitive population currently not covered in the guideline. Safety labelling is needed for products intended for use in this population”, the EMA wrote.
Other problems the EMA plans to fix include: a lack of information about alternative routes of administration for certain inactive ingredients; oversights in the excipients included in the guideline; and a lack of information about warnings in the summary of product characteristics.