Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 16 March 2015 | By Michael Mezher
A European committee is recommending a series of restrictions on the use of medicines containing codeine in children.
Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 and 18 with breathing problems should not take medicine containing codeine. The committee is also asking that liquid codeine-containing drugs come in child-proof packaging.
When codeine is ingested it is converted into morphine. This happens in both children and adults; however, the rate of conversion is more variable in children, which can make side effects less predictable.
Before a final guidance is adopted, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) will review PRAC’s recommendations on the issue. For the time being, EMA is recommending that patients consult their healthcare providers if they have any concerns regarding pediatric codeine use.
These recommendations follow a 2012-2013 review, which recommended codeine only be given to children under 12 as a last resort after less dangerous painkillers such as paracetamol or ibuprofen. PRAC’s new recommendations are more restrictive than before, and if adopted, would completely restrict codeine use in children under 12.
The recommendations also go a step further than recent requirements by the US Food and Drug Administration (FDA). In 2013, FDA issued a requirement for prescription codeine products to be labelled with a black box warning to inform consumers of the risk of fatal complications in children taking codeine after certain surgeries.
Tags: Codeine, Pediatric use, CMDh, PRAC
Regulatory Focus newsletters
All the biggest regulatory news and happenings.