PRAC recommends restrictions on the use of codeine for cough and cold in children
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.
The PRAC recommended specifically that:
- Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
- Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
- All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.
The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.
Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited
We would like to inform you that the “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” has been launched on the EMA website for public consultation. Please find the link below for your convenience:
Please submit your comments using the template form, which is available through a link in the cover page of this document.
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses, with new restrictions
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses,
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most EU countries. Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders.
More information on this, is included in the hyperlink below.
- PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
- PRAC recommends strengthening the restrictions on the use of valproate in women and girls Women to be better informed of the risks of valproate use during pregnancy
- PRAC review does not confirm increase in heart problems with testosterone medicines Committee recommends medicines can continue to be given for their authorised uses