Following a review into the risk of cardiovascular side effects with high doses of short-acting beta-agonists when used as tocolytics, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) made the following recommendations:
• The benefit-risk balance of the oral and suppository forms of these medicines is not favourable and they should no longer be used in obstetric indications.
• The benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all EU Member States, and healthcare professionals will be informed in writing of the updated recommendations. Oral and suppository formulations of short-acting beta-agonists which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.