News from the PRAC – September 2013


PRAC recommends restriction to the use of short-acting beta-agonists in obstetric indications

The PRAC recommended that oral and suppository forms of short-acting beta agonists should no longer be used in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions. However, injectable forms of these medicines should remain available for short-term obstetric use under specific conditions.

PRAC recommends temporary suspension and reformulation for Numeta G13%E and risk minimisation measures for Numeta G16%E

The PRAC recommended temporary suspending the marketing authorisation of Numeta G13%E, until the a reformulation has been authorised. The medicinal product is intended for intravenous nutrition of premature babies, as a nutritional support. For Numeta G16%E ,used as intravenous nutrition for full-term newborns and children up to two years of age, the PRAC considered the benefit-risk balance to be positive, provided that risk minimisation measures are implemented.

New safety assessment for bromocriptine

The PRAC started a new assessment procedure for bromocriptine -containing medicines when used orally for suppressing lactation (milk production) in women following childbirth. The PRAC will assess whether the benefits of these medicines outweigh the risk of potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects.

Here you may find more information about the PRAC recommendations from September 2013.