Primperan, a medicine prescribed for vomiting or nausea, was not recommended for children since the end of 2011. After reassessing the benefit / risk ratio in children, Afssaps decided to contraindicate these specialties. under 18 years old. Pediatric lots will be withdrawn from the market.
- After reassessing the benefit / risk ratio metoclopramide (Primpéran® and generics) in children, Afssaps decided to contraindicate these specialties in children under 18 years.
- Consequently, the marketing authorizations have been revised in order to mention the contraindication in children under 18 and to specify that the use is reserved for adults. These changes have been effective since February 09, 2012, at which time a batch recall was implemented.
- Specialties for pediatric use only, discontinued since July 2011, will be withdrawn from the market.
Why such a measure?
- The Primeran and its generics are accused of causing neurological side effects, such as abnormal movements of the head and neck, torticollis, facial spasms, jaw contractions, difficulty speaking and swallowing.
- If your child takes Primpan currently, contact your doctor who will guide you.
The European Medicines Agency (EMA) is also expected to decide on the use of metoclopramide in the elderly, due in particular to the risk of neurological and cardiovascular adverse effects.