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Prescribed in case of vomiting or nausea, Primperan, already contraindicated for infants, is recommended since 2011 to less than 18 years, according to an opinion issued by the marketing authorization commission of the French Agency for Health Safety of Health Products (AFSSAPS).
In which cases is Primpéran prescribed?
- This medicine, which exists in different forms (syrup, suppository and tablet) is prescribed in case of vomiting or nausea. Until now it was only contraindicated for newborns.
What are the side effects of the medication?
- The Primeran and its generics cause neurological side effects, such as abnormal movements of the head and neck, torticollis, facial spasms, jaw contractions, difficulty speaking and swallowing.
What does Afssaps recommend?
- Afssaps re-evaluated the risk benefit of metoclopramide-based drugs, including Primperan. According to the results, the risk that this drug represents for the child is greater than the benefit it could derive from it.Afssaps therefore recommends the outright withdrawal of all Primpéran specialties for pediatric use (Primperan Infants and Children). 2.6mg / ml oral solution and Primperan Children 2.6mg / ml oral solution).
- Health professionals will be kept informed of this restriction of use and the proposed re-evaluation of the benefit / risk ratio in adults.
(News of 19/10/11)