Counter-indicate in children under 2 years of #trimebutine (Débridat and generic).
the national agency for the safety of medicine and health products (#Msna) has carried out a re-evaluation of the benefit / risk ratio of specialties based on trimebutine alone (Débridat and generic). At the end of this re-Evaluation, the, débricalm and other reassessments are now counter-indicated in children under 2 years old.
the pharmacovigilance data evaluation of the shows a profile of side effects dominated by #skin and #immune _ allergic effects. #Neurological effects (Thrombocytopenia, seizures) and #heart (bradycardia) have also been reported in case of overdose and related to drug errors, especially in the baby.
this is why, due to the low level of proof of effectiveness and the risk of serious side effects in this age group, Specialties Based on trimebutine are now counter-indicated in children under 2 years old . The update of all amm is in progress to include this new information.
the reminds us that health professionals must immediately report any side effects that they are known to be due to a drug they know at the regional pharmacovigilance centre. Patients and approved patient associations can also report any side effects to their regional pharmacovigilance centre.
© Facebook page: Medicine Science
Section: #Pharmaco _ vigilance
Signed Doctor Lahbib, pharmacist
More info on the subject 
https://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Contre-indication-chez-l-enfant-de-moins-de-2-ans-des-specialites-a-base-de-trimebutine-Debridat-et-generiques-Point-d-Information