4. Reporting in Children

The MHRA ask that all suspected adverse reactions occurring in children under the age of 18, are reported regardless of whether the medicine is licensed for use in children.
It is particularly important to focus on the safety of medicines in children because:

  • very little is known about the safe use of medicines in this age group
  • generally children are not exposed to medicines in clinical trials
  • many drugs that are routinely used to treat children are not licensed in this age group
  • the action of the drug and pharmacokinetics in children (particularly the very young) may be different to adults
  • children may be more susceptible to developmental disorders or they may have delayed adverse reactions which do not occur in adults
  • the nature and course of illnesses and adverse reactions may differ between adults and children

Further guidance on the identification, prevention and reporting of adverse drug reactions can be found in the BNF for Children

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