The American Food and Drug Administration is planning to tighten up drug labelling so that manufacturers have to give more information about their likely effects on children.
The move follows an informal study in 1990 which found that 80 per cent of products approved between 1984 and 1989 had no information on administering to children. Many drugs which are routinely prescribed for children have only ever been tested on adults.
Under the proposed change, manufacturers will have to state what evidence they have for believing a drug is appropriate for children and for their recommended dosages. They will also have to make it clear if it is not known what a drug’s effect is likely to be on babies and children.
The move is intended to encourage drug companies to conduct more studies specifically into the prescribing of drugs to children.