§ Mr. Ashleyasked the Secretary of State for Social Services what evidence has persuaded the Committee on Safety of Medicines that the drug Lomotil may be safely prescribed to infants aged one year, in view of the fact that this drug is contra-indicated for use in the age group in both Australia and the United States of America due to the decreased margin of safety.
§ Dr. Vaughan[pursuant to the reply, 13 November 1980, c. 431]: Lomotil was marketed in the United Kingdom before the implementation of the Medicines Act 1968 in 1971; consequently, it has not been the subject of scrutiny by the Committee on Safety of Medicines, though the adverse reactions reports are regularly monitored by the professional secretariat. Lomotil is available only on prescription and is contra-indicated for children under 1 year old; the manufacturer's data sheet includes the express warning that the drug should be used with caution in children over the age of one year
because of the variability of response in this age group".I am advised that the adverse reactions reports do not indicate any significant hazard to young children treated with Lomotil, provided that it is used in accordance with the indications, dosage and precautions currently recommended.