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Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety Advisory Committee

On Thursday, December 10, 2015, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee supported new restrictions on the pediatric use of codeine.

A majority of the Committee members, 21 of 29 members, voted to recommend a contraindication against the use of codeine, both for the treatment of pain and the treatment of cough in children under 18 years of age.

A majority of the Committee members, 27 of 29 members, also voted to remove the Over-the-Counter (OTC) monograph for codeine for the treatment of cough in children under 18 years of age.

Most of the Committee members also made a point to express support for the removal of the OTC monograph for all ages.