Child cough medicines moved to S4

The NDPSC said non-phenothiazine sedating antihistamines (brompheniramine, chlorpheniramine, dexchlorpheniramine, diphenhydramine, doxylamine, pheniramine and triprolidine) would be rescheduled from Schedule 3 to Schedule 4, when in oral preparations for the treatment of children under two years of age. The committee reached its decision at its February meeting, it was revealed today.

In its record of reasons the committee said that while there was little evidence of increased morbidity and mortality among infants taking the medications it was persuaded to make the change due to the lack of evidence of the products' efficacy.

"Members felt that this apparent lack of efficacy and side effect profile may warrant further evaluation before these products may be safely used in children under two years of age. Members agreed that the risks associated with the use of these products in children under two years of age might outweigh any potential benefit from their use," the record said.

The committee was also concerned that parents may be using the drugs inappropriately.

"It might be for some parents that sedation per se was the reason they sought to use these drugs, rather than the conditions which the products are actually indicated for," it said.

Some products that will be affected by the changes include Dimetapp, Demazin, Paedamin and Polaramine.