OTC COLD REMEDIES TOO RISKY FOR YOUNG

Pharmacy Times, Volume 0, 0

The FDA recently made its first rulingon OTC cough and cold medicines forbabies and toddlers—avoid these drugsfor children under age 2 "because seriousand potentially life-threatening sideeffects can occur."

The issue surrounding cold remediesand young children heated up lastOctober when drug companies stoppedselling versions of medicines specificallytargeted to babies and toddlers. At thesame time, the FDA's own scientific advisersvoted that the medications are noteffective in small children and should notbe used in children under age 6. The publichealth advisory was issued becausethe agency is concerned that parentshave not gotten the message despite allthe media coverage.

Still on the table is whether the remediesare safe and effective for childrenunder age 12. Last fall, the agency's advisersdid not recommend that childrenaged 6 to 11 stop using the medications.The group did, however, call for additionalresearch to determine what effects theremedies have inyoungsters overall.Meanwhile, an internalFDA group has notreached a consensus regarding childrenaged 2 to 11 years.

This month is the deadline to send recommendationsto agency leaders,according to Charles Ganley, MD, director of the Office of NonprescriptionProducts at the FDA's Center for DrugEvaluation and Research. The FDA said toexpect a decision by spring.