US Voluntary Labeling System "Inadequate"

17 February 1997

Drug labels are not specific enough, according to the American Academyof Pediatrics, which has now recommended mandatory labeling of inactive ingredients on prescription and over-the-counter products.

"The voluntary system is clearly inadequate," said the Academy in a report in the journal Pediatrics. Companies are not now required to disclose inactive ingredients on the labels of drugs taken orally; the AAP notes that these substances are rarely named because manufacturers want to preserve trade secrets.

However, inactive ingredients such as sweeteners and dyes can trigger breathing problems, seizures and diarrhea, the report said; the last two plus bronchospasms are the most common adverse reactions in children. A recent survey of 102 chewable and liquid pediatric drugs found that 90% reported on the label that a sweetener was included, but few provided the specific sweetener ingredients, said the report.

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