TOPLINE:

Over the past 26 years, drug labels were updated to include pediatric information, but more than half of the medicines studied still came only as adult pills. Labels often lacked guidance on how to modify use for children when only adult forms of the medicines were available, and alternatives were often missing after child‑friendly versions were discontinued.

METHODOLOGY:

• Children often need pediatric-friendly forms of medicines such as liquids, dissolvable tablets, or sprinkles. Although laws boost studies on pediatric drugs, they do not require companies to market child-friendly formulations.
• In this retrospective analysis, researchers reviewed 611 FDA changes in pediatric labeling for oral drugs between February 1998 and January 2025.
• Adult forms of drugs included tablets and capsules. Pediatric-friendly forms included liquids, orally dispersible tablets, powders, sprinkles, pellets, granules, sublingual or lozenges forms, and oral concentrates.
• Researchers assessed whether child-friendly formulations existed at the time of labeling, whether they stayed on the market, if same‑dose same‑form alternatives were available, and whether labels gave instructions for pediatric use when no child‑friendly form was sold.

TAKEAWAY:

• For 53.8% of labeling changes, the only marketed option was a solid oral form, even for many drugs used in children aged 12 years or younger.
• Standalone pediatric-friendly formulations were discontinued at rates similar to adult formulations but were about two and three times more likely to lack a generic or over-the-counter alternative, respectively.
• When both adult and pediatric-friendly formulations were initially marketed, pediatric formulations were discontinued about four times more often than adult formulations, whereas the adult form stayed on the market. Alternatives were also more often unavailable for pediatric-friendly formulations.
• When pediatric-friendly formulations were not marketed, only 56% of labels provided guidance on whether adult forms of medicines could be altered for children who could not swallow them, and if so, then how (such as instructions allow chewing or crushing).

IN PRACTICE:

“These observations beg the question of whether manufacturers leveraging federal incentives to bring pediatric drugs to market should be held to a reasonable expectation of accessibility irrespective of the effective patent life remaining at the time of pediatric approval,” the authors of this study wrote. “Manufacturers, clinicians, and regulators should collaborate to explore solutions that may lead to improved medication options for pediatric patients.”

SOURCE:

This study was led by Susan M. Abdel-Rahman, PharmD, of the Center for Drug Evaluation and Research in Silver Spring, Maryland. It was published online on December 8, 2025, in Pediatrics.

LIMITATIONS:

Multiple changes in laws and markets may have occurred over 26 years. Public data limited insight into why child‑friendly forms were not available or how fast products were discontinued after labeling. The findings may not apply to drugs for rare diseases.

DISCLOSURES:

This study did not receive any specific funding. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.