Topical ophthalmic drugs and the pediatric patient

More than 80% of the drugs on the market labeled for adult use contain no information on pediatric use-even for drugs commonly prescribed for pediatric patients. Without adequate pediatric labeling information, practitioners may be prescribing medications and placing their pediatric patients at risk for adverse reactions.

This article reviews the 98 most commonly used or prescribed topical ophthalmic drugs (TODs) and provides a summary of their safety for use in children. Additionally, the article includes the best sources of information the practitioner can use to find information on the pediatric safety of TODs.

There is pediatric use labeling for 51% of the TODs included in this article (specifically, by drug category, pediatric use safety profiles are present for 100% of anti-virals, 88% of antibiotics, 67% of anti-allergy drugs, 67% of diagnostic agents, 55% of steroid-antibiotic combinations, 54% of lubricants, 50% of nonsteroidal anti-inflammatory drugs (NSAIDs), 31% of steroids, and 11% of glaucoma medications).

Sufficient pediatric safety labeling information is available to the practitioner for topical antibiotics, anti-allergy medications, antivirals, lubricants, and diagnostic pharmaceutical agents. Little or no information is available on the pediatric safety of topical steroids and glaucoma medications. For the majority of the steroid and glaucoma drugs, pediatric use is labeled "not recommended" (NR).