Ophthalmic Medications in Pediatric Patients

Teresa M. Myers, MD; David K. Wallace, MD; Sandra M. Johnson, MD


Compr Ophthalmol Update. 2005;6(2):85-101. 

In This Article

Abstract and Introduction

Many ocular medications are prescribed and used for pediatric patients but data regarding their safety in this population are sparse. Systemic absorption carries a much greater risk in infants, where higher serum drug concentrations are achieved due to their smaller average blood volume. Indications and dosages, as well as the data regarding efficacy and side effects in children of commonly used ophthalmic medications are reviewed here.

Many ocular medications are prescribed for and used in pediatric patients. Some of these medications, such as antiglaucoma and dilating agents, have important potential systemic side effects, which mandate a risk-benefit analysis. The authors update the indications and dosages, as well as the data regarding efficacy and side effects in children of commonly used antibiotics, anti-inflammatory agents, and dilating and antiglaucoma medications.

The safety and efficacy of most commercially available medications have not been well studied in pediatric patients.[1] There is a particular paucity of information on drug use in patients under 2 years of age and many widely used drugs include disclaimers stating that safety and effectiveness in pediatric patients have not been established. Therefore, practitioners have had to prescribe many of these ophthalmic preparations empirically. In 1997, the U.S. Congress enacted a new law providing marketing incentives for pediatric drug studies as part of the Food and Drug Administration Modernization Act (Food and Drug Administration Modernization Act of 1997 [Page 111 STAT. 2296] Public Law 105-115. 105th Congress). This law is commonly known as the pediatric exclusivity provision because it provides an incentive of 6 months of marketing exclusivity of drugs covered by patent protection in return for conducting pediatric studies. The Best Pharmaceuticals for Children Act (Best Pharmaceuticals for Children Act, January 4, 2002 [Public Law No. 107-109]) was signed into law in early 2002. For those drugs no longer covered by patent and thus ineligible for exclusivity, the Best Pharmaceuticals for Children Act provides a new mechanism to help fund trials in children for a listing of candidate drugs to be updated annually until Act expiration in 2007. In 1999, the Pediatric Rule allowed the U.S. Food and Drug Administration (FDA) to require pediatric testing on new medications if the products were likely to be used in a substantial number of pediatric patients or would provide meaningful therapeutic benefit (Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; Final Rule U.S. Congress [63 FR 66632; Dec. 2, 1998]). The Pediatric Rule was challenged in court, and in 2002, a U.S. District Court ruled that the FDA did not have the authority to issue the Pediatric Rule and has barred the FDA from enforcing it. Subsequently, the Department of Health and Human Services announced that it would pursue rapid passage of legislation, giving the FDA authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on drugs and biologics.


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