Pharmaceutical Regulatory Affairs: Open Access

Becker ML

Publications

• Review Article
  Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity
  Author(s): Zimmerman KO, Benjamin Jr. DK, Becker ML, Anand R and Hornik CPZimmerman KO, Benjamin Jr. DK, Becker ML, Anand R and Hornik CP
  
  Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early coll.. Read More»
  

  Abstract PDF