Examples of PAC Suggestions for Further Studies

ProductSafety ConcernRecommended Safety Studies
AndroGel (topical testosterone gel) for adult malesInadvertent secondary exposure in childrenFurther assess effects of low-level secondary exposures and transfer of drug product from inanimate objects to people
Atypical antipsychotic agents for schizophrenia and irritability with autistic disorderMetabolic effects and off-label useLong-term studies including registries and active surveillance systems to evaluate metabolic syndrome, growth, sexual maturation, and hyperprolactinemia; information about on-label and off-label use
Topical calcineurin inhibitors as second-line therapy for atopic dermatitisCarcinogenicityLong-term cancer registry data and review of the literature with special concerns for off-label use in very young children
Sandostatin (octreotide acetate) for acromegalyHigh off-label use in neonates (eg, chylothorax)Recommended that the FDA work with the NIH regarding systematic, prospective, and retrospective reviews of actual off-label use and AEs
Apidra (insulin glulisine recombinant) and NovoLog (insulin aspart recombinant)Drug products administered with device technologyPostmarketing monitoring for AEs and medication errors for drug products used in association with device delivery systems; further study on device-related errors
Proton pump inhibitors for GERD and erosive esophagitisHigh off-label use in very young infantsFurther studies in the very young age group to understand risk/benefit profile and use of appropriate neonatal study end points
Kogenate FS (antihemophilic factor [recombinant]) used for hemophiliaUsed for rare diseases with very small sample sizeNeed to develop databases to identify pediatric use for products such as Kogenate FS, which are intended to treat rare diseases
Flovent HFA (fluticasone propionate) for asthmaIncreasing use in children <4 yRecommended growth studies in young children, ages 0 to 4 y
  • GERD, gastroesophageal reflux disease; NIH, National Institutes of Health.