Examples of PAC Suggestions for Further Studies
| Product | Safety Concern | Recommended Safety Studies |
|---|---|---|
| AndroGel (topical testosterone gel) for adult males | Inadvertent secondary exposure in children | Further 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 disorder | Metabolic effects and off-label use | Long-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 dermatitis | Carcinogenicity | Long-term cancer registry data and review of the literature with special concerns for off-label use in very young children |
| Sandostatin (octreotide acetate) for acromegaly | High 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 technology | Postmarketing 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 esophagitis | High off-label use in very young infants | Further 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 hemophilia | Used for rare diseases with very small sample size | Need 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 asthma | Increasing use in children <4 y | Recommended growth studies in young children, ages 0 to 4 y |
GERD, gastroesophageal reflux disease; NIH, National Institutes of Health.