Many drugs used in children today are used off-label, without adequate understanding of appropriate dose, safety, or efficacy. Over the years, results from the BPCA research program and clinical studies have led to several changes in medication labels—improving how medicines and medical devices are prescribed and used in newborns, infants, and children.
BPCA offers the following study summaries for researchers, healthcare providers, and parents who are interested in learning more about specific study results. Drugs with improved pediatric labeling as a result of the BPCA program’s efforts are marked with an asterisk. Some of the studies have been submitted to the U.S. Food and Drug Administration (FDA) for label change consideration and are marked as such within the document. Other studies have not yet been submitted to the FDA.
- Acyclovir* (PDF 142 KB)
- Caffeine Citrate* (PDF 136 KB)
- Clindamycin* (PDF 189 KB)
- Diazepam (PDF 126 KB)
- Doxycycline* (PDF 105 KB)
- Lithium* (PDF 103 KB)
- Trimethoprim-Sulfamethoxazole* (PDF 203 KB)