BPCA has led to more than 150 drugs/therapeutics and 50 conditions/indications prioritized for further study. It has also led to more than 30 clinical trials funded to improve the knowledge of medicines used in children.
BPCA activities have produced 16 label changes to improve pediatric labeling (dosage, safety, and/or efficacy information). View a selection of approved labels on the U.S. Food and Drug Administration (FDA) website.
The first label change was for the drug propylthiouracil. NICHD sponsored a workshop in October 2008 that reviewed epidemiology and adverse event data that showed a 10-fold risk of liver damage in patients treated with this drug. Based on the results of this meeting, the FDA issued a "Dear Doctor" letter to health care professionals on June 4, 2009, outlining the risk of serious liver injury with the use of this drug in adult and pediatric patients.
The second label change was for the drug pralidoxime. Based on BPCA prioritization, this drug was relabeled for pediatric use in September 2010.
Sodium nitroprusside was relabeled in December 2013 for pediatric use based on BPCA-sponsored pharmacokinetic (PK), safety, and efficacy trials. View the FDA Sodium Nitroprusside Label (PDF 65.9 KB) for more information. View sodium nitroprusside study description and details.
Meropenem was relabeled in December 2014 for the treatment of pediatric intra-abdominal infections based on BPCA-sponsored PK, safety, and efficacy trials. View the FDA Meropenem Label (PDF 225 KB) for more information. View meropenem study description and details.
Mercy TAPE, a weight estimation device for children ages 2-16 years, was the BPCA’s first device label, approved in May 2015. View Mercy TAPE study description and details.
Mercy BabyTAPE, a similar device for infants from birth through 90 days of age, was approved in September 2019. View Mercy BabyTAPE study description and details.
In response to results from a BPCA-funded Pediatric Trials Network study, Lisinopril was relabeled in April 2016 to treat hypertension in children with renal transplants.
Lorazepam was relabeled in June 2016 based on BPCA-sponsored PK, safety, and efficacy trials. View the FDA Lorazepam Label (PDF 303 KB) for more information. View lorazepam study description and details.
Ampicillin was relabeled in February 2018 to include neonatal dosing for meningitis and septicemia based on neonatal gestational age at birth and postnatal day of life. The new FDA Ampicillin Label (PDF 83 KB) also includes seizures as an adverse reaction. View ampicillin study description and details.
Lithium was relabeled in October 2018 based on BPCA-sponsored clinical trials that evaluated the dosing as well as the short and long-term safety and effectiveness of lithium to treat bipolar disease in children. View the FDA Lithium Label (PDF 344 KB) for more information. View lithium study description and details. View the Lithium Study Summary (PDF 103 KB).
Acyclovir was relabeled in January 2019 for use in neonates up to 3 months old, based on an observational, retrospective study that included analysis of safety data. View the FDA Acyclovir Label (PDF 354 KB) for more information. View acyclovir study description and details. View the Acyclovir Study Summary (PDF 142 KB).
Doxycycline was relabeled in March 2020 to include pediatric data in the PK subsection of the clinical pharmacology section of the label. View the FDA Doxycycline Labels (Vibramycin (PDF 230 KB), Acticlate (PDF 617 KB), and Doryx (PDF 744 KB)) for more information. View doxycycline study description and details. View the Doxycycline Study Summary (PDF 105 KB).
Caffeine citrate was relabeled in March 2020 to include a broader gestational age range of premature infants and longer treatment duration. View the FDA Caffeine Citrate Label (PDF 284 KB) for more information. View caffeine citrate study description and details. View Caffeine Citrate Study Summary (PDF 136 KB).
Clindamycin was relabeled in March 2020 to include clinical pharmacology and dosage information for obese children (clindamycin should be dosed based on total body weight). View the FDA Clindamycin Labels with dosing update for obesity (Cleocin Injection (PDF 509 KB) and Cleocin Capsules (PDF 311 KB)) for more information. View clindamycin obesity study description and details. View the Clindamycin (dosing for children with obesity) Study Summary (PDF 189 KB)
Clindamycin was relabeled again in December 2021 to include safety data for infants with complicated abdominal infections. View clindamycin safety study description and details.
Trimethoprim-Sulfamethoxazole (TMP-SMX) was relabeled in July 2020 to include pediatric pharmacokinetic data. View the FDA TMP-SMX Labels (Bactrim Tablets (PDF 469 KB) and Bactrim Pediatric Suspension (PDF 252 KB)) for more information. View TMP-SMX study description and details. View the TMP-SMX Study Summary (PDF 203 KB).
Based on BPCA research, two additional studies have been submitted to the FDA for label change consideration and are currently pending final review: diazepam dosing and safety in children and fluconazole dosing and safety in preterm neonates.