BPCA has led to more than 200 drugs/therapeutics and 50 conditions/indications prioritized for further study. It also has led to more than 45 clinical trials funded to improve the knowledge of medicines used in children.
BPCA activities have produced 23 label changes to improve pediatric labeling (dosage, safety, and/or efficacy information). Access 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. Access 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. Access meropenem study description and details.
Mercy TAPE, a weight estimation device for children ages 2 to 16 years old, was the BPCA’s first device label, approved in May 2015. Access 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. Access Mercy BabyTAPE study description and details.
In response to results from a BPCA-funded Pediatric Trials Network (PTN) study 
, Lisinopril was relabeled in April 2016 to treat hypertension in children with renal transplants. Access lisinopril study description and details.
Lorazepam was relabeled in June 2016 based on BPCA-sponsored PK, safety, and efficacy trials. Access 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 also includes seizures as an adverse reaction. Access 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. Access lithium study description and details. Access 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. Access acyclovir study description and details. Access 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. Access the FDA Doxycycline Labels (Vibramycin (PDF 230 KB), Acticlate (PDF 617 KB), Doryx (PDF 744 KB), and Monodox (PDF 317 KB)) for more information. Access doxycycline study description and details. Access 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. Access caffeine citrate study description and details. Access Caffeine Citrate Study Summary (PDF 136 KB).
Clindamycin was relabeled in March 2020 to include clinical pharmacology and dosage information for children with obesity (clindamycin should be dosed based on total body weight). Access clindamycin obesity study description and details. Access 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. Access clindamycin safety study description and details.
Trimethoprim-Sulfamethoxazole (TMP-SMX) was relabeled in July 2020 to include pediatric PK data. Access TMP-SMX study description and details. Access the TMP-SMX Study Summary (PDF 203 KB).
Diazepam (injection) was relabeled in November 2021 to include dosing, safety, and PK data in children with status epilepticus. Access diazepam study description and details.
Rifampin was relabeled in February 2023 to include clinical pharmacology and adverse reactions for infants. Access rifampin study description and details.
Levetiracetam was relabeled in August 2023 to include dosing information in the PK section for pediatric patients with obesity. Access levetiracetam study description and details.
Fluconazole was relabeled in February 2024 to include PK dosing and safety data in preterm neonates. Access fluconazole study description and details.
Oxycodone was relabeled in April 2024 to include information from lactation studies conducted by the PTN that inform dosing and safety information on drugs taken during lactation and any potential effects on breastfed infants. Please visit the PTN website for more information on the Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE) study . Access oxycodone study description and details.
Oxcarbazepine was relabeled in September 2024 to include information from population PK modeling studies conducted by the PTN indicating that dosage adjustment according to obesity status is not necessary in pediatric patients who require this medication. Access oxcarbazepine study description and details.
Furosemide was relabeled in October 2024 to include pediatric PK data indicating the impact of body weight and postnatal age on furosemide clearance. Access furosemide study description and details.
Based on BPCA research, one additional study has been submitted to the FDA for label change consideration and is currently pending final review: metronidazole for dosing in newborns.
BACK TO TOP