PMID- 30222418
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200103
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 49
IP  - 2
DP  - 2015 Mar
TI  - Adverse Event Detection and Labeling in Pediatric Drug Development: 
      Antiretroviral Drugs.
PG  - 302-309
LID - 10.1177/2168479014565471 [doi]
AB  - BACKGROUND: Pediatric safety studies are conducted for drugs undergoing 
      development for use in pediatric patients. The objective of this study was to 
      describe safety studies and compare adverse events of antiretroviral drugs 
      between pediatric patients and adult subjects. METHODS: Pediatric and adult 
      adverse event data were obtained from US Food and Drug Administration 
      (FDA)-approved drug labels for 9 antiretroviral drugs with pediatric indications 
      approved by the FDA prior to 2013. For adverse events (AEs) reported in both 
      pediatric patients and adult subjects, the risk difference (RD) and associated 
      confidence interval (CI) were calculated. RESULTS: Of 35 drug-AE combinations, 10 
      AEs were reported at statistically significantly ( P < .05) higher incidence 
      rates in the pediatric population than in the adult population, and 3 AEs were 
      reported at statistically significantly higher rates in the adult population than 
      in the pediatric population. The largest differences where the risk of an AE was 
      greater in pediatric patients than in adult subjects were for rash with efavirenz 
      (RD = 36.24% [95% CI, 21.1 to 50.53]), diarrhea with efavirenz (RD = 24.53% [95% 
      CI, 9.06 to 39.57]), and rash with nevirapine (RD = 16.14% [95% CI, 9.7 to 
      24.27]). The largest differences where the risk of an adverse event was lower in 
      pediatric patients than in adult subjects were for headache with abacavir (RD = 
      -12% [95% CI, -16.81 to -6.89]), diarrhea with tipranavir (RD = -11.32% [95% CI, 
      -15.02 to -5.6]), and diarrhea with lamivudine (RD = -9.88% [95% CI, -15.91 to 
      -3.98]). CONCLUSIONS: The adult adverse event experience provides preliminary 
      data for pediatric drug safety, yet the specific types of adverse effects and 
      frequencies may not be predicted in children based exclusively on adults. As 
      adult safety data do not fully inform the pediatric safety profile, pediatric 
      safety studies should continue to be conducted separately for drugs undergoing 
      testing in pediatric patients.
FAU - Momper, Jeremiah D
AU  - Momper JD
AD  - 1 Skaggs School of Pharmacy and Pharmaceutical Sciences, University of 
      California, San Diego, La Jolla, CA, USA.
FAU - Chang, Yang
AU  - Chang Y
AD  - 2 Division of Bioequivalence, Office of Generic Drugs, US Food and Drug 
      Administration, Silver Spring, MD, USA.
FAU - Jackson, Matthew
AU  - Jackson M
AD  - 3 Office of Biostatistics, Office of Translational Sciences, US Food and Drug 
      Administration, Silver Spring, MD, USA.
FAU - Schuette, Paul
AU  - Schuette P
AD  - 3 Office of Biostatistics, Office of Translational Sciences, US Food and Drug 
      Administration, Silver Spring, MD, USA.
FAU - Seo, Shirley
AU  - Seo S
AD  - 4 Office of Clinical Pharmacology, Office of Translational Sciences, US Food and 
      Drug Administration, Silver Spring, MD, USA.
FAU - Younis, Islam
AU  - Younis I
AD  - 4 Office of Clinical Pharmacology, Office of Translational Sciences, US Food and 
      Drug Administration, Silver Spring, MD, USA.
FAU - Abernethy, Darrell R
AU  - Abernethy DR
AD  - 4 Office of Clinical Pharmacology, Office of Translational Sciences, US Food and 
      Drug Administration, Silver Spring, MD, USA.
FAU - Yao, Lynne
AU  - Yao L
AD  - 5 Division of Pediatric and Maternal Health, Office of New Drugs, US Food and 
      Drug Administration, Silver Spring, MD, USA.
FAU - Capparelli, Edmund V
AU  - Capparelli EV
AD  - 1 Skaggs School of Pharmacy and Pharmaceutical Sciences, University of 
      California, San Diego, La Jolla, CA, USA.
FAU - Burckart, Gilbert J
AU  - Burckart GJ
AD  - 4 Office of Clinical Pharmacology, Office of Translational Sciences, US Food and 
      Drug Administration, Silver Spring, MD, USA.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
OTO - NOTNLM
OT  - HIV
OT  - clinical trials
OT  - drug development
OT  - drug safety
OT  - pediatrics
EDAT- 2015/03/01 00:00
MHDA- 2015/03/01 00:01
CRDT- 2018/09/18 06:00
PHST- 2018/09/18 06:00 [entrez]
PHST- 2015/03/01 00:00 [pubmed]
PHST- 2015/03/01 00:01 [medline]
AID - 10.1177/2168479014565471 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2015 Mar;49(2):302-309. doi: 10.1177/2168479014565471.