PMID- 23532466
OWN - NLM
STAT- MEDLINE
DCOM- 20140429
LR  - 20240318
IS  - 1432-1971 (Electronic)
IS  - 0172-0643 (Print)
IS  - 0172-0643 (Linking)
VI  - 34
IP  - 7
DP  - 2013 Oct
TI  - Food and Drug Administration (FDA) postmarket reported side effects and adverse 
      events associated with pulmonary hypertension therapy in pediatric patients.
PG  - 1628-36
LID - 10.1007/s00246-013-0688-2 [doi]
AB  - Because most medications for pediatric pulmonary hypertension (PH) are used off 
      label and based on adult trials, little information is available on 
      pediatric-specific adverse events (AEs). Although drug manufacturers are required 
      to submit postmarket AE reports to the Food and Drug Administration (FDA), this 
      information is rarely transmitted to practitioners. In the setting of a recent 
      FDA warning for sildenafil, the authors sought to give a better description of 
      the AEs associated with current therapies in pediatric PH. In January 2010, a 
      written request was made to the Food and Drug Administration for AE records of 
      commonly used PH medications. Reports were screened for pediatric patients, 
      analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, 
      AEs that could be attributed to concomitant medications were not attributed to 
      the PH medication in question. Adverse events occurring in more than 5 % of 
      events for each drug were assumed to be associated with the targeted PH 
      medication. Between November 1997 and December 2009, 588 pediatric AE reports 
      (death in 257 cases) were reported for the three most commonly used therapies: 
      bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those 
      reported previously. However, 27 AEs not previously reported in the literature 
      (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA 
      postmarket records for PH medications in pediatric patients show a significant 
      number of AEs. The discovery of AEs not previously reported will better inform 
      those caring for these complex and critically ill children, and the large number 
      of deaths suggest they may be underreported in current literature.
FAU - Maxey, Dawn M
AU  - Maxey DM
AD  - Department of Pediatrics (Cardiology), Stanford University Medical Center/Lucile 
      Packard Children's Hospital, 750 Welch Road, Suite 305, Palo Alto, CA, 94304, 
      USA.
FAU - Ivy, D Dunbar
AU  - Ivy DD
FAU - Ogawa, Michelle T
AU  - Ogawa MT
FAU - Feinstein, Jeffrey A
AU  - Feinstein JA
LA  - eng
GR  - UL1 TR000154/TR/NCATS NIH HHS/United States
GR  - UL1 TR001082/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20130327
PL  - United States
TA  - Pediatr Cardiol
JT  - Pediatric cardiology
JID - 8003849
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfonamides)
RN  - 0 (Sulfones)
RN  - 0 (Vasodilator Agents)
RN  - BW9B0ZE037 (Sildenafil Citrate)
RN  - DCR9Z582X0 (Epoprostenol)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Adolescent
MH  - Antihypertensive Agents/adverse effects/*therapeutic use
MH  - Bosentan
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Epoprostenol/adverse effects/therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy
MH  - Incidence
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Piperazines/adverse effects/therapeutic use
MH  - Product Surveillance, Postmarketing/*methods
MH  - Purines/adverse effects/therapeutic use
MH  - Retrospective Studies
MH  - Sildenafil Citrate
MH  - Sulfonamides/adverse effects/therapeutic use
MH  - Sulfones/adverse effects/therapeutic use
MH  - United States/epidemiology
MH  - United States Food and Drug Administration/*statistics & numerical data
MH  - Vasodilator Agents/adverse effects/*therapeutic use
PMC - PMC3783558
MID - NIHMS506694
EDAT- 2013/03/28 06:00
MHDA- 2014/04/30 06:00
PMCR- 2013/10/01
CRDT- 2013/03/28 06:00
PHST- 2013/01/12 00:00 [received]
PHST- 2013/02/25 00:00 [accepted]
PHST- 2013/03/28 06:00 [entrez]
PHST- 2013/03/28 06:00 [pubmed]
PHST- 2014/04/30 06:00 [medline]
PHST- 2013/10/01 00:00 [pmc-release]
AID - 10.1007/s00246-013-0688-2 [doi]
PST - ppublish
SO  - Pediatr Cardiol. 2013 Oct;34(7):1628-36. doi: 10.1007/s00246-013-0688-2. Epub 
      2013 Mar 27.