Authors: Dawn M Maxey D Dunbar Ivy Michelle T Ogawa Jeffrey A Feinstein
Publish Date: 2013/03/27
Volume: 34, Issue: 7, Pages: 1628-1636
Abstract
Because most medications for pediatric pulmonary hypertension PH are used off label and based on adult trials little information is available on pediatricspecific 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 eg 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 literatureIn this example dyspepsia headache and insomnia have been associated with sildenafil anxiety with epoprostenol and chest pain with bosentan The remaining events of hemoptysis and muscle tightness are thus assumed to be associated with the targeted pulmonary hypertension medication
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