Food and Drug Administration (FDA) Postmarket Reported Side Effects and Adverse Events Associated with Pulmonary Hyperte
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ORIGINAL ARTICLE
Food and Drug Administration (FDA) Postmarket Reported Side Effects and Adverse Events Associated with Pulmonary Hypertension Therapy in Pediatric Patients Dawn M. Maxey • D. Dunbar Ivy • Michelle T. Ogawa Jeffrey A. Feinstein
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Received: 12 January 2013 / Accepted: 25 February 2013 Ó Springer Science+Business Media New York 2013
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 (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA
D. M. Maxey M. T. Ogawa J. A. Feinstein (&) Department of Pediatrics (Cardiology), Stanford University Medical Center/Lucile Packard Children’s Hospital, 750 Welch Road, Suite 305, Palo Alto, CA 94304, USA e-mail: [email protected] D. D. Ivy Division of Pediatric Cardiology, Department of Pediatrics, University of Colorado, 13123 E. 16th Avenue B100, Aurora, CO 80045-7106, USA
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. Keywords Adverse drug events Pediatrics Pulmonary hypertension
The Food and Drug Administration (FDA) mandates that adverse events be reported as part of pivotal trials leading to drug approval. After approval, drug manufacturers are required to continue submitting these reports. Consumers and health care professionals also are encouraged to report adverse events via the FDA’s MedWatch program. If at any point the FDA determines that a drug’s risks outweigh its benefits, regulatory action is taken to restrict the drug or remove it from the market. Over the past 10–15 years, several drugs have bee
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