Food and drug administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients

Pediatric Cardiology

Volumn 34, Issue 7, 2013, Pages 1628-1636

  Maxey, Dawn M ^a   Ivy, D Dunbar ^b   Ogawa, Michelle T ^a   Feinstein, Jeffrey A ^a  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b University of Colorado Denver and Children s Hospital Colorado   (United States)

Author keywords

Adverse drug events; Pediatrics; Pulmonary hypertension

Indexed keywords

BOSENTAN; PROSTACYCLIN; SILDENAFIL;

ADOLESCENT; ADULT; ARTICLE; BILIRUBIN BLOOD LEVEL; CHILD; CHILDHOOD DISEASE; CHILDHOOD MORTALITY; CONVULSION; CORONARY ARTERY DISEASE; COUGHING; CYANOSIS; DISEASE ASSOCIATION; DRUG FATALITY; DRUG SAFETY; DYSPNEA; EXERCISE TOLERANCE; FAINTNESS; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART ARREST; HEART FAILURE; HEART RIGHT VENTRICLE FAILURE; HEMOPTYSIS; HUMAN; HYPOTENSION; HYPOXIA; INFANT; INFORMATION PROCESSING; LIVER FUNCTION TEST; LUNG HEMORRHAGE; MAJOR CLINICAL STUDY; MALE; MEDICAL LITERATURE; MONOTHERAPY; OXYGEN SATURATION; PLEURA EFFUSION; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRESCHOOL CHILD; PULMONARY HYPERTENSION; RESPIRATORY FAILURE; SCHOOL CHILD; SIDE EFFECT; STRIDOR; THROMBOCYTOPENIA;

ADOLESCENT; ANTIHYPERTENSIVE AGENTS; CHILD; CHILD, PRESCHOOL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EPOPROSTENOL; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYPERTENSION, PULMONARY; INCIDENCE; INFANT; INFANT, NEWBORN; MALE; PIPERAZINES; PRODUCT SURVEILLANCE, POSTMARKETING; PURINES; RETROSPECTIVE STUDIES; SULFONAMIDES; SULFONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASODILATOR AGENTS;

EID: 84885388217     PISSN: 01720643     EISSN: 14321971     Source Type: Journal    
DOI: 10.1007/s00246-013-0688-2     Document Type: Article

References (10)

1. Abman S (2010) Pulmonary hypertension in children: a historical overview. Pediatr Crit Care Med 11(2 Suppl):S4-S9
2. Adverse Event Reporting System (AERS) (2006) Background report definitions, and caveats. Department of Health and Human Services
3. Barst RJ et al (2006) Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J 28:1195-1203
4. Barst RJ, Layton G, Konourina I, Richardson H, Beghetti M, Ivy DD (2012) STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive patients with pediatric pulmonary arterial hypertension. Eur Heart J 33(Suppl 1):979
5. Barst RJ et al (2012) A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naive children with pulmonary arterial hypertension. Circulation 125:324-334
6. Cassens BJ (2010) Warning letters. Actelion Pharmaceuticals U.S., Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm227632.htm. Accessed 1 Jun 2011
7. FDA (2012) FDA drug safety communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension. http://www.fda.gov/Drugs/DrugSafety/ucm317123.htm. Accessed 10 Jan 2013
8. Gilead Sciences (2007) I. U.S. Food and Drug Administration approves Gilead's Letairis™ (ambrisentan) 5 mg and 10 mg tablets for the once-daily treatment of pulmonary arterial hypertension (WHO group 1) in patients with WHO functional class II or III symptoms. http://www.gilead.com/wt/sec/pr-1016053. Accessed 1 Jun 2011
9. McLaughlin VV et al (1998) Reduction in pulmonary vascular resistance with long-term epoprostenol (prostacyclin) therapy in primary pulmonary hypertension. New Engl J Med 338:273-277
10. United Therapeutics (2009) FDA approves adcirca (Tadalafil) tablets for the treatment of pulmonary arterial hypertension. http://ir.unither.com/ releasedetail.cfm?. Accessed 1 Jun 2011