Diagnosis and Management of Infantile Hemangioma

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H-12 Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
Harms Data for Medications Included in the Analysis The following sections provide an overview of the common and notable adverse events of each medication. When possible, adverse event data specific for pediatric patients have been included. It is important to note that the information provided in this section is not an allinclusive list of adverse events. Consult the corresponding package insert for complete information. Many of the adverse events reported are from various clinical trials used in support of the medication’s FDA approval. As a result, these trials many have been conducted under varying conditions and the adverse event rates may not reflect what is observed in clinical practice. In addition, these rates may not necessarily be able to be compared to the rates observed in the clinical trials of different drugs. Post-marketing adverse events are reported on a voluntary basis and therefore do not represent complete patient data. Hemangeol® (propranolol hydrochloride) Hemangeol® is the only medication included in this review that has an FDA approved indication for infantile hemangioma. The safety of Hemageol® in pediatric patients has been reported in the medication package insert. 1 FDA medical review packages were not available for this medication. The most common adverse events, occurring in greater than 10% of infants, were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. 1 In a study of pooled safety data (n=424), infants (63% aged 91-150 days) were treated with Hemangeol® 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Treatment emergent adverse events occurring in 3% or greater in infants receiving the Hemangeol® 1.2 mg/kg/day (n=200) or Hemangeol® 3.4 mg/kg/day (n=224) compared to placebo were provided. Adverse events and frequencies for patients receiving Hemangeol® 1.2 mg/kg/day included: sleep disorders (17.5%), bronchitis (8%), peripheral coldness (8%), agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%), irritability (5.5%), decreased appetite (2.5%), and abdominal pain (3.5%). Adverse events and frequencies for patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders (16.1%), bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%), somnolence (0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), and abdominal pain (0.4%). Additional adverse events reported in less than 1% of patients participating in clinical trials included: second degree atrioventricular heart block (occurring in a patient with underlying conduction disorder), urticaria, alopecia, decreased blood glucose, and decreased heart rate. Additional Formulations The safety and efficacy of the oral tablet, oral capsule, and injectable formulations of propranolol have not been investigated in pediatric patients. 18-20 The package inserts for these formulations state that reports of bronchospasm and congestive heart failure have been reported in pediatric patients receiving propranolol. Post-marketing Adverse Events Additional adverse events revealed during post-marketing surveillance include: agranulocytosis, hallucination and purpura. 1 H-13
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Comparative Effectiveness Review Nu
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This report is based on research co
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Acknowledgments The authors gratefu
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Peer Reviewers Prior to publication
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BCI; moderate SOE for effects of pr
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Overview of the Literature ........
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Executive Summary Introduction Infa
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for contextual questions as few eff
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Figure B. Analytic framework for KQ
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Table A. Inclusion criteria (contin
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precision (precise, imprecise), and
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Figure D. Estimates of expected IH
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majority of studies to date have in
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effectiveness outcomes. The evidenc
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changes. We considered the strength
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Table C. Summary of evidence in stu
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Table D. Summary of evidence in stu
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Applicability We set inclusion crit
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quantitative meta-analyses. Researc
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surgically. Lesion characteristics
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References 1. Wassef M, Blei F, Ada
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39. Yu L, Li S, Su B, et al. Treatm
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modalities. The questions of imagin
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KQ2. Among newborns, infants, and c
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of data, and compiling evidence. We
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We only included studies published
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a standardized form (Appendix B) th
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Determining Quality Ratings • We
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Results We present results for Cont
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defects, urogenital anomalies, ulce
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Results of Literature Searches for
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Table 3. Characteristics of include
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scans, had a sensitivity of 20 perc
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of the model fit to all studies, bu
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Detailed Analysis Effectiveness of
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Table 6. Key resolution outcomes in
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with prednisolone included endocrin
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children in 8 studies), skin atroph
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hypopigmentation, impaired wound he
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fair quality for effectiveness outc
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studies of nadolol and atenolol. No
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Table 10. Key resolution outcomes i
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old. 100 Thirty percent of children
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Table 11. Resolution outcomes in st
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Table 15. Key outcomes in studies c
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Table 22. Harms/adverse effects in
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Table 24. Adverse effects in case s
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Table 24. Adverse effects in case s
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• In two RCTs reporting level of
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Nd:YAG Laser With Cooling Compared
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long term follow information was av
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Discussion State of the Literature
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Table 34. Strength of evidence for
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Effectiveness and Harms of Beta-Blo
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older children. One comparative stu
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case series reporting on rarer pres
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agents is critical, especially as u
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References 1. Wassef M, Blei F, Ada
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39. Chen TS, Eichenfield LF, Friedl
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80. Mai HM, Zheng JW, Wang YA, et a
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119. Sharma LK, Dalal SS. Corticost
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162. Snir M, Reich U, Siegel R, et
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198. Chen ZG, Zheng JW, Yuan ML, et
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237. Healy G, McGill T, Friedman EM
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Abbreviations and Acronyms Used in
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Appendix A. Search Strategies Searc
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Searches for Comparative Effectiven
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Appendix B. Screening and Quality A
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Harms Risk of Bias Assessment Form
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QUADAS Diagnostic Accuracy Rating T
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Infantile Hemangioma CER: Risk of B
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20. Grundfest-Broniatowski S, Carey
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65. Dachman AH, Lichtenstein JE, Fr
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111. Yoshida T, Kuratomi K, Mitsuma
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160. Newman SL, Goodwin CD. Colonic
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204. Crockett DM, Healy GB, McGill
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253. Wright GL, Smith RJ, Katz CD,
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301. Paley D, Jackson RW. Synovial
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346. Dombrowski MP, Budev H, Wolfe
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390. Stringel G. Giant hemangioma:
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436. Liu HC, Chang MH, Lue HC, et a
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480. Casale AJ, Menashe DS. Massive
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526. Taylor RS, Joseph DB, Kohaut E
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571. Goldstein MH. The elastic flap
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614. Salloum E, Flamant F, Caillaud
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793. Van Campenhout I, Patriquin H.
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880. Schulman SR, Jones BR, Slotnic
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924. Egawa H, Berquist W, Garcia-Ke
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968. Thompson DN, Taylor WF, Haywar
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1013. Gregg CM, Wiatrak BJ, Koopman
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1056. Rozylo TK, Krupski W, Galkows
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2953. Nonogaki S, Campos HGA, Butug
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2995. Storch CH, Hoeger PH. Propran
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3038. Al Dhaybi R, Superstein R, Mi
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3159. Kolokythas A, Al-Ghamian H, M
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3201. Nale P. Propranolol treatment
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3243. Soltani AM, Reinisch JF. Algo
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3286. . Derm Dx. Clinical Advisor.
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3326. Chang YT, Lin JY, Lee JY, et
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3732. Stiles JM, Amaya C, Rains S,
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3772. Zou HX, Jia J, Zhang WF, et a
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Page 373 and 374: Figure D-1. Estimates of expected I
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Page 397 and 398: 25. Qiu Y, Ma G, Yang J, et al. Imi
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Page 403 and 404: 120. Pandey A, Gangopadhyay AN, Gop
Page 405 and 406: Appendix G. Applicability Tables Ta
Page 407 and 408: Appendix H. Harms Reported in Packa
Page 409 and 410: o Acquired (autoimmune) hemolytic a
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Page 415 and 416: Elocon® (mometason e furoate) 11 T
Page 417: Timoptic® (timolol maleate) 15 Tim
Page 421 and 422: Table H-3: Adverse Events from Flo-
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Page 425 and 426: thromboembolism, thrombophlebitis,
Page 427 and 428: grades): 103 (48%), erosion/ulcerat
Page 429 and 430: acute myocardial infarction: 3 (Rat
Page 431 and 432: Discontinuations Patients utilizing
Page 433 and 434: ocular irritation including blephar
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Diagnosis and Management of Infantile Hemangioma

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