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FDA recommends against off-label sildenafil use in children

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REFERENCE

  1. FDA.FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension. Internet Document: 30 Aug 2012. Available from: URL: http://www.fda.gov

  2. Barst RJ, Ivy DD, Gaitan G, Szatmari A, Rudzinski A, Garcia AE, Sastry BKS, Pulido T, Layton GR, Serdarevic-Pehar M, Wessel DL.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, No. 2, 17 Jan 2012. Available from: URL: http://dx.doi.org/10.1161/CIRCULATIONAHA.110.016667

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FDA recommends against off-label sildenafil use in children. React. Wkly. 1418, 2 (2012). https://doi.org/10.2165/00128415-201214180-00004

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