| アブストラクト | Objectives: Cyproheptadine is a first-generation H1-antihistamine drug first that was distributed in the 1960s. While its orexigenic effect was observed early, cyproheptadine is not yet authorized for this indication in all countries today. There is an increasing medical interest and demand for the orexigenic effect of cyproheptadine, especially in children with poor appetite. As cyproheptadine might be evaluated in future clinical trials, we wanted to assess its safety profile. Methods: Using the French national pharmacovigilance database, we retrospectively analyzed all pediatric and adult reports of adverse effects of cyproheptadine recorded since its first distribution in France. Next, we performed a systematic review of the literature of cyproheptadine adverse effects. Results: Since 1985, 93 adverse effects were reported in the French pharmacovigilance database (adults 81.7%, children 18.3%); these were mainly neurological symptoms (n = 38, adults 71%, children 28.9%), and hepatic complications (n = 15, adults 86.7%, children 13.3%). In the literature, the most frequent adverse effect reported was drowsiness in adults or children, and five case reports noted liver complications in adults. We estimated the frequency of hepatic adverse effects at 0.27 to 1.4/1000, regardless of age. Conclusion: Cyproheptadine can be considered a safe drug. Mild neurological effects appear to be frequent, and hepatotoxicity is uncommon to rare. Randomized controlled trials are needed to evaluate the safety and efficacy of cyproheptadine before authorization for appetite stimulation, especially in young children as studies at this age are lacking. Possible hepatic complications should be monitored, as very rare cases of liver failure have been reported. |
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| ジャーナル名 | Frontiers in pediatrics |
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| Pubmed追加日 | 2021/10/23 |
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| 投稿者 | Bertrand, Valerie; Massy, Nathalie; Vegas, Nancy; Gras, Valerie; Chalouhi, Christel; Tavolacci, Marie-Pierre; Abadie, Veronique |
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| 組織名 | Department of Pediatrics, Le Havre Hospital, Le Havre, France.;Regional Center of Pharmacovigilance, Rouen University Hospital, Rouen, France.;General Pediatrics Unit, Necker University Hospital, Paris, France.;Refferal Center for Rare Disease << Pierre Robin Sequence and Sucking and;Swallowing Congenital Disorders >>, Necker University Hospital, Paris, France.;Regional Center of Pharmacovigilance, Amiens University Hospital, Amiens, France.;CIC104 Rouen University Hospital and INSERM 1073, Rouen, France.;Paris University, Paris, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34676184/ |
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