Abstract
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.
Highlights
Cyproheptadine (Periactine©) is a first-generation H1antihistamine drug, that was first distributed in the 1960s
Cyproheptadine is authorized for its orexigenic effect in adults and children above 2 years old in the United States
Over the 36 years of the analysis period, a total of 93 adverse effects (AEs) were reported in the French pharmacovigilance database (Table 2)
Summary
Cyproheptadine (Periactine©) is a first-generation H1antihistamine drug, that was first distributed in the 1960s. Its effect on appetite stimulation appeared as an interesting side effect [1, 2]. In 1994, Canadian authors first questioned this indication as most of the studies supporting this orexigenic effect had major methodologic flaws, and it was removed from the official recommendations [3]. In France, the last marketing authorization date was December 1997 for “allergic pathologies such as rhinitis, conjunctivitis, urticarial” in adults or children above 6 years old. In the 2000s, cyproheptadine was evaluated again in undernourished children with cancer, cystic fibrosis and Silver-Russell syndrome, with variable but interesting results [4,5,6]. Cyproheptadine is authorized for its orexigenic effect in adults and children above 2 years old in the United States. Cyproheptadine has been evaluated for functional digestive disorders and migraine prophylaxis [7, 8]
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