Abstract
Introduction: Isotretinoin is a form of vitamin A used to treat acne. It is the only therapy that has an impact on all of the major etiological factors implicated in acne [1]. Adults with growth hormone deficiency (which may result from problems with the pituitary gland or hypothalamus) may have symptoms including: poor bone density and osteoporosis, reduced muscle mass, fatigue, depression, and poor memory [2]. Objective: To assess the risk of blood growth hormone decrease associated with isotretinoin and, if necessary, make regulatory recommendations Methods: The Signal Detection team at SFDA performed a signal review using the National Pharmacovigilance Center (NPC) database and the WHO database, VigiBase, with literature screening to retrieve all related information to assess the causality between blood growth hormone decrease and isotretinoin use. The search was conducted on November 11th, 2021. The disproportionality of the observed and the expected reporting rates for drug/adverse drug reaction pair was estimated using an information component (IC), a tool developed by WHO-UMC to measure the reporting ratio. Positive IC reflects higher statistical association, while negative values indicate less statistical association. Results: Case Review: A search in the NPC database and WHO database (Vigibase) was conducted to retrieve all reported cases. There were five global ICSRs found, but no local ICSRs. The Signal Detection team applied the WHO-UMC causality assessment tool to all cases. 1 case was found supportive of the association, and 4 cases lacked the necessary information to assess causality. Datamining: The results of (IC = 2.7) revealed a positive statistical association for the drug/ADR combination. Literature: In 2015, a pre-and post-exposure study was published. The effects of various isotretinoin dosing regimens on pituitary hormones in drug recipients were studied. Blood samples were taken before the start of treatment and three months later. Growth hormone levels were found to be significantly lower (p = 0.002) [3]. Conclusion: The weighted cumulative evidence identified from global cases, literature and datamining is sufficient to suggest a causal association between isotretinoin and a decrease in blood growth hormone. Despite the need for a more thorough review of safety data to confirm the risk, health care professionals should be aware of the potential risk in drug recipients and monitor signs of blood growth hormone decrease.