Normal delivery following use of galcanezumab until the first and second trimesters of pregnancy: A report of 2 cases

RATIONALE: Clinical trials have demonstrated the efficacy, rapid action, and safety of calcitonin gene related peptide-related antibody drugs for migraine prevention, and subcutaneous galcanezumab was launched in Japan in April 2021. However, the safety of this drug in pregnant migraine patients has not been demonstrated in humans, with evidence of safety available only from animal studies. We report 2 cases in which subcutaneous galcanezumab was administered continuously until the first and second trimesters of pregnancy, resulting in normal births without any complications for either the mother or child. PATIENT CONCERNS: The cases involved pregnant patients, aged 34 and 43, with long-standing migraines without aura. DIAGNOSES: Migraines without aura. INTERVENTIONS: They were administered galcanezumab until the fifth week and fifth month of pregnancy, respectively. After discontinuation of treatment, the increase in the frequency of the mothers' migraines remained mild. OUTCOMES: Each mother safely gave birth to a baby boy, with acetaminophen administered as needed for the management of headaches. Subsequent checkups showed that both mothers and their children were healthy. LESSONS: The safety of galcanezumab administration in pregnant women has only been reported in scattered case reports, and further case studies are needed. It is considered necessary to continue to monitor newborns for the development of neurological abnormalities, including higher brain functions.