OnabotulinumtoxinA for chronic migraine during pregnancy: a real world experience on 45 patients

Abstract

Objective To report the pregnancy outcomes on patients with chronic migraine exposed to onabotulinumtoxinA from Hull Headache Clinic. Background Migraines are common in women of reproductive age and those with chronic migraine have a major impact on their activities of daily living and health-related quality of life. Apart from low dose amitriptyline and beta-blockers all other prophylactic agents have proven teratogenic effects. OnabotulinumtoxinA is approved as preventive treatment for adult patients with chronic migraine, although its impact on pregnancy is unknown. Methods We prospectively collected data for efficacy and safety on all patients treated with onabotulinumtoxinA at the Hull Headache Clinic. The toxin is administered as per PREEMPT paradigm. Female patients of reproductive age group receiving onabotulinumtoxinA are given advice on contraception and the unknown impact of the toxin on pregnancy. They are asked to report pregnancy when they are appraised on the risk/benefit of treatment continuation. All patients are consented for access to their medical records and pregnancy outcome and those who wished to continue are asked to sign a disclaimer. Pregnancy outcome data was collected on all patients for the mode of delivery, birth weight and congenital malformation and any other unexpected outcomes. Results Over 9 years period 45 patients reported pregnancy while receiving onabotulinumtoxinA. All patients had received onabotulinumtoxinA within 3 months prior to the date of conception. 32 patients wished to continue treatment during pregnancy while the remaining 13 stopped treatment. Apart from 1 miscarriage in the treatment group, all patients had full term healthy babies of normal birth weight and no congenital malformations. Conclusion We report our experience of 45 patients exposed to onabotulinumtoxinA during pregnancy. Although the numbers are small, there was no impact of the toxin found on the pregnancy outcomes.

OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients with chronic migraine: a safety evaluation

“…However, this data derived from onabotA administration for movement disorders, esthetics and pain, not migraine prophylaxis. Wong et al reported the first prospective real-world study of pregnancy outcomes for onabotA in CM prophylaxis, in the Hull Migraine Clinic [75]. Over 9 years, 45 women received onabotA within 3 months prior to conception.…”

OnabotulinumtoxinA in Chronic Migraine: A Profile of Its Use

“…Against a background of inadequate data on the use of BoNT/A in pregnancy (see Table 1 ), outcomes in 45 pregnant CM patients exposed to BoNT/A have been reported recently [ 53 ]. Among the 32 patients that consented to continue treatment during their pregnancy, there was one miscarriage and 32 full-term deliveries of healthy newborns with normal birthweight and no congenital malformations [ 53 ].…”

OnabotulinumtoxinA for the treatment of headache: an updated review

“…A study conducted in a large pediatric headache center reported on a possible reversal of the underlying pathology when onabotulinumtoxinA was given as an adjunct to other preventive therapies, even when the disease was at its peak [52]. OnabotulinumtoxinA injections were also found to be safe during pregnancy, with no reported adverse effects on pregnancy outcomes [53].…”