Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review
Onabotulinumtoxin-A (onabotA) is a neurotoxin widely used for several indications, including chronic migraine (CM) preventive treatment, due to its well-demonstrated efficacy, tolerability, and safety. However, onabotA safety during pregnancy and breastfeeding remains unclear, as these populations a...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-04-01
|
| Series: | Toxins |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-6651/17/4/192 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850180830089969664 |
|---|---|
| author | Antonio Russo Luigi Francesco Iannone Ilaria Orologio Veronica Rivi Alberto Boccalini Flavia Lo Castro Marcello Silvestro Simona Guerzoni |
| author_facet | Antonio Russo Luigi Francesco Iannone Ilaria Orologio Veronica Rivi Alberto Boccalini Flavia Lo Castro Marcello Silvestro Simona Guerzoni |
| author_sort | Antonio Russo |
| collection | DOAJ |
| description | Onabotulinumtoxin-A (onabotA) is a neurotoxin widely used for several indications, including chronic migraine (CM) preventive treatment, due to its well-demonstrated efficacy, tolerability, and safety. However, onabotA safety during pregnancy and breastfeeding remains unclear, as these populations are typically excluded from clinical trials. The action of onabotA starts locally at the injection sites, modulating the pain pathway with minimal systemic absorption, which theoretically minimizes risks to the fetus or breastfeeding infant. Preclinical studies demonstrate that onabotA does not distribute systemically in significant amounts after administration, although adverse fetal outcomes in rats and rabbits were reported when injected at high doses. Limited human data suggest that onabotA exposure during pregnancy may not be associated with major malformations or significant adverse outcomes for the fetus, especially when used at therapeutic doses for migraine prevention during the first trimester or earlier. Data on breastfeeding are even scarcer but indicate a low likelihood of drug transfer into breast milk. This narrative review highlights the available evidence on the use of onabotA in pregnancy and breastfeeding women, including real-word evidence, with a focus on the use for CM. |
| format | Article |
| id | doaj-art-9dcf067f5a3249adbca713f6ffd53589 |
| institution | OA Journals |
| issn | 2072-6651 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj-art-9dcf067f5a3249adbca713f6ffd535892025-08-20T02:18:01ZengMDPI AGToxins2072-66512025-04-0117419210.3390/toxins17040192Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative ReviewAntonio Russo0Luigi Francesco Iannone1Ilaria Orologio2Veronica Rivi3Alberto Boccalini4Flavia Lo Castro5Marcello Silvestro6Simona Guerzoni7Antonio Russo Headache Center, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, 41124 Modena, ItalyAntonio Russo Headache Center, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, 41124 Modena, ItalyDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, 41124 Modena, ItalyDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, 41124 Modena, ItalyAntonio Russo Headache Center, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, 41124 Modena, ItalyOnabotulinumtoxin-A (onabotA) is a neurotoxin widely used for several indications, including chronic migraine (CM) preventive treatment, due to its well-demonstrated efficacy, tolerability, and safety. However, onabotA safety during pregnancy and breastfeeding remains unclear, as these populations are typically excluded from clinical trials. The action of onabotA starts locally at the injection sites, modulating the pain pathway with minimal systemic absorption, which theoretically minimizes risks to the fetus or breastfeeding infant. Preclinical studies demonstrate that onabotA does not distribute systemically in significant amounts after administration, although adverse fetal outcomes in rats and rabbits were reported when injected at high doses. Limited human data suggest that onabotA exposure during pregnancy may not be associated with major malformations or significant adverse outcomes for the fetus, especially when used at therapeutic doses for migraine prevention during the first trimester or earlier. Data on breastfeeding are even scarcer but indicate a low likelihood of drug transfer into breast milk. This narrative review highlights the available evidence on the use of onabotA in pregnancy and breastfeeding women, including real-word evidence, with a focus on the use for CM.https://www.mdpi.com/2072-6651/17/4/192Onabotulinumtoxin-Apregnancybreastfeedingchronic migrainesafetyfetal outcomes |
| spellingShingle | Antonio Russo Luigi Francesco Iannone Ilaria Orologio Veronica Rivi Alberto Boccalini Flavia Lo Castro Marcello Silvestro Simona Guerzoni Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review Toxins Onabotulinumtoxin-A pregnancy breastfeeding chronic migraine safety fetal outcomes |
| title | Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review |
| title_full | Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review |
| title_fullStr | Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review |
| title_full_unstemmed | Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review |
| title_short | Safety of Onabotulinumtoxin-A for Chronic Migraine During Pregnancy and Breastfeeding: A Narrative Review |
| title_sort | safety of onabotulinumtoxin a for chronic migraine during pregnancy and breastfeeding a narrative review |
| topic | Onabotulinumtoxin-A pregnancy breastfeeding chronic migraine safety fetal outcomes |
| url | https://www.mdpi.com/2072-6651/17/4/192 |
| work_keys_str_mv | AT antoniorusso safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT luigifrancescoiannone safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT ilariaorologio safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT veronicarivi safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT albertoboccalini safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT flavialocastro safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT marcellosilvestro safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview AT simonaguerzoni safetyofonabotulinumtoxinaforchronicmigraineduringpregnancyandbreastfeedinganarrativereview |