EXPOSURE TO BOTULINUM TOXIN IN PREGNANCY

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(Date of issue: May 2018, Version: 3.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on botulinum toxin use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Botulinum toxin is produced by the bacterium Clostridium botulinum and is the cause of botulism, a potentially severe illness that can lead to paralysis and acute respiratory failure. Botulism may follow ingestion of food contaminated with botulinum toxin, from toxin production by C. botulinum present in the intestine or in wounds, or from inhalation of aerosolised toxin.

Botulinum toxin type A (BTX-A) is licensed for the treatment of blepharospasm, hemifacial spasm, idiopathic cervical dystonia, focal spasticity, bladder dysfunction, the prophylaxis of headaches in adults with severe migraine, and also in the management of severe axial hyperhidrosis. BTX-A is also used in aesthetic dermatology to temporarily improve the appearance of facial lines. Botulinum toxin type B (BTX-B) is licensed for the treatment of cervical dystonia.

There are limited data on which to base an assessment of the safety of exposure to botulinum toxin (either BTX-A or BTX-B) in human pregnancy. Animal studies of exposure to botulinum toxin type A have demonstrated teratogenic risk, however available data from human pregnancies exposed to Clostridium botulinum infection or to botulinum toxin type A do not suggest a significantly increased risk of congenital malformations or spontaneous abortion, although data are too limited to exclude any increase in risk. There are no data available on exposure to botulinum toxin type B on which to base an assessment of the risks following exposure in human pregnancy.

If botulism is suspected, due to the potential severity of the illness, treatment during pregnancy should be the same as for the non-pregnant patient. Data regarding maternal treatment with botulinum antitoxin are very limited but have not shown evidence of fetal harm, and where clinically indicated treatment with the antidote should not be withheld on account of pregnancy. Additional fetal monitoring may be warranted in cases of maternal botulism, particularly if exposure is associated with maternal hypoxia. Discussion with UKTIS is recommended in all cases.

Therapeutic use of botulinum toxin type A or B during pregnancy should be reserved for appropriate indications where no suitable alternative for treatment is available. The use of botulinum toxin for cosmetic indications during pregnancy should be avoided. Inadvertent exposure to botulinum toxin type A or B would not usually be regarded as medical grounds for any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.