USE OF SIBUTRAMINE IN PREGNANCY

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(Date of issue: August 2015, Version: 1.1)

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.

Summary

Sibutramine is a drug used for the treatment of obesity.  It affects the appetite control centre in the brain by inhibiting the reuptake of the neurotransmitters noradrenaline and serotonin.  In general, weight loss should not be attempted during pregnancy.  There are limited published data on the effects of sibutramine in human pregnancy.

There is concern about a possible association between weight loss in overweight women in early pregnancy and neural tube defects in the offspring based on data from studies on other appetite suppressants with similar modes of action.

No evidence of teratogenicity was seen in animal studies at doses of sibutramine that did not produce maternal toxicity.

Appetite suppressants are contraindicated during pregnancy.  Exposure to sibutramine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy.  In cases of abuse or long-term use during pregnancy, or if there is considerable weight loss in early pregnancy, a detailed fetal ultrasound is recommended to evaluate morphologic development, especially that of the neural tube.

Note: Due to the increased risk of cardiovascular events following use of sibutramine, the product license was suspended by the European Medicines Agency (EMA) in early 2010.

This product is no longer commercially available in the UK, therefore this document will not be updated.  If up-to-date information is required please contact UKTIS on 0844 892 0909.

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.