Flash Vig-news: The use of GLP-1 analogues following the new MHRA directives on the use of additional contraceptive measures

Advice following reports of unplanned pregnancies related to GLP-1 receptor agonists. An investigation by the EMA is currently ongoing.

• The Federal Agency for Medicines and Health Products (FAMHP) has taken note of new directives issued by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) concerning additional contraceptive measures for patients using GLP-1 receptor agonists. The MHRA recommends that women taking Mounjaro use non-oral forms of contraception for four weeks after starting treatment or after increasing their dose.

• In response to these guidelines from the MHRA, the FAMHP has been closely monitoring the views of the European Medicines Agency's (EMA) risk assessment team and rapporteurs for semaglutide (Switzerland) and tirzepatide (the Netherlands) concerning a potential signal linked to the efficiency of contraception in patients using GLP-1 receptor agonists.

• Currently, the product information of GLP-1 receptor agonists in the European Union (EU) indicates that the interactions with oral contraceptives are not considered to be clinically relevant. This information also indicates that these medicines should not be taken during pregnancy, when trying to get pregnant or while breastfeeding. Anyone who becomes pregnant while taking these medicines must discuss with their healthcare provider and stop the treatment as soon as possible. The effects of these medicines on the unborn child remain unknown. It is therefore recommended that contraception is used while taking these medicines.

• At this time, the FAMHP emphasises that no updated recommendations can be provided concerning the efficacy of oral contraceptives in patients taking these medicines. Furthermore, no recommendations can be provided regarding the possible need to use non-oral forms of contraception. As these products are authorised via the centralised procedure, any updates to the recommendations concerning their use in women of childbearing age must be discussed within the Pharmacovigilance Risk Assessment Committee (PRAC)

• The FAMHP will continue to rely on the PRAC's expertise and assessments, and will keep healthcare professionals and patients informed as new information becomes available.

References

• Reports in the media of cases of unplanned pregnancies with Ozempic and Mounjaro
  • Contraception warning over weight-loss drugs after dozens of pregnancies
  • MHRA urges women taking weight-loss drugs to use effective contraception - The Pharmaceutical Journal
• MHRA directive