Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy

Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.

New Safer Medicines in Pregnancy and Breastfeeding Consortium

On 11 January 2021, the MHRA and partner organisations launched a major new initiative to ensure pregnant and breastfeeding women can make informed decisions about their healthcare, particularly relating to the medicines they take.

The Safer Medicines in Pregnancy and Breastfeeding Consortium is a partnership of 16 leading organisations working together to improve the health information available to women who are thinking about becoming pregnant, are pregnant, or are breastfeeding. The partnership includes the NHS, regulators, and leading third sector and charitable organisations.

To support this work, we ask healthcare professionals to report important inconsistencies in UK advice on use of individual or classes of medicines used in pregnancy or breastfeeding via the address on the consortium’s webpage.

For more information on the consortium and its information strategy see the Guidance page.

We also have a new guidance page to assist users in finding MHRA information and projects related to medicines use in pregnancy and breastfeeding.

Optimising data on medicines used during pregnancy

The launch of the consortium coincides with the publication of a Report of the Commission on Human Medicines Expert Working Group on Optimising Data on Medicines used During Pregnancy.

The report provides recommendations on ways in which data on medicines used in pregnancy and breastfeeding can be better collected and made available for analysis. This will enable more robust evidence to be generated through research and will be important in helping to develop clear and consistent advice about medicines used during pregnancy and breastfeeding.

Recommendations of the report include the better capture and linking of existing data, exploring new ways to collect relevant information on exposure to medicines during pregnancy and breastfeeding, and improving access to and quality of data to further enable research.

Report on a Yellow Card

Please continue to report any suspected adverse drug reactions (ADRs) associated with medicines taken during pregnancy or breastfeeding experienced by the woman and any suspected effects on the baby or child.

All patients, caregivers, and healthcare professionals can report a Yellow Card when they suspect a medication used during pregnancy has caused an adverse reaction or adverse pregnancy outcome.

When reporting ADRs related to medicines used in pregnancy, the following information is particularly valuable for our assessment of the report:

  • Timings of when the medicine was taken during the pregnancy
  • The outcome of the pregnancy (when known)
  • Details of any relevant family history, including any obstetric history
  • Detailed clinical descriptions and the results of any imaging (for example, scans), or laboratory tests

Please include any other relevant information; including other medications or substances taken during the pregnancy, as well as folic acid intake.

Report Yellow Cards using:

Report suspected side effects to medicines, vaccines or medical device and diagnostic adverse incidents used in coronavirus (COVID-19) using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.

Article citation: Drug Safety Update volume 14, issue 7: February 2021: 4.

Published 18 February 2021