Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
Article date: April 2014
It is sometimes necessary for women to take medicines while pregnant. Some women may take medicines before they know they are pregnant. However, there is commonly little information available on a medicine’s effect on human pregnancy before the medicine is licensed. Therefore it is important to collect reports of suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy. This information improves our understanding of a medicine’s effect during pregnancy and informs treatment decisions to maximise the benefit and minimise the risk to the woman and child.
Update to online Yellow Card form
We have updated the online Yellow Card form to increase and improve reporting of suspected adverse reactions to medicines taken during pregnancy. When you enter data on a female 16 years or older, you will now be asked:
- If the woman is pregnant
- The dates of her last menstrual period if she is pregnant
- Expected date of delivery if she is pregnant
We also encourage you to provide the following in the “additional information” field of the Yellow Card:
- Information on previous pregnancies
- Dates and findings of ultrasonography
- If and when the woman started or stopped taking any other medicines and supplements during pregnancy (including folic acid)
If the suspected reaction is in the child, this helps us to identify when the fetus was exposed to the medicine and track the pregnancy outcome. We will request more detailed information if necessary (eg, details of any delivery complications, birth defects, or developmental concerns).
Please describe further details of congenital abnormalities following exposure to a medicine during pregnancy in the “additional information” field of the Yellow Card form.
Update to paper Yellow Card form
We are updating the paper Yellow Card forms. These are available at the back of the British National Formulary (BNF), in the Monthly Index of Medical Specialities (MIMS) or by electronic download from the MHRA website. We will publish a supporting guide on the MHRA and Yellow Card websites to help you report suspected adverse reactions experienced by the woman, fetus, or child following medicine use during pregnancy. In the meantime, please include any pregnancy-related information in the “additional information” section of the paper Yellow Card form.
Please continue to report to the Yellow Card Scheme
Thank you for continuing to send us your suspected adverse reaction reports. Every Yellow Card received is a valuable contribution to monitoring of the safety of medicines in the UK. In 2013, the majority of Yellow Card reports from healthcare professionals (72%) and members of the public (84%) were submitted electronically. Electronic Yellow Cards accounted for nearly 75% of all Yellow Cards received.
Please continue to report any suspected adverse reactions to us through the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard (if you choose to register, you can also keep track of any Yellow Cards that you send). Alternatively, prepaid paper Yellow Cards are available as summarised above. When reporting please provide as much information as possible, including information about pregnancy and postnatal outcomes, medical history, any concomitant medication, onset time of reaction, and treatment dates.