Anyone completing an online Yellow Card form relating to a woman aged 16 years or older will now be asked whether she is pregnant and if applicable, the dates of her last menstrual period and her expected date of delivery.
People completing the form are also encouraged to provide the following information in the 'additional information' field:
- information on previous pregnancies
- dates and findings of ultrasonography
- if and when the woman started or stopped taking any other medicines or supplements, including folic acid, during pregnancy
The MHRA states that if the suspected adverse reaction is in the child this information will help to identify when the foetus was exposed to the medicine and to track the pregnancy outcome. If necessary the MHRA will request any further information, such as details of any delivery complications, birth defects or developmental concerns.
Further details of any congenital abnormalities in a child exposed to a medicine during pregnancy should also be recorded in the additional information field.
The paper Yellow Card forms are in the process of being updated and the MHRA requests that in the meantime, any pregnancy-related information is entered in the additional information field.