Medicines taken during pregnancy: please report suspected adverse drug reactions, including in the baby or child, on a Yellow Card
Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child. Obstetricians and midwives have a particularly important role in providing data about pregnancy outcomes – your reports are essential to improving understanding of the safety of medicines for women and children.
Medicines in pregnancy
Medicines should not be taken in pregnancy unless absolutely necessary. However, some women with serious illnesses will need to take medicines to protect their health and that of the baby.
We are concerned that under-reporting in this important area may lead to missing drug safety signals, including miscarriage, congenital anomalies, or developmental disorders.
We welcome reports from those in the field of obstetrics such as obstetricians and midwives, who are able to provide key information such as results from prenatal scans and background information surrounding a pregnancy, which greatly contribute to post-marketing safety assessment of medicines.
Why is it important to report effects from use of medicines in pregnancy?
The Yellow Card Scheme is the UK system for monitoring the safety of medicines and healthcare products to ensure that they are acceptably safe for use by patients.
When a medicine is licensed, there is often limited information on effects from use in pregnancy. Therefore, information about medicines used during pregnancy and any suspected adverse drug reactions in the mother or child is essential to improve our understanding of a medicine’s effect during pregnancy and ensure that healthcare professionals have up-to-date information on risks.
Reporting is the most common source of post-licensing data available on the safety of medicines used during pregnancy, and the most common evidence base for taking restrictive regulatory action.
Any patients, caregivers, or healthcare professionals, including midwives and obstetricians, can report a Yellow Card when they suspect a medication used during pregnancy has caused an adverse reaction or abnormal pregnancy outcome. Reports should also be made when an adverse effect associated with a medicine is suspected in a pregnancy that was not carried to term.
What to report?
For cases concerning exposure during pregnancy, the reporter will be asked to tick a checkbox if the patient is pregnant. It is important to provide as much information as possible in relation to the suspected adverse reaction in the mother or child.
We also encourage you to include the following, where available:
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Last menstrual period and expected date of delivery if the pregnancy is ongoing and dates when the medicine was taken
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Other medicines and/or vaccines taken during pregnancy (including folic acid, herbal medicines and/or any medicine obtained without a prescription), with dates
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Whether the mother has had her 20-week scan yet
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Details of any maternal medical history/current maternal medical condition relevant to this pregnancy (this can include details such as IVF conception and antenatal scans, any other significant events during the pregnancy)
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Any complications at delivery (such as emergency caesarian section, fetal distress, or complications in the baby)
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Details of any previous pregnancies and outcomes
Some suspected adverse reactions due to exposure during pregnancy may not be noticeable until later in the child’s life. These types of reports are also extremely important to submit.
How to report?
You can report Yellow Cards for all medicines, on the Yellow Card website.
You can also report suspected adverse reactions to medicines:
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via the free Yellow Card app; download now from the Apple App Store or Google Play Store
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through some clinical IT systems (SystmOne/Vision/MiDatabank)
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by phone: 0800 731 6789 (freephone number, 10am to 2pm Monday-Friday)
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using forms in the BNF, MIMS, or PAGB OTC directory
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by downloading forms from the Yellow Card website and sending them freepost to ‘Yellow Card’
MHRA may request more detailed information and follow-up about the outcomes of the pregnancy as necessary. Therefore, when reporting, please provide sufficient contact information to allow for this.
More information for healthcare professionals can be found on the MHRA website.
If in doubt as to whether to report a suspected adverse drug reaction, please complete a Yellow Card. Please do not assume someone else has reported it. Your Yellow Card report makes a difference to improving patient safety.
Article citation: Drug Safety Update volume 11, issue 12; July 2018: 5.