July 19 2018

The medicines regulator has issued a Drug Safety Update relating to suspected adverse drug reactions associated with medicines taken during pregnancy.

The MHRA is asking that any suspected ADRs, whether seen in the mother, baby or child, be reported using the Yellow Card scheme.  

“We are concerned that under-reporting in this important area may lead to missing drug safety signals, including miscarriage, congenital anomalies, or developmental disorders,” said the MHRA.

While “obstetricians and midwives have a particularly important role in providing data about pregnancy outcomes,” the MHRA has said: “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.”

If an ADR is suspected, as much information as can be gathered should be included the report, and where possible:

• the last menstrual period and expected date of delivery if the pregnancy is ongoing and dates when the medicine was taken;
• other medicines and/or vaccines taken during pregnancy (including folic acid, herbal medicines and/or any medicine obtained without a prescription), with dates;
• whether the mother has had her 20-week scan yet;
• 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);
• any complications at delivery (such as emergency caesarian section, foetal distress, or complications in the baby);
• details of any previous pregnancies and outcomes.

Link:
MHRA’s Drug Safety Update Yellow Card

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