Other safety alerts
|
| |
| The United Kingdom: Metformin in pregnancy: Study shows no safety concerns |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that a large study has shown no safety issues of concern relating to the use of metformin during pregnancy.
Uncontrolled hyperglycaemia in the time around conception (periconceptional phase) and during pregnancy is associated with increased risks to the baby and the patient. Good blood glucose control reduces the risk of congenital abnormalities, pregnancy loss, pregnancy-induced hypertension, preeclampsia, and perinatal mortality. National guidelines in the United Kingdom already recommend metformin for use in diabetes during pregnancy and gestational diabetes if a healthcare professional feels it is appropriate.
Following a European review of data from a non-interventional cohort study of population registries in Finland (the CLUE study), the product information for metformin is being updated to permit the use of metformin during pregnancy and the periconceptional phase as an addition or an alternative to insulin, if clinically needed. The Medicines for Women’s Health Expert Advisory Group of the Commission on Human Medicines has also reviewed the data from the study and agreed that the product information should be updated.
The study investigated immediate and longer-term effects of exposure to metformin in-utero on children born to patients with pre-existing type 2 diabetes, gestational diabetes, or polycystic ovary syndrome. The results of the study were reassuring, with no safety signals of concern identified for use of metformin in pregnancy relating either to those who were pregnant or their baby. Among secondary outcomes, similar rates of births that were small (low weight) for gestational age were observed with exposure to metformin and within the group of patients with untreated gestational diabetes. By contrast, an increased risk of small for gestational age was observed with exposure to metformin compared with insulin, which may relate to an overall increase in body weight due to use of insulin.
The advice in the Summary of Product Characteristics for metformin products is being updated. Corresponding changes are also being made to the Patient Information Leaflet. These changes have already been made to the brand-leader Glucophage. Some fixed-dose combination products containing metformin contain other active substances that should be avoided during pregnancy. The product information for fixed-dose combination products containing metformin will be reviewed and advice on use in pregnancy updated if appropriate.
This update to the product information reflects clinical practice and advice in current United Kingdom guidelines.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/metformin-in-pregnancy-study-shows-no-safety-concerns
In Hong Kong, there are 118 registered pharmaceutical products containing metformin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 19 cases of adverse drug reaction related to metformin, but these cases were not related to low birth weight. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Mar 16, 2022
Issued at HKT 15:00
|
| |
