Table 1.

Prescribing advice for metformin in pregnancy. The primary independent resources for each country are shown in bold.

Country	Resource	Prescribing Advice for Metformin in Pregnancy
Australia	Australian Medicines Handbook	‘Usually replace with insulin; seek specialist advice. There is some clinical experience and metformin appears safe (however, long-term follow-up of children exposed in utero is not available).’
	TGA approved product information for DIAFORMIN, Alphapharm Pty Ltd.	‘When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels…’
Britain	British National Formulary	‘Can be used in pregnancy for both pre-existing and gestational diabetes.’
	MHRA approved product characteristics for DIAGEMET, Genus Pharmaceuticals Ltd.	‘When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels…’
New Zealand	New Zealand Formulary	‘During pregnancy, women with type 2 diabetes can be treated with metformin (unapproved indication), either alone or in combination with insulin.’
	MEDSAFE approved data sheet for METCHEK, PSM Healthcare Ltd.	‘Metformin should only be used in pregnancy if the potential benefits to the mother and fetus outweigh the risks of harm, taking into consideration the benefits and risks of other treatments such as insulin.’
United States	American Diabetes Association	‘Insulin is the preferred medication for treating hyperglycaemia… Metformin and glyburide may be used, but both cross the placenta to the fetus, with metformin likely crossing to a greater extent than glyburide. All oral agents lack long-term safety data.’
	FDA approved package insert for GLUCOPHAGE, Bristol-Myers Squibb	‘Because animal reproductive studies are not always predictive of human response, GLUCOPHAGE and GLUCOPHAGE XR should not be used during pregnancy unless clearly needed.’
Brazil	Resources as per the United States	Prescribing advice as per the resources used in the United States.
South Africa	South African Medicines Formulary	‘Category B. Relative contraindication. A number of trials have shown safety during pregnancy in either pre-existing or gestational diabetes, however insulin remains the treatment of choice.’
	Package insert for BIGSENS, Zydus Healthcare S.A. (Pty) Ltd.	‘The use of BIGSENS during pregnancy is not advised.’
Japan	Japan Diabetes Society Treatment Guide for Diabetes 2014-2015	‘When glycaemic control is poor, and diabetic complications are present, it is advisable to have an introduction to a facility that has a team of specialists in diabetes and pregnancy.’
	Package insert for Glucophage, Merk Sereno Co. Ltd.	‘During pregnancy, treatment of diabetes is based on insulin therapy. If you discover that you are pregnant while taking Glucophage, your treatment will be replaced by insulin.’
India	Endocrine Society of India	No published recommendations.
	Information for GET-MET, Ravenbhel Pharmaceuticals Ltd.	Contraindicated.