其 他 安 全 警 示
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| The United Kingdom: Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy is prolonged or repeated, consider monitoring of neonates for abnormal calcium and magnesium levels and skeletal adverse effects.
National review of risk in prolonged use:
The MHRA is not aware of any reports in the UK of skeletal adverse effects or relevant biochemical effects in the neonate following use of magnesium sulfate for foetal neuroprotection. However, following efforts to achieve increased uptake in preterm labour and birth (including through the PReCePT project), data suggests usage is increasing in the UK. Healthcare professionals should therefore be vigilant for any adverse effects in the neonatal period if in-utero exposure to magnesium sulfate is prolonged.
The Commission on Human Medicines and its Expert Advisory Groups the Medicines for Women’s Health Expert Advisory Group and the Paediatric Medicines Expert Advisory Group considered data for the use of magnesium sulfate in the UK. Based on their recommendations, the product information for products containing magnesium sulfate will be updated to warn of skeletal adverse effects observed with administration for more than 5–7 days in pregnancy.
Healthcare professionals are advised of the followings:
• Maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy may be associated with adverse effects in the foetus, including hypocalcaemia, skeletal demineralisation, osteopenia, and other skeletal adverse effects
• If prolonged or repeated use of magnesium sulfate occurs during pregnancy (for example, multiple courses or use for more than 24 hours), consider monitoring of neonates for abnormal calcium and magnesium levels and skeletal adverse effects
• Report suspected adverse drug reactions to magnesium sulfate following exposure during pregnancy on a Yellow Card
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/magnesium-sulfate-risk-of-skeletal-adverse-effects-in-the-neonate-following-prolonged-or-repeated-use-in-pregnancy
In Hong Kong, there are three registered injectable pharmaceutical products containing magnesium sulfate, which are indicated for the treatment and prevention of hypomagnesaemia, pre-eclampsia and eclampsia and are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse reaction report related to the drug.
Related news regarding recommendation against prolonged use of magnesium sulfate in pregnancy was previously released by the US Food and Drug Administration (FDA) and was posted on the Drug Office website on 31 May 2013. Letters to inform healthcare professionals for the warnings were also issued on the same day. The matter has been discussed in the meeting of the Registration Committee (the Committee) of the Pharmacy and Poisons Board on 3 December 2014. The Committee decided that the product inserts of injectable pharmaceutical products containing magnesium sulfate should be updated to include the relevant safety information. The package inserts for all the above three registered injectable pharmaceutical products containing magnesium sulfate have been updated to include the above safety information endorsed by the Committee. The DH will remain vigilant on any further safety update of the drug issued by other overseas drug regulatory authorities.
Ends/ Saturday, May 18, 2019
Issued at HKT 17:00
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