Other safety alerts
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| The United Kingdom: Misoprostol vaginal delivery system (Mysodelle): reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Mysodelle can cause uterine tachysystole that may not respond to tocolytic treatment.
A routine EU review of Mysodelle investigated reports from a study in which 13% of women (90 of 678 patients) randomly assigned to the 200mcg misoprostol vaginal insert developed uterine tachysystole requiring intervention. In 5 cases (0.7% of women), uterine tachysystole did not subside with the use of tocolysis. Uterine tachysystole has been associated with poor uterine placental perfusion leading to a decrease in foetal oxygenation and eventually foetal compromise. In the study, despite the higher incidence of tachysystole requiring intervention recorded in women given the misoprostol vaginal insert than those given a dinoprostone vaginal insert (13% versus 4%, respectively), neonatal outcomes did not appear to differ.
The EU routine review of these cases concluded that uterine tachysystole that may not respond to tocolytic treatment can be caused by Mysodelle, even when used in accordance with the product information. The product information for Mysodelle has been updated to reflect this finding, and with actions to take to ensure that this risk is adequately managed.
Healthcare professionals are advised to:
- monitor patients closely and remove the vaginal delivery system immediately if any of the following apply: tachysystole: more than 5 contractions in a 10-minute window, averaged over a 30-minute window; prolonged contractions: single contractions lasting 2 minutes or longer; hypertonic contractions: contractions that are too frequent and a high resting tone in the uterus
- also remove the vaginal delivery system in the following instances: there is a clinical concern for the mother or baby; onset of labour: rhythmic, firm contractions of adequate quality associated with cervical change, and/or at the latest when cervical dilation is 4 cm; when 24 hours have elapsed since insertion
- be prepared to administer tocolytic therapy; should this be needed, it can be administered immediately after removal of Mysodelle
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/misoprostol-vaginal-delivery-system-mysodelle-reports-of-excessive-uterine-contractions-tachysystole-unresponsive-to-tocolytic-treatment
In Hong Kong, Misodel Vaginal Delivery System 200mcg (HK-64060) is a vaginal delivery system containing misoprostol. It is a pharmaceutical product registered by Ferring Pharmaceuticals Ltd, and is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to misoprostol. In light of the above MHRA’s announcement, letters to inform local healthcare professionals of the above safety information will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Feb 7, 2018
Issued at HKT 16:00
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