Other safety alerts
|
| |
| Canada: Health Canada approves updates to Mifegymiso prescribing information: Ultrasound no longer mandatory |
| |
Health Canada is informing Canadians that the prescribing and patient information for Mifegymiso has been updated to reflect that an ultrasound is no longer required before the drug is prescribed. Mifegymiso is a combination product containing two drugs (mifepristone and misoprostol) that are taken in sequence for the medical termination of a pregnancy.
Previously, the Canadian product monograph for Mifegymiso indicated that an ultrasound was required before prescribing Mifegymiso to confirm the gestational age (number of weeks pregnant) and to rule out an ectopic pregnancy (a pregnancy outside the womb).
With the changes to the product monograph, prescribers now have the flexibility to use their medical judgement on how best to determine the gestational age and to rule out an ectopic pregnancy. It also responds to concerns that some patients may have been facing unnecessary barriers or delays in accessing this product. The product monograph still recommends an ultrasound when the gestational age is uncertain or an ectopic pregnancy is suspected.
Health Canada based its decision on a review of the information submitted by the company (Linepharma International Limited, which is represented in Canada by Celopharma Inc.), the most recent scientific literature, and experience with the use of the product internationally.
Health Canada has asked the company to monitor the risks related to potential inaccurate pregnancy dating and missed ectopic pregnancy diagnoses, and to notify Health Canada should these safety concerns arise. Health Canada will act quickly to take appropriate action should safety concerns emerge.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69620a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Apr 17, 2019
Issued at HKT 16:00
|
| |
