Health Canada approves updates to Mifegymiso prescribing information: Ultrasound no longer mandatory

Contact: BMORS Enquiries

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.

As outlined in the product monograph, Mifegymiso should not be prescribed to patients who are more than nine weeks (63 days) pregnant or have an ectopic pregnancy. Under these conditions, the drug may not successfully terminate the pregnancy, may damage the fetus, and can result in serious health risks to the pregnant woman. The use of Mifegymiso could mask a ruptured ectopic pregnancy as the symptoms associated with both may be similar.

As part of the update, the product monograph now includes the patient information card, which outlines important information for the patient such as where to go for emergency assistance. All other Mifegymiso prescribing information remains the same (see links below for previous changes communicated in November 2017). The latest version of the Mifegymiso product monograph is available on Health Canada’s website.

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.

Health Canada continues to monitor the safety of Mifegymiso through its post-market surveillance program to help ensure that the benefits of the product continue to outweigh the risks.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For more information

• Canadian product monograph for Mifegymiso
• November 17, 2017, Dear Healthcare Professional Letter: MIFEGYMISO (mifepristone and misoprostol tablets) - Updates to Product Monograph and Risk Management Plan
• November 17, 2017, Information for consumers: Health Canada updates prescribing and dispensing information for Mifegymiso
• May 17, 2017, Dear Healthcare Professional Letter: MIFEGYMISO (mifepristone and misoprostol tablets) - Canadian Distribution and Administration Program

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