The regulatory update opens the door for prescribers to use their medical judgment
Health Canada has announced an update to the prescribing and patient information for a contraceptive drug treatment that eliminates the need for an ultrasound before it is prescribed.
The treatment, called Mifegymiso, is a combination product consisting of two drugs that are taken in sequence to terminate a pregnancy. When it was initially brought to market, its accompanying product monograph indicated that those who wish to take it must first undergo an ultrasound, which would confirm the gestational age (number of weeks pregnant) as well as 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,” the regulator said. “It also responds to concerns that some patients may have been facing unnecessary barriers or delays in accessing this product.”
Last year, investigative reports revealed that women in Nova Scotia who wanted to use Mifegymiso faced extended delays in treatment because the only abortion clinic in the province is not allowed to perform ultrasounds to determine the progress of a pregnancy. In one reported case, the woman was advised she would have to wait about two weeks; the treatment can only be used within the first nine weeks of pregnancy.
While ultrasounds are no longer required, the product monograph still recommends an ultrasounds in instances where 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 [manufacturing] company, the most recent scientific literature, and experience with the use of the product internationally,” the regulator said.
It went on to emphasize that Mifegymiso should not be prescribed to patients who are more than 63 days pregnant or have an ectopic pregnancy, as the drug may not work, may damage the fetus, and create serious health risks for the pregnant woman.
“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,” it said.
The regulator added that it will quickly take appropriate action in case safety concerns emerge, and it will continue to monitor Mifegymiso’s safety through its post-market surveillance program.
