Health Canada is independently reviewing a class of drugs used in diabetes and weight-loss medications following reports that they may lead to a risk of suicide.
In an email on Friday, the federal department told CBC News that it would be doing an assessment of Canadian and international data that looks at the risk of suicidal thoughts, self-harm and suicide when it comes to a class of drugs known as GLP-1 receptor agonists.
“Health Canada continues to monitor all side-effects of marketed health products … to help ensure that the benefits of the product continue to outweigh the risks,” the statement says.
The decision comes after the European Medicines Agency and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) said recently they were also reviewing the drugs because of reports that people’s mental health had been impacted.
“I think it is important that safety is first if there is any indication of any adverse effects that are concerning and are serious, that any health authority ought to look into it in a serious manner,” said Dr. Sean Wharton, an obesity doctor who has clinics in Ontario.
Some of Wharton’s clinical research is done in partnership with the companies whose medications will likely be under review by Health Canada.
What medications could be assessed in Canada?
GLP-1 receptor agonists, which were originally developed to treat Type 2 diabetes, have been used for more than 15 years.
In the last eight years, they’ve also been used to treat obesity, as they mimic a gut hormone that suppresses appetite, promoting a feeling of fullness.
GLP-1 receptor agonists are a class of drugs used in popular medications such as Novo Nordisk’s Ozempic, which contains the active ingredient semaglutide and is approved to treat Type 2 diabetes.
The drug has also made headlines recently because it’s being used for weight loss.
While Health Canada didn’t specifically say which brand-name medications are included in its review, the following will likely be under consideration, along with Ozempic:
- Novo Nordisk’s Wegovy, which is approved in Canada for people with obesity but is not yet available to patients.
- AstraZeneca’s drug for Type 2 diabetes, exenatide, which is marketed as Bydureon.
- Eli Lilly’s dulaglutide, marketed as Trulicity.
- Sanofi’s lixisenatide.
- Sanofi’s Soliqua.
Drug company says safety top priority
Novo Nordisk said in an email to CBC News on Friday that patient safety is of “utmost importance.”
“We take all reports about adverse events from use of our medicines very seriously,” its statement says.
“Our team is continuously monitoring the safety profile of our products and collaborating closely with health authorities to ensure patient safety information, including adequate information on side-effects, are included in the product monograph.”
The company said that current safety data hasn’t shown that GLP-1 receptor agonists semaglutide or liraglutide directly cause suicidal or self-harming thoughts.
Novo Nordisk said its products have been on the market for more than 10 years.
Dr. Nav Persaud, a family doctor at St. Michael’s Hospital in Toronto, said that even though these medications have been used for a while, concerns might be surfacing because more people are using them.
“These sorts of adverse events that are not necessarily caused by the medication are inevitable when a large number of people are exposed to a medication,” he said.
Complaints sparked drug reviews in other countries
Of the 688 adverse reaction reports listed on Health Canada’s website concerning Novo Nordisk’s Ozempic, CBC News counted three related to suicide and depression between 2018 and end of March 2023.
The vast majority were related to nausea, vomiting and stomach pains.
These adverse reaction reports are self-reported by patients and their health-care providers, so they don’t undergo review.
It’s unclear how many other adverse reaction reports there might be for the other approved medications with GLP-1 receptor agonists.
But Wharton said he thinks these negative mental health reports might be observations rather than actual side-effects.
It’s possible that the majority of people who look for weight-loss drugs also have higher levels of mental health disorders to begin with, he said.
“So the question is does it correlate to the medication [or] does it correlate to the patient population?” he said.
The MHRA in the U.K. said in news reports that its review was initiated on July 12. The agency said it could not specify when the review would conclude or what the results might be.
It said the review would consider safety data, including adverse drug reactions reported by patients and clinicians to the MHRA.
From 2020 to July 6 of this year, the agency received five reports of suspected adverse drug reactions involving semaglutide associated with “suicidal and self-injurious behaviour.” The reports came through its Yellow Card scheme for collecting and monitoring safety concerns such as side-effects from medicines.
From 2010 to July 6 this year, the MHRA received 12 suspected adverse drug reactions involving liraglutide also associated with “suicidal and self-injurious behaviour.”
The existence of a report is not proof of causation, the MHRA says.
The European Medicines Agency said earlier this month that it had begun investigating GLP-1 drugs after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm.
It is also investigating GLP-1 drugs for possible risk of thyroid cancer.
What happens if Health Canada finds safety risks?
Health Canada said that if it identifies new safety risks from its assessment, it will take “appropriate action,” including making these risks well known to Canadians and health-care professionals or changing the recommended use of the product.
Persaud said it’s unlikely that Health Canada will withdraw the medication following its review.
He said the most “consequential” regulatory change might be that the department adds a warning on the product monograph.
“This doesn’t seem like a situation where they’re highly concerned,” Persaud said.
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