Ozempic (semaglutide) is a prescription drug approved to treat type 2 diabetes that has become one of the most in-demand medications in North America in recent years.
Demand for Ozempic, which is manufactured by Novo Nordisk, has driven shortages in the United States. Health Canada observed a significant surge in demand for the drug in 2023, prompting the publication of a supply notice about Ozempic that aimed to address concerns about potential scarcity of Ozempic in Canada and ensure an adequate supply for those prescribed the drug. Despite the notice, Health Canada announced in August 2023 that "intermittent shortages" were expected to occur from late August until early October 2023.1
"Miracle weight loss drug" trending on TikTok, #Ozempic
Canadian public health officials have acknowledged that demand for Ozempic is driven by its widespread use as a weight loss treatment.2 The drug's ability to suppress appetite and induce weight loss has been extensively promoted by celebrities and influencers on social media, with #Ozempic reaching over 850 million views on TikTok by April 2023.3
However, taking Ozempic for weight loss is an off-label use of the drug in Canada, as weight loss is not an indication for Ozempic that has been approved by Health Canada. Consequently, there are increasing concerns from diabetes specialists and public health academics about the drug being used inappropriately4 and users being put at risk of dangerous side effects from a drug that was not designed for their use.5
What is an off-label use? Why is it potentially dangerous?
When a drug is prescribed for an unapproved purpose or to a member of an excluded population, this is referred to as an "off-label" use.
Off-label drug use is inherently risky since the pharmaceutical product has not been proven safe or effective through Health Canada's strict regulatory process.
When a prescription drug is approved by Health Canada, it is approved for particular purposes. Health Canada's approval also stipulates the population for whom the drug can be prescribed, and certain sub-groups of the population are often omitted from the approval process, including seniors, because these populations are frequently excluded from clinical trials.
For a drug manufacturer to obtain approval for an additional indication or population, they must file a supplemental new drug submission (SNDS). Completion and approval of an SNDS for a new indication may be a long and expensive process for drug manufacturers, and they have little or no incentive to incur these costs if there will be no increase in sales.
Regulations governing the promotion of off-label drug use in Canada
There is no disputing that the manufacturer of a drug is barred from promoting off-label use.6Specifically, drug manufacturers are prohibited under the Food and Drug Regulations from promoting non-indicated uses and may be found civilly liable in Canada for wrongfully and falsely promoting any off-label use.
However, there is a common practice in the pharmaceutical industry of "reminder" advertising, where companies promote a drug without describing its indications and simply encourage people to "ask their doctor" about whether the drug might be right for them.
Ozempic is heavily advertised through "reminder" commercials. These advertisements may encourage off-label prescriptions, as research shows that when individuals request drugs by name, they are significantly more likely to have them prescribed.7
What are the potential risk and side effects from using Ozempic for weight loss?
Canadians who use Ozempic off-label for weight loss may be exposing themselves to several common and additional serious side effects.
Health Canada alerts consumers that common side effects in Ozempic users include may include nausea, vomiting, diarrhea, stomach pain and constipation. Ozempic may also lead to a number of serious side effects, such as:
- changes in vision,
- pancreatitis,
- severely low blood sugar levels when used with diabetes treatments,
- kidney problems, such as kidney failure,
- gallbladder problems
- severe allergic reactions, and
- thyroid tumours, including cancer, in rare cases.
Health Canada has also told reporters that it will be assessing data concerning risks of self-harm, suicidal thoughts, and suicide connected to GLP-1 receptor agonists, Ozempic's class of drugs.8
Ozempic may also be uniquely dangerous to particular groups of potential users. For example, the drug is contraindicated for people with a personal or family history of medullary thyroid cancer or who are pregnant or breastfeeding. The drug has also not been studied in people under age 18, and only limited studies have been performed in people aged 75 and older.
Even in the face of all these potential risks linked to the drug, Ozempic users may not be able to achieve prolonged weight loss from their use of the medication. A 2022 study found most people taking Ozempic off-label gained much of their weight back within a year of stopping use.9
Special thanks to Victoria Stephenson, Summer Law Student, who helped research this article.
Footnotes
3. https://www.cbc.ca/news/canada/british-columbia/b-c-ozempic-restriction-1.6815456
4. https://www.cbc.ca/news/canada/london/ozempic-off-label-1.6884141
5. https://www.cbc.ca/player/play/2231819843622
6. Goodridge v Pfizer Canada Inc., 2010 ONSC 1095 at para 15.
7. https://www.cbc.ca/player/play/2231819843622
8. https://www.cbc.ca/news/health/health-canada-review-diabetes-weight-loss-1.6921759
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
