Demand for Ozempic not slowing, pharmacists say

CTV National News: Ozempic lawsuit proposed A proposed class action lawsuit against Ozempic’s maker alleges rare, but serious side effects. Melanie Nagy reports.

Whether for weight loss or diabetes management, Canadian pharmacists say demand for Ozempic prescriptions does not appear to be slowing, despite a proposed lawsuit over alleged side effects.

The lawsuit, filed with the Supreme Court of British Columbia in October, claims the makers of Ozempic—a drug created to manage Type 2 diabetes, but which has gained massive popularity as a weight loss tool—failed to adequately describe the potential side effects. Those side effects, the document states, include intense vomiting, painful gallstones and masses of food slowly forming a painful obstruction in the stomach as the result of a condition called gastroparesis.

The proposed class-action lawsuit has not yet been authorized by a judge, and its claims haven’t been tested in court.

Regardless of the concerns raised by the lawsuit, pharmacists representing national and provincial associations say demand for the drug is as high as ever – high enough to fuel ongoing supply issues.

Moreover, they say they're not surprised to see the symptoms listed in the lawsuit.

"I haven't heard that people aren't prescribing it because of the adverse effects," Dr. Barry Power, chief pharmacist officer at the Canadian Pharmacists Association, told CTVNews.ca in a phone interview. "It's very common for adverse effects to become known after a drug is on the market, especially if it's in very widespread use, as Ozempic is, so when I saw the reports, I wasn't particularly shocked."

Jen Belcher, pharmacist and vice president of strategic initiatives for the Ontario Pharmacists Association, agrees.

"I'm not surprised by any of the side effects that are listed in this case, because they are known side effects of the drug," she said. "It would just be up to the court to decide whether or not things like the monograph do an adequate job of conveying the risk so that health-care providers can have those conversations with patients."

Health Canada approved Ozempic as a prescription medication for adult patients with Type 2 diabetes mellitus in 2018. The active ingredient, semaglutide, mimics the effects of a hormone called GLP-1 that is naturally produced in the intestines and works with the pancreas to release insulin and balance blood glucose levels. It also reduces appetite and food cravings by slowing digestion and sending signals to the brain that indicate the body is full or satiated.

While it hasn't been specifically approved for weight management in Canada, prescribers can, and commonly do, prescribe it off-label for that use in lieu of its sister drug, Wegovy. Wegovy is also produced by Ozempic manufacturer Novo Nordisk and has been approved as a weight loss medication in Canada, but has yet to reach shelves here.

According to Power, an estimated 25 to 50 per cent of Ozempic prescriptions in Canada are for weight management.

Both drugs use the same active ingredient and both are administered through a weekly subcutaneous injection, but the dose prescribed for weight loss is higher than for diabetes management, and Wegovy comes with an injector specifically calibrated for that higher dosage, explained Belcher.

Whether it's being prescribed for diabetes or off-label for weight management, Belcher said prescribers have access to information about Ozempic's rarer, more serious side effects. These include some of the complications cited in the proposed class-action lawsuit as well as other risks for people with certain family medical histories and underlying disorders, such the risk of developing thyroid c-cell tumours or pancreatitis.

"A lot of that information is important to consider in the assessment and prescribing process for people who are considering using this type of medication or any other medication for diabetes or other endocrine disorders," Belcher said.

When a relatively new drug is prescribed as widely as Ozempic has been, both Belcher and Power said it's not uncommon to see some rarer side effects emerge. What remains to be seen is if the serious side effects associated with Ozempic become common enough, or if serious new risks emerge that are sufficient to compel Health Canada to withdraw the drug's approval order changes to its monograph. According to Health Canada, a product monograph is a factual, scientific document on a drug that describes the properties, claims, indications and conditions of usefor that drug, as well as other information necessary for safe and effective use of the drug.

"It's fairly rare that the approval would be pulled for a drug," Power said. "What is more likely to happen first is that there would be a warning of some type issued. Changes to the product monograph may include, in some cases, a boxed warning, which is a more serious concern."

A boxed warning, also known as a "black box warning" or a "serious warnings and precautions box" is a special warning on a prescription drug's label that lists any significantly dangerous or potentially life threating risks associated with that drug. Ozempic already contains a boxed warning about the risk of thyroid c-cell tumours.

While some health-care providers might choose not to prescribe the drug to certain patients out of an abundance of caution, it remains a popular choice among prescribers treating patients for diabetes and obesity.

For overweight patients for whom the benefits outweigh the risks, Belcher said the drug can mean the difference between qualifying or not qualifying for a knee surgery, or a hip replacement surgery.

"I've been able to take people off their narcotics because their back doesn't hurt as much because they're not carrying as much weight around," she added.

The drug remains so popular worldwide that a shortage that began in August and was projected to end in October is now expected to last until March, both Belcher and Power confirmed.

In response, pharmacists like Belcher have had to ration their inventory by dispensing no more than a month's supply of the medication at a time for most patients. In other cases, doctors, nurses and pharmacists have temporarily resorted to prescribing similar, more well-stocked medications instead.

"If we continue to see the real uptick in prescribing the way that we've seen over the last sort of 12 to 18 months with the benefits of the drug and the overall awareness of the weight loss component to it, we may be in a more acute shortage situation," Belcher said.