Proposed class action lawsuit alleges Ozempic maker failed to disclose serious side effects

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

Intense vomiting. Painful gallstones. Masses of food slowly forming a painful obstruction in the stomach.

These are some of the side effects described by the members of a proposed class action lawsuit, which alleges that 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.

One B.C. woman says that the waves of gastrointestinal illness she suffered while on the drug could be “debilitating” at times.

“If the drug company isn't letting the doctors or the patients know that there's a risk to severe side effects like this, how on earth can we make an informed decision about a medication that we're going to put in our body?” Tracy Nygaard told CTVNews.ca.

The lawsuit was filed in October with the Supreme Court of British Columbia. It has not yet been authorized by a judge, and its claims haven’t been tested in court.

In a statement, Novo Nordisk, the manufacturer of Ozempic and other similar drugs named in the proposed class action, told CTVNews.ca: "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, is included in the product labelling."

Novo Nordisk added GLP-1 has been used to treat type 2 diabetes for more than 15 years, and for treatment of obesity for eight years.

"Novo Nordisk GLP-1 products such as semaglutide and liraglutide that have been authorized for use for more than 10 years. Semaglutide has been extensively examined in robust clinical development programs, large real world evidence studies and has cumulatively over 9.5 million patient years of exposure," the company said.

“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when used by appropriate patients consistent with the product labelling and approved indications.”

The proposed class action, filed by Ontario law firm Siskinds, applies to damages arising from the drugs Ozempic, Rybelsus and Wegovy, which are all semaglutide prescription drugs manufactured by Novo Nordisk.

Semaglutide is the active ingredient in this medication and it allows the drug to mimic a naturally occurring hormone to stimulate a decrease in blood sugar levels, along with stimulating insulin production. These hormones also inhibit appetite, making weight loss a common side effect.

It is this side effect that caused Ozempic’s popularity to skyrocket in recent years.

In 2022, more than 3.5 million prescriptions for Ozempic, worth nearly $1.2 billion, were dispensed by retail drugstores in Canada, according to the lawsuit.

Of the three drugs, only Wegovy is cleared by Canadian regulators to be used for weight loss, but Ozempic has been frequently prescribed for “off-label” use to help patients lose weight.

But while some have hailed Ozempic and similar drugs as the holy grail of both weight loss and diabetes management, research has begun to suggest that semaglutide drugs could hold more risk than previously known.

One University of British Columbia study published earlier last month examined health insurance claim records and found that semaglutide and liraglutide drugs were associated with a nine times higher risk of pancreatitis, as well as more than four time the risk of bowel obstruction.

A recurring theme among the Canadians that Siskinds has heard from since filing the proposed class action lawsuit is cases of gastroparesis or “paralyzed stomach”, Jill McCartney, a lawyer with the firm, told CTVNews.ca.

“It really puts people in a position where their stomach’s incapable of performing the mechanism of action that allows them to properly digest food. So it's quite debilitating and an issue that really impacts a lot of your daily life,” she explained.

“Other people that we hear from have had very serious gallbladder disease issues, and those can progress as far so people have to have surgery to have their gallbladder out.”

Siskinds lawyer Jordyn Liebman added that “there have been some instances of intestinal blockages that have been seen, and resultantly with that there have been some case reports of pulmonary aspiration, during different procedures, as well.”

The toll is one that has weighed on Nygaard, who said that at times she was so ill from side effects that she had to miss important events for her children. Nygaard has five of her own children along with two foster children.

“That’s not me, I am a mom that is involved,” she said. “I'm serious about my health and wanting, you know, to make sure that I'm looking after me, because if I don't look after me, I can't look after them.”

FROM ‘MIRACLE DRUG’ TO ‘DEBILITATING’

In 2018, Nygaard was trying to find a new medication that might work to help manage her diabetes, wary after her body wasn’t able to comfortably tolerate metformin, a common medication for type 2 diabetes.

A nurse practitioner suggested something Nygaard had never heard of: Ozempic, a prescription drug that had been cleared by Canadian regulators just that year.

“I took it to my doctor, I asked him, you know, would this be a good one for me to be on?” Nygaard said. “What are the side effects? Any complications with this drug? I had had a hard time with metformin. It made my stomach very sick. So I was scared to try anything new.”

She says her doctor told her, “it looks like the side effects are minimal and temporary. Yeah, this would be a good drug for you. It's supposed to be quite the miracle drug actually.”

Nygaard said she experienced serious gastrointestinal side effects the next day that made her unable to leave the bathroom for hours. But the symptoms cleared up shortly and the next couple of months went smoothly.

“I thought okay, cool. We just found something that works, is controlling my blood sugar, it's doing really well, and then bam, was I ever sick (again),” she said. “Two days of gastrointestinal illness where I couldn't leave the house. My husband was so worried he took a day off work and stayed home to care for me because I couldn't care for anyone.”

The pattern kept continuing. Nygaard said she would be fine for a few months, and then be struck, seemingly out of the blue, with intense gastrointestinal symptoms.

Some doctors told her that it was simply a side effect of being diabetic, Nygaard explained, and others told her explicitly to keep taking Ozempic, even when she began suspecting that the drug could be behind her symptoms.

“I'm like, ‘but I feel like it might be the drug causing this.’ And they're like, ‘no, no, no, no, the side effects listed are not serious and they're temporary’,” she said. “’Don't go off it, or you're going to do more damage to yourself.’ I listened to them, kept trying and trying and kept having these incidences where I would be so very sick.”

One night in 2021, she ended up being rushed to the hospital in an ambulance, “shaking and clammy, sweaty and throwing up.”

In the wake of this scare, doctors ordered a scope procedure to try and find the source of her illness. Everything looked fine, they told her—except for one bizarre detail.

Nygaard said doctors had found undigested food in her stomach, even though she had fasted ahead of the scope, per the doctor’s orders.

“I said, well, is that because I'm on Ozempic?’” Nygaard said, recounting the conversation. “He said ‘yes, it is likely because you are on Ozempic.’ I said, ‘So am I having a different kind of reaction than is what is expected?’ And he said, ‘I don't know enough about it’.”

Part of how Ozempic works is to slow digestion down, limiting the amount of sugar the body has to process by only allowing a certain amount of food to go through at a time.

Around the time of this exam, Nygaard stopped taking Ozempic, as it was the only medication she was on at the time.

“And all of my symptoms stopped,” she said.

SIDE EFFECTS NOT WARNED OF ACCURATELY, LAWSUIT ALLEGES

Nygaard said that multiple doctors emphasized to her that Ozempic’s side effects were just temporary. But she’s “very concerned” that she may have permanent damage as a result of taking the drug.

“I'm worried now that I am at the beginning of gastroparesis, because I can't tolerate a lot of food anymore,” she said.

Others are alleging permanent damage as part of the proposed class action lawsuit, McCartney said.

“We can get people that have permanent injury, where they might have permanent stomach paralysis or permanent removal of their gallbladder,” McCartney said, adding that others have had “more transient experiences” with their adverse reactions.

The connecting thread is that patients said they weren’t aware there was a chance that side effects this severe could happen.

“It wasn't communicated to them or they didn't appreciate that they could have the level of gastrointestinal or gallbladder disease issues that they've experienced,” McCartney said. “They didn't understand that it was a risk that they could have permanent injury following taking the drug.”

A product monograph for consumers available on Novo Nordisk’s website lists three side effects as “very common,” meaning that they may affect more than one in 10 people: nausea, diarrhea and low blood sugar. The monograph notes for the first two symptoms that they “usually (go) away over time”.

Under “common” side effects, defined as affecting up to one in 10 people, the monograph mentions indigestion, vomiting, inflamed stomach, heartburn, stomach pain, bloating, constipation, gallstones, feeling dizzy and tired, gas, less appetite and weight loss.

The lawsuit alleges that the monographs are insufficient because they do not provide adequate warning of the risk of injury, including no mention of cholecystitis (gallbladder inflammation), gastroparesis and malnutrition, among others.

“For any type of drug that's on the market, of course there's a risk benefit profile,” McCartney said. “I think the heart of this case is certainly more about appropriate and adequate consent communication to health care providers and patients.”

Although the case is relatively new, McCartney said the firm has heard both from patients who were using it for weight loss and from those who were prescribed the drug for its intended purpose of managing diabetes.

The lawsuit is seeking, among other things, special damages in the amount of $500,000 for each person affected by the drugs in question.

Weight loss may be an “off-label” use of Ozempic, but if the class action lawsuit proceeds it would cover Canadians who were prescribed Ozempic for any reason, McCartney said.

“I wouldn't be surprised to hear from hundreds of people in relation to this case. It certainly is a widely prescribed drug,” McCartney said.

THE TOLL OF DIABETES

Nygaard says her experience with Ozempic is also a serious setback in her quest to find a way to manage her diabetes.

Those with Type 2 diabetes are unable to properly regulate how the body uses sugar, due to the two-fold problem of the pancreas not creating enough insulin, and cells responding poorly to the insulin that is present.

This chronic condition can be managed through diet and exercise, but often that isn’t enough to keep blood sugar levels at a healthy level. High blood sugar can affect numerous organs in the body, and type 2 diabetes going untreated can lead to kidney damage, an increased risk for heart disease or stroke, and even eye damage that can result in blindness.

According to Health Canada, more than 60 per cent of people with Type 2 diabetes develop some form of vision damage. Over three million people in Canada have diagnosed diabetes, and 90 per cent of these cases are type 2 diabetes.

A study published this summer suggested that cases of diabetes globally will jump from 529 million to 1.3 billion by 2050 due to a lack of effective strategies to fully combat the disease.

Although there are multiple medications or methods to handle diabetes, many patients struggle to find the right one or the right combination.

“My mother is able to take metformin and handle it,” Nygaard said. “I was hoping with Ozempic, as it was deemed this miracle drug, that it would be the solution, it would be something that wouldn't make me sick.

“It caused a lot of stress, knowing that my blood sugar is creeping up, and there's no solution.”

If she had received proper warnings about the scope of the side effects of Ozempic ahead of time, she said she may have still tried Ozempic, but would’ve been able to be confident in stopping earlier when she realized she was experiencing severe side effects.

“I feel like we were not informed of any serious implications,” she said.

She added that it has been hugely validating to learn that others share her experience.

“Now more people are coming forward and they're saying, ‘yeah, the gastrointestinal things are horrible.’”

A diabetes specialist told her at one point that she was “whining,” she said, and that Ozempic was “a wonder drug.”

“I don't want to see anybody else suffer on this drug needlessly, and being told, ‘Oh, no, it's fine. The side effects are minor, and they're temporary.’ No, they're not for everyone,” Nygaard said. “Maybe they are for some people. That's wonderful. If it works for them, that's great. But for some people, it isn't. And they need to be believed.”

Those who are looking for more information on the class action lawsuit can do so online.