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Saturday, October 19, 2024

More Serious Side Effects from Ozempic and Wegovy Weight Loss Drugs

 

More Serious Side Effects from Ozempic and Wegovy Weight Loss Drugs

Another woman is suing Ozempic and Wegovy drugmaker Novo Nordisk, claiming that their popular GLP-1 (semaglutide) weight loss drugs led to a near-fatal emergency surgery and a lifelong ileostomy bag attached to her abdomen. Juanita Gantt was prescribed Ozempic and Wegovy by her doctor due to her increased diabetes risk, as she weighed 242 pounds despite numerous attempts to lose weight. Several months later, her husband found her unconscious on the floor. During emergency surgery, doctors discovered that part of her intestine had died and needed to be removed. Later, while recovering, Gantt went into cardiac arrest, and the hospital warned her daughter that she might not survive.1

The lawsuit, the latest in a growing wave of lawsuits against the pharmaceutical giant, emphasizes the risks of failure to provide adequate informed consent, claiming that the labels for the popular weight loss drugs do not sufficiently warn patients and doctors about potential side effects, such as gastroparesis (stomach paralysis) and bowel obstruction—both of which are serious, potentially life-threatening conditions.1

“I Had No Warning” Plaintiff Says of Ozempic Drug Risks That Almost Cost Her Life

While GLP-1 drugs are praised by a number of doctors improving health outcomes, particularly for

obese and diabetic patients, some patients are grappling with severe health complications from side effects they say they were never warned about. Gantt’s lawyer argues that the manufacturer should have devoted more resources to ensuring informed consent, which is essential to patient-centered care and safety.1

“It’s put a lot of resources into marketing the drug, hundreds of millions of dollars to expand the market [and] get new patients for the drug, but it hasn’t spent that money on warning patients of the risk of gastroparesis, ileus, small bowel obstruction, and the fact that these injuries can be severe, even if it’s in a rare case,” Gantt’s attorney, Parvin Aminolroaya, said in a prepared statement.1

Drugmakers Spent Over $1B on Advertising in 2023

In 2023, Novo Nordisk and other drug makers collectively spent over $1 billion on ads for their weight loss and diabetes drugs, a stark 51% increase from the previous year. The surge reflects an aggressive push to capture new customers, particularly for their high-demand semaglutide drugs despite their high costs and limited insurance coverage. However, this level of advertising  spending raises ethical concerns about deceptive marketing that minimizes the risks and full context of the medications being promoted.2

In response to Gantt lawsuit and a growing number of similar lawsuits, Novo Nordisk told CBS News that “the known risks and benefits of semaglutide and liraglutide medicines are described in their FDA-approved product labeling.” The company also said that “the allegations in the lawsuits are without merit” and that it intends to “vigorously defend against these claims.” Novo Nordisk added that semaglutide, sold under the Ozempic and Wegovy brand names, has been thoroughly studied in extensive clinical development programs and large real-world evidence studies.1

Pfizer’s $2.3 Billion Fine is a Warning About Off-Label Promotion

The troubled history of most pharmaceutical companies and their past lawsuits and settlements shows that despite FDA licensure—as Novo Nordisk references in their statement—unintended consequences from undisclosed side effects have often surfaced after licensure. In many cases, this has led to drugs being pulled from the market, sometimes decades after their approval and widespread use. By then, the damage is already done.

People have suffered serious harm, and some have lost their lives due to products that initially met all regulatory requirements and were approved by agencies tasked with ensuring consumer safety. In 2009, Pfizer paid $2.3 billion—the largest criminal fine in U.S. history—for illegally promoting drugs like Bextra for unapproved uses, highlighting the dangers of off-label marketing despite regulatory oversight.3

Serious Side Effects Often Only Recognized After FDA Licensure and Widespread Use

As GLP-1 medications like Ozempic and Wegovy have become widely used to treat diabetes and obesity before serious, previously unrecognized side effects have emerged, which have required updates on drug labels. Initially, common side effects such as nausea and vomiting were acknowledged, but over time more severe complications like gastroparesis (stomach paralysis), bowel obstruction, ileus, pancreatitis, and gallbladder issues were added. Patients have also reported risks of acute kidney injury, cardiac arrhythmias, thyroid tumors, and suicidal thoughts, raising even more safety concerns. Some of these side effects, like delayed gastric emptying and severe allergic reactions, were not identified or recognized until the weight loss drugs were widely used.4

“It’s actually not unusual for rare new side effects to emerge, or drugs to get slapped with new safety warnings years after they’re first approved. “It is more common than you think,” says Mahyar Etminan, a drug safety expert at the University of British Columbia in Vancouver. 5

New Study Links GLP-1 Drugs to Bone Loss

A recent study published in JAMA Network Open linked GLP-1 drugs to bone loss, building on a growing body of evidence that continues to uncover previously unrecognized side effects of these medications. In the study, researchers tracked 195 adults with obesity for a year following an initial low-calorie diet. Participants were divided into four groups: one received a placebo, another exercised while taking a placebo, a third group took a GLP-1 receptor agonist like Ozempic, and the final group took the GLP-1 drug and exercised.

The study found that those who took the GLP-1 receptor agonist without exercising experienced reduced bone mineral density in the hip and spine compared to those who exercised or took a placebo. The findings suggest that while GLP-1 drugs may aid in weight loss, exercising while taking the drugs is essential to preventing bone density loss.6

More Than 900 Semaglutide Lawsuits Filed While Profits Rise

As of September 2024, over 900 lawsuits filed have been filed against Novo Nordisk related to their semaglutide drugs, such as Ozempic and Wegovy, focusing on severe gastrointestinal complications like those that almost killed Gantt. These cases have been consolidated into a multidistrict litigation (MDL) in the Eastern District of Pennsylvania, with more cases expected to be added as additional patients continue to report unexpected complications. The number of lawsuits could grow significantly, potentially reaching thousands, as investigations into other more recently discovered side effects like vision loss and gallbladder issues continue to emerge​.7 8

While estimates may vary, the global market for GLP-1 analogues, such as Ozempic and Wegovy, is projected to generate $47.4 billion in revenue in 2024. By 2032, this figure is expected to rise dramatically to $471.1 billion, driven by increasing demand and widespread use of these weight loss drugs, despite continuing reports of severe side effects.9

To date, no updated regulations or widespread public education campaigns have been implemented by the government or semaglutide manufacturers to promote informed consent beyond the standard drug labels, which doctors do not always highlight and patients often overlook. Doctors and patients share the responsibility for ensuring there is full understanding of pharmaceutical product risks. However, the majority of the responsibility for awareness about the serious side effects of drugs continues to lie with the patient being encouraged to take the risk.


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