Popular Weight Loss Drugs Taken by Millions Hold Highest Safety Warnings

Ozempic and Wegovy may help people lose weight but are associated with a long list of very serious side effects.

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Nearly half of Americans say they’re interested in using a safe and effective prescription drug to lose weight, as a relatively new class of drugs initially approved to treat diabetes is growing in popularity for their ability to shed pounds with minimal effort.

A new trend fueled by more than 4,000 ad campaigns on social media, celebrities, and news coverage is enticing millions of Americans to turn to Ozempic and Wegovy, despite the potential harms associated with the drugs.

Ozempic is a weekly injection first approved by the U.S. Food and Drug Administration (FDA) in 2017 to help lower blood sugar in adults with Type 2 diabetes by forcing the pancreas to produce more insulin.

However, researchers noticed during pre-approval studies that the drug had an unintended side-effect: Ozempic reduced a person’s appetite, which resulted in weight loss. This created a demand among patients without diabetes requesting the medication be prescribed off-label to help them lose weight.

The Skyrocketing Demand for Ozempic and Wegovy

According to a 2023 Tebra survey:

• 15 percent of Americans have personally taken Ozempic for weight loss.
• 42 percent of medical practitioners have had patients without diabetes ask for a prescription.
• 18 percent of medical practitioners have prescribed it for weight loss.
• 14 percent of medical practitioners have personally taken the drug for weight loss.

As demand has grown for Ozempic, the drug’s manufacturer Novo Nordisk, reportedly spent $11 million last year buying more than 457,000 meals to educate doctors and other prescribers about its popular weight loss drugs, according to a July 5 STAT news report, and developed another medication called “Wegovy.”

Mechanisms for Weight Loss and Side Effects

Ozempic and Wegovy contain the same active ingredient, semaglutide, although Wegovy contains a larger amount. Wegovy was approved in 2021 by the FDA as a treatment for obesity in individuals aged 12 or older and for adults who are overweight with a weight-related health condition. 

While Ozempic is available in 0.25 milligrams, 0.5 mg, 1.0 mg, and 2 mg doses, Wegovy is available in 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg single-use injections to be given on an escalated dosing schedule (pdf) over five months to minimize gastrointestinal adverse reactions. Wegovy is designed to be taken long term and may result in an individual gaining much of their weight back if they stop taking the medication. However, having only received recent approval, the long-term effects of taking Wegovy are unknown.

Ozempic and Wegovy are glucagon-like peptide-1 (GLP-1) receptor agonists that mimic the body’s natural GLP-1 hormone. GLP-1 is released from cells in the small intestine and in smaller quantities by the pancreas and central nervous system. GLP-1 helps regulate appetite, stimulates insulin secretion, inhibits glucagon secretion, and delays gastric emptying.

For weight loss, the semaglutide in Ozempic or Wegovy acts on GLP-1 receptors in the brain’s appetite center to reduce hunger and increase fullness, so people feel full with smaller meals and eat less. Studies show the drug works by decreasing food intake rather than increasing energy expenditure to burn calories.

A study published in 2022 in JAMA Network Open followed 175 patients taking semaglutide over six months. Results showed a reduction in total body weight of 5.9 percent at three months and 10.9 percent at six months.

Out of 175 patients, almost half (85 patients) reported adverse effects, including gastrointestinal symptoms, nausea, vomiting, diarrhea, and fatigue. Five patients had to stop taking the drug due to the intolerability of adverse effects, while 15 patients had to reduce or remain on the same dose to avoid exacerbation of adverse effects.

A 2022 study published in the New England Journal of Medicine found that overweight or obese participants who took 2.4 mg of semaglutide once weekly, in addition to lifestyle changes, experienced a sustained reduction in body weight.

In this double-blind trial, 1,961 adults with a body mass index of 30 or greater, who did not have diabetes, were enrolled in the study and randomly assigned, in a ratio of 2 to 1, for 68 weeks of treatment with a weekly 2.4 mg dose of subcutaneous semaglutide or placebo, plus lifestyle intervention.

The mean reduction in body weight from baseline to week 68 was 14.9 percent in the semaglutide group as compared with 2.4 percent in the placebo group.

Nausea and diarrhea were the most common adverse events reported with semaglutide, and more participants in the semaglutide group than in the placebo group discontinued treatment due to gastrointestinal events—59 participants compared to five in the placebo group.

In a separate 68-week medical study published by Novo Nordisk on Wegovy, all participants were given Wegovy but also instructed to reduce calories and increase physical activity throughout the study—which will also facilitate weight loss.

After 20 weeks, some people continued to take Wegovy, while others switched to a placebo. From weeks 20 to 68, those taking Wegovy continued to lose weight, while people taking a placebo regained much of the weight they had lost. The study results suggest that Wegovy may need to be taken long term and that the weight may return if people stop taking it.

Approximately 7 percent of study participants taking Wegovy (92 people) dropped out of the study due to side effects, compared to only 3.1 percent (20 people) in the placebo group.

Wegovy and Ozempic Carry FDA’s Highest Safety Warnings

Losing weight with drugs like Ozempic and Wegovy may come at a price due to the side effects as well as the potential unknown long-term adverse reactions. According to Wegovy’s website, both Wegovy and Ozempic have caused thyroid C-cell tumors, including thyroid cancer, in studies with rodents.

Whether the drugs can cause thyroid tumors or cancer in people is unknown because it has not been studied (pdf). Because of this, both Wegovy and Ozempic carry FDA box warnings—formerly known as “black box warnings”—the highest safety-related warnings the FDA can assign to medications.

In addition to potential thyroid tumors and cancer, these drugs are contraindicated for those with multiple endocrine neoplasia syndrome Type 2.

Other serious side effects include:

• Kidney failure.
• Inflammation of the pancreas.
• Hypoglycemia (low blood sugar).
• Gallbladder problems.
• Gastrointestinal disorders.
• Nervous system disorders.
• Vision changes.
• Persistent suicidal thoughts with increased severity with higher doses.

According to the package insert for Wegovy, treatment is associated with an increased risk of acute gallbladder disease, which was more prevalent in pediatric patients than adults. Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, was observed in patients treated with semaglutide and in patients treated with Wegovy during clinical trials.

Postmarketing reports indicate drugs containing semaglutide, such as Wegovy and Ozempic, may cause acute kidney injury and worsening chronic renal failure. Some cases have occurred in people who did not know they had underlying renal disease and experienced common symptoms like nausea, vomiting, or diarrhea.

In a trial of adult patients with Type 2 diabetes with a higher body mass index, diabetic retinopathy was reported in 4 percent of those who received Wegovy versus 2.7 percent in placebo-treated patients.

According to Novo Nordisk on their package insert, suicidal behavior and ideation, worsening depression, and unusual changes in mood and behavior have been reported in clinical trials with similar weight management products.

The European Medicines Agency announced in July that it was reviewing 150 reports of self-injury and suicidal thoughts from people who took GLP-1 receptor agonists, such as Ozempic and Wegovy. The UK’s Medicines and Healthcare products Regulatory Agency told Reuters in a statement on July 25 it was reviewing similar reports.

Wegovy’s insert carries a warning about suicidal thoughts because the FDA requires medications for weight management that affect the central nervous system to carry a warning, but the agency has not added the warning to Ozempic.

As of June 30, 2023, the FDA’s adverse event reporting system (FAERS) had received 160 reports of suicidal ideation, suicide attempts, depression, and suicidal depression associated with Ozempic and 24 cases attributed to Wegovy.

A total of 14,149 adverse events have been reported to the FDA since 2018 in those who have used Ozempic, including 6,253 serious cases and 163 deaths. A total of 2,201 adverse events, including 460 serious cases and six deaths, have been reported to FAERS attributed to Wegovy since the medication was authorized in 2021.