U.S. poison control centers are reporting a sharp increase in calls related to semaglutide, a drug used to treat Type 2 diabetes and obesity, CNN reported Wednesday.

Developed by drugmaker Novo Nordisk, semaglutide is sold under the brand names Ozempic for diabetes, and Wegovy for weight loss. According to Medscape, Novo Nordisk said the two drugs are not interchangeable — although Ozempic is often taken off-label for weight-loss.

According to CNN, America’s Poison Centers said that between January and November, it responded to nearly 3,000 calls  — a more than 15-fold increase since 2019 — about semaglutide. In 94% of those calls, semaglutide was the only substance reported, while 6% of the callers reported taking semaglutide plus one or more other drugs.

Also this week, an investigation by The BMJ highlighted examples of potentially illegal marketing of semaglutide in the U.K., suggesting the marketing may be a contributing factor to growing hype and ongoing shortages of the drug.

According to the BMJ report, webpages promoting semaglutide may violate U.K. laws, which prohibit the direct marketing of prescription drugs to consumers.

The New York Daily News reported that celebrities have publicly promoted Wegovy, helping to fuel the growing demand for the drug. According to Medscape, physicians looking to prescribe Ozempic are struggling to locate the medication for their patients due to shortages.

The hype — and the subsequent shortages — have arguably contributed to a growing  market for semaglutide knock-offs and an online black market for the drug, according to the BBC.

Meanwhile, the high cost of Ozempic — partially fueled by growing demand for Wegovy — has resulted in an increasing reluctance of insurers and employers to cover the drug. Reuters reported a growing number of employers are instead hiring virtual healthcare providers to implement weight-loss management programs for employees.

Aside from the drugs’ high cost and the reluctance of insurers to pay for semaglutide drugs, weight-loss medications also have been associated with potentially serious side effects — including suicidal thoughts, thyroid cancer and gastrointestinal problems, and pose a serious but little-known risk for pregnant women.

Accidental overdoses behind many of the calls to poison control centers

Semaglutide, first approved by the U.S. Food and Drug Association (FDA) in 2017 as a diabetes medication, works by reducing blood-sugar levels and slowing down the passage of food exiting the stomach, CNN and the BBC reported.

According to CNN, among the nearly 3,000 reports of semaglutide poisoning this year, many have involved accidental overdoses.

Julie Weber, director of the Missouri Poison Center, told CNN that as of October, it had received 94 calls relating to semaglutide this year, as compared to 28 calls for all of 2021. Dr. Joseph Lambson, director of the New Mexico Poison and Drug Information Center, told CNN semaglutide calls nearly quadrupled between 2021 and 2022.

CNN reported the largest increase in calls occurred among adults ages 40 through 70 and, in particular, the 60-to-69-year-old age group.

In remarks to CNN, Dr. Kait Brown, clinical managing director of America’s Poison Centers, said most calls this year concerned dosing errors.

In some cases, callers had to be “hospitalized for severe nausea, vomiting and stomach pain,” CNN reported. Other warning signs of a semaglutide overdose are dizziness or lightheadedness, feeling jittery, sweating and chills, irritability, headache, weakness, fatigue, nausea, seizures, confusion, hypoglycemia and passing out.

Semaglutide, a GLP-1 agonist, has been associated with potentially severe adverse events even in cases not involving overdoses.

According to JAMA Medical News, clinicians are increasingly observing more serious gastrointestinal side effects associated with Ozempic and Wegovy, in addition to self-harm behavior, anesthesia complications, serious vision problems and cancer cases among people taking the drugs to either to lower their blood sugar or lose weight.

The FDA said Ozempic and Wegovy may pose a risk to pregnant women and warned they should discontinue taking these medications at least two months prior to pregnancy. However, those warnings are buried and long-term testing won’t be completed for years.

Semaglutide also has been linked to an inducement of suicidal thoughts among some users, and to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstruction.

According to CNN, “There’s no specific antidote for a semaglutide overdose. The drug has a half-life of about a week, meaning it takes one week to clear half of it from your bod

Celebrity promotion of Ozempic leads to shortages, online black market

According to the BBC, demand for Ozempic “spiralled last year after it hit the headlines for being Hollywood’s secret weight loss drug — nicknamed the ‘skinny jab,’” because users must inject it.

In addition to celebrity endorsements, an “elite” and influential group of prominent doctors and obesity specialists have received nearly $26 million in payments from Novo Nordisk to promote weight-loss drugs in their lectures, treatment guidelines, clinics and medical societies, according to a Reuters investigation and a report by investigative journalist Lee Fang.

“After celebrities began openly embracing Ozempic on social media in 2022 as a way to lose weight, demand overwhelmed supply,” CNN reported, adding that the FDA officially recognized a shortage of the drug in 2022.

This opened the door for certain qualified pharmacies to make compounded versions,” according to CNN. It also led to a rise in off-label prescriptions for weight loss, which “triggered global supply issues and created a shortage for diabetes patients in the U.K,” the BBC reported.

There are differences between the patented and compounded versions of semaglutide, CNN reported, noting that compounded versions have often not been tested for safety and are frequently sold in unapproved dosages.

According to the BBC, “Doctors say drugs bought from unregulated sources are dangerous and could contain potentially toxic ingredients.”

The name-brand versions of semaglutide “are sold in pre-filled pens, which come with some safeguards,” but the compounded versions “typically come in multidose glass vials,” for which “patients draw their own doses into syringes.”

Packages delivered by mail usually contain needles and two vials — one containing a white powder and the other a liquid — which have to be mixed together before the drug can be injected, according to the BBC.

According to CNN, some callers to poison control centers overdosed despite using the pre-filled pens — in at least one instance “giving themselves an entire month of doses at once.”

The BBC reported that the hype surrounding the use of semaglutide for weight loss fueled an “online black market” driven by “unregulated sellers offering semaglutide as a medicine, without prescription, online,” in the form of “diet kits.” The drug was also “being offered in beauty salons in Manchester and Liverpool.”

“These compounded versions are popular because they may cost less out-of-pocket, especially if the treatment isn’t covered by insurance,” CNN reported.

In June, the FDA issued a warning against taking compounded versions of semaglutide if the prescription version is available, stating the agency received adverse event reports connected to administration of the compounded versions of the drug.

The FDA has also sent letters to two online sellers asking them to stop selling the drug. Novo Nordisk sued six medical spas, medical clinics and weight-loss clinics for selling knock-off versions of semaglutide.

According to CNN, data collected by poison control centers regarding reported symptoms of semaglutide do not provide a clear indication as to whether the patented or compounded versions were taken, “but some state poison center directors say they believe that compounded versions are behind many of the calls.”

Shortages spur new virtual weight loss management programs

The shortage of Ozempic and Wegovy also created difficulties for physicians, Medscape reported. Kevin Huffman, D.O., a board-certified bariatric physician and CEO of AmBari Nutrition told Medscape physicians “must now prioritize patients at the greatest risk who stand to benefit considerably — a complex decision-making process.”

Physicians also “face a bias from private insurers and Medicare,” who typically won’t cover weight loss medications for patients without Type 2 diabetes, and who “would prefer patients try and fail at every diet plan and weight loss medication, many with serious cardiovascular side effects, before being approved for newer drugs.” Huffman said.

The high cost of semaglutide has dissuaded employers and insurers from offering coverage for those drugs, Reuters reported.

Instead, companies like Boeing, Fortune Brands and Hilton “have signed up for or expanded deals with virtual healthcare providers,” who implement “weight-loss management programs” which “may require diet and exercise before granting access to the medicines.”

According to Reuters, drugs such as Wegovy “have list prices of more than $1,000 a month,” leading insurers like Blue Cross Blue Shield of Michigan to offer employers the option to sign their patients up for weight loss programs offered via virtual telemedicine platforms.

Reuters quoted Truist analyst Jailendra Singh, who forecast that the market for virtual obesity drug management may reach $700 million by next year and $9 billion “longer term.”

American Medical Association President Jesse Ehrenfeld, M.D., MPH, told Reuters that telehealth providers “should be a supplement to, not a replacement for, in-person provider networks” and that a reliance on telehealth may drive patients away from their current physicians.

But in a statement provided to The Defender, Brandon Welch, Ph.D., an associate professor in public health sciences at the Medical University of South Carolina and co-author of Telehealth Success: How to Thrive in the New Age of Remote Care, said “telemedicine has the potential to create better patient outcomes” regarding weight loss.

Potentially illegal advertising practices of semaglutide investigated by The BMJ

Despite shortages and the drugs’ high cost, companies like Novo Nordisk are reportedly planning to market drugs like Ozempic and Wegovy to children as young as 6, even though the drugs’ long-term risks are unknown and despite some experts’ warnings that the drugs may exacerbate our “toxic diet culture.”

Notably, in January, just weeks after the FDA approved Wegovy for use in children, the American Association of Pediatrics issued new childhood obesity recommendations, advising that children as young as 8 can be treated with weight loss drugs, including those containing semaglutide.

Novo’s new marketing plan comes despite an investigation by The BMJ finding inappropriate and possibly illegal marketing of semaglutide.

The BMJ’s investigation focused on the U.K., and according to Fierce Pharma, the findings “rais[e] questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment.”

According to The BMJ, online searches for terms like “Wegovy” turned up results including “pharmacy websites unrelated to the drugmaker,” some of which appeared to be directly marketing the prescription drug to consumers, which violates the U.K.’s Human Medicines Regulations 2012 and is illegal in most of Europe.

One such example was a blog post by Pharmadoctor, which according to The BMJ is “a website that supports pharmacists in providing services for patients.”

According to The BMJ, the Pharmadoctor post stated that “Wegovy is a weekly weight loss injection made famous by celebrities such as Elon Musk and Boris Johnson. If Wegovy is suitable for you, your pharmacist will be able to provide it.”

“With celebrity fans and proven weight management benefits, Wegovy is the weight loss jab that has everyone talking,” Pharmadoctor also stated.

Examples such as this led Shai Mulinari, Ph.D., associate professor of sociology at Lund University in Sweden, and Piotr Ozieransk, Ph.D., senior lecturer of social and policy sciences at the University of Bath in the U.K., to file a complaint Oct. 10 with the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), for the alleged illegal promotion of a prescription drug.

The complaint stated that they were “appalled” to find that Pharmadoctor was marketing Wegovy “directly to the public.”

In a response dated Nov. 22, the MHRA said that following an investigation, the Pharmadoctor page in question was “removed in line with our guidance.” But according to The BMJ, what Mulinary and Ozieranski discovered was that “a link and the word ‘Wegovy’ had been removed” but “the blog post remained online.”

The BMJ’s investigation found that the MHRA has not issued a single sanction for prescription drugs in the past five years. Among 16 cases where the MHRA took action by requesting changes to advertisements for weight loss drugs from June 2022 to July 2023, all were” triggered by external complaints, not internal mechanisms, and none resulted in sanctions.”

Dr. James Cave, editor in chief of the Drug & Therapeutics Bulletin, a BMJ journal with a focus on drug safety, filed multiple complaints about semaglutide advertising with the MHRA and the U.K.’s Advertising Standards Authority in the past year, but according to The BMJ “was disappointed with the results.”

For instance, the ASA “would not consider websites that were not being promoted through paid advertising on search engines,” while actions taken by the MHRA were often “minor,” sometimes involving “only a few words.”

Cave told The BMJ that such lax regulation and oversight creates only weak incentives for companies to follow regulations and abstain from the advertising of prescription drugs.

Regardless of how the drug is marketed, some doctors warn that reliance on medications to lose weight is dangerous.

In April, for instance, Dr. Joseph Mercola wrote,“By relying on medication to get thin, you rob your body of the chance to balance its weight naturally, in the way biologically intended, and expose yourself to untold side effects in the process.”