Almost half of online pharmacies selling weight loss drugs are operating illegally, study finds

Consumers trying to buy popular weight loss drugs online without a prescription risk being scammed or getting unsafe products, a new study shows.

About 42% of online pharmacies that sell semaglutide, the active ingredient in Novo Nordisk’s anti-obesity drug, Wegovy, are illegal, operating without a license and selling drugs without instructions, according to a study published Friday in JAMA Network Open.

People shopping online for weight loss drugs “face serious consumer risks” of getting “ineffective and dangerous products,” said Tim Mackey, report author and professor of in global health at the University of California, San Diego, as well as director of the Global Health Policy and Data Institute. The study involved researchers from the University of Pecs in Hungary.

The shortage of popular weight-loss drugs, which belong to a class of drugs called GLP-1s, has led to an “illegal black market,” said Dr. Christopher McGowan, founder, medical director and research director of True You Weight. Loss, weight loss clinic in Cary, North Carolina.

“This is very scary,” said McGowan, who was not involved in the investigation. Illegal drugs “expose patients to the risks associated with unregulated, low-quality, potentially contaminated products. It cannot be expected that an ordinary person will navigate this internet site, that is why it is better to stick to the brand name, medicines approved by the FDA,” he said.

The popularity of semaglutide has increased in recent years, with more than 2.5 million prescriptions filled in the US by December 2023, according to a separate study published on Friday in the JAMA Health Forum.

Manufacturers can’t keep up with demand for the drug, which can cost $1,300 a month out-of-pocket, and many who can’t find drugs in their pharmacies are turning to online vendors and telehealth.

Many buy online for semaglutide, also sold as Ozempic to treat Type 2 diabetes, because their insurance plans won’t cover the shots or because their doctors won’t write them a prescription. , Mackey said.

Medicare does not cover drugs when prescribed for weight loss, and many state Medicaid plans severely restrict coverage. Most people receiving GLP-1 prescriptions have private insurance, according to a JAMA Health Forum study.

“It’s no surprise that people would turn to the internet for alternatives,” McGowan said. “Unfortunately, this is where unscrupulous sellers prey on desperate people.”

Illegal pharmacies pose safety risks

In Mackey’s study, he and his colleagues tested samples of semaglutide ordered from six online pharmacies for quality and safety.

Two online pharmacies received warning letters from the Food and Drug Administration last year for the illegal sale of unapproved and mislabeled semaglutide.

One vial of semaglutide had high levels of endotoxin, a toxin found in bacterial cells, although the researchers did not find any live bacteria that could cause an infection. Being injected with endotoxin, which may have come from environmental pollution during production, can make people feel sick.

Online prices sampled in the study contain up to 39% more semaglutide than indicated on the label, which can lead to overdose.

An overdose of semaglutide can cause severe nausea and vomiting, as well as dangerous drops in blood sugar, which can lead to fainting, according to the FDA.

From January to November 2023, poison control centers across the US reported nearly 3,000 calls related to semaglutide, an increase of more than 15 from 2019. The majority of overdoses resulted from dosing errors made. they are drug addicts.

Wegovy and Ozempic, both made by Novo Nordisk, are sold in easy-to-use injection pens. Off-brand versions of semaglutide — which can come from compounding pharmacies or study-reviewed pharmacies — often come in vials that require consumers to fill the syringe with the correct amount.

On its website, Novo Nordisk says patients can spot counterfeit medicines by looking for certain signs, such as misspelled or unsealed packages, or prices that seem too good to be true. .

In a statement, a company spokesperson said patients should know that Novo Nordisk is the only drug manufacturer in the US that makes an FDA-approved drug with semaglutide.

“Telehealth providers and compounding pharmacies that claim to supply or sell unapproved products that claim to contain ‘semaglutide’ source their ingredients from organizations other than Novo Nordisk,” it said. advocate.

Internet

Some so-called online pharmacies take customers’ money but don’t dispense the drugs, according to the study.

Although Mackey and the study’s co-authors paid for six orders, they received only three. The three websites they ordered from were “non-deliverable scams,” asking for additional payments of $650 to $1,200 to help their products “clear customs,” according to the report.

In the worst-case scenario, consumers who buy GLP-1 drugs from illegal online pharmacies are “losing their money,” said Shabbir Safdar, executive director of the Partnership for Safe Medicines, which conducts research. on the dangers of synthetic drugs. In the worst case scenario, you end up with potentially dangerous medications.

Some people who cannot find semaglutide in their regular pharmacy have turned to pharmacies that mix, combine or change the drug ingredients to make medicines that suit the specific needs of the patient. Legal compounding companies do not dispense drugs without a prescription, said Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding, an industry group.

Compounded drugs can be manufactured and distributed with fewer restrictions when the drug appears on the FDA’s drug shortage list, the agency says; currently, several Wegovy values ​​are missing. However, the FDA cautions that “combination drugs should only be used for patients whose medical needs cannot be met by an existing FDA-approved drug.”

In a statement on its website, Novo Nordisk said it was working to resolve the shortage. “While we will do our best to support those who want to start taking Wegovy, it is important to note that overall demand will continue to outstrip supply and some patients may still struggle to fill prescriptions of Wegovy,” the statement read in part.

Safdar said that buying compounded semaglutide has risks compared to brand-name brands.

People who have made dosing errors while dispensing semaglutide from compounding pharmacies have been injured and even hospitalized after accidentally taking too much, according to an alert issued last week by the FDA.

Brunner said consumers should only buy drugs from compounders who are licensed by their state board of medicine.

Under ideal circumstances, deciding whether to take a GLP-1 drug is a complex medical decision and patients need to be closely monitored, said McGowan, of True You Weight Loss. Consumers will not receive such care if they buy drugs online without seeing a health care provider.

Even when taken as prescribed, GLP-1 drugs can cause many side effects, including nausea, diarrhea, vomiting, constipation, abdominal pain, headache, and fatigue. most people stop taking them after two years. The FDA advises health care providers to closely monitor patients for kidney disease, eye disease, depression or suicidal behavior or thoughts.

Some doctors have also noted that GLP-1 drugs can cause eating disorders in some patients, and the American Association of Eating Disorders Associations, whose members provide treatment or support to people who have an eating disorder, recommend that doctors check people for conditions such as anorexia before giving them prescriptions. semaglutide.

“If a chemical doesn’t require a prescription, a medical evaluation or any understanding of your health, it’s not the right thing to do,” McGowan said.

“Right now, there are no shortcuts,” he said. “You’re either lucky enough to get insurance for GLP-1 drugs, or you’re willing and able to pay hundreds, if not thousands, of dollars a month for money. There is currently no proven, safe method.”