What you need to know about side effects of GLP-1 drugs
A class action lawsuit has been filed over alleged side effects of GLP-1 drugs such as Ozempic, Wigovy, and Munjaro.
Many Americans seeking popular weight loss drugs like Wegovy and Zepbound are turning to telemedicine companies like Hims & Hers for cheaper, compounded alternatives.
These combination drugs were only intended to be widely available during a time when popular brand-name drugs were in short supply. Although the Food and Drug Administration has declared the shortage will end in 2025, telemedicine companies still sell compound versions of anti-obesity drugs, adjust the drugs to different doses, and often sell them at lower prices than drug companies charge for brand-name drugs.
Novo Nordisk, the maker of Wegobee, recently sued Hims & Hers, and the telemedicine provider called the lawsuit a “blatant attack” on Americans who rely on compounded weight loss drugs.
According to KFF, a health policy nonprofit, about 1 in 8 Americans takes GLP-1 drugs for weight loss, diabetes or other conditions. And many customers whose insurance plans don’t cover the drugs have a hard time affording these drugs.
Novo Nordisk and Eli Lilly have lowered prices for consumers whose insurance plans do not cover these drugs. These cash-paying customers can buy Wegovy and Zepbound from drug companies, telemedicine portals, retail stores like Costco and Sam’s Club, or the Trump administration’s direct-to-consumer site TrumpRx.
But in the wake of Novo’s lawsuit and federal drug regulators threatening enforcement action, will companies cut back on sales of cheaper, formulated versions of popular weight loss drugs like Wegoby and Eli Lilly’s Zepbound?
Novo Nordisk Group General Counsel John Kuckelman told USA TODAY, “We hope that all compounders involved in bulk compounding will heed this legal action.” “We expect them all to be mindful of the potential consequences of continuing their actions.”
Why is Novo Nordisk filing a lawsuit now?
Novo Nordisk sued Hims & Hers on February 9, alleging that the telemedicine company infringed Novo’s patents by selling a version of Wegovy.
The lawsuit comes less than a week after Hims & Hers announced plans to sell a combined version of Wegovy at an introductory price of $49 per month. Days later, the company canceled its plans after the FDA threatened to take action against Hims & Hers.
Novo Nordisk officials said Hims & Hers’ announcement to launch a tablet version of Wigobee was a last resort. Novo Nordisk officials said that, unlike injectables, there was no shortage of Wegoby tablets and there was no need to sell a combination drug.
“There’s no excuse. There’s no argument that the shortage is the cause,” Kuckelman said. “And frankly, this was outrageous. Not only does this infringe on patents that we take very seriously, but it is a direct challenge to the entire U.S. drug approval framework.”
Hims & Hers officials declined an interview request, but said in a statement that treating obesity requires “accuracy and individualization.” The company still sells GLP-1 injections.
Hims & Hers said it has approximately 2.5 million subscribers across its health products. The company says GLP-1 customers represent a “minority” of its subscribers.
“Limited access, excessive costs, and standardized approaches are not prerequisites for quality care,” Hims & Hers said. “Our rigorous customer-first approach removes the friction of traditional medicine and puts ownership of health back where it belongs: with the consumer.”
Wegovy is the only GLP-1 obesity treatment approved by the FDA
Novo is the only company to receive FDA approval for a GLP-1 weight loss drug. This gave Novo an exclusive window to sell the pills to consumers who want to lose weight without using injections.
“The oral version[of Wegovy]is a great marketing opportunity for Novo Nordisk,” said Howie Forman, director of the MD/MBA program at the Yale School of Management. “Certainly, oral administration is preferable to injection for a significant number of people.”
During an earnings conference call with investors in February, Novo executives emphasized the importance of quickly launching the company’s oral drug. They said an additional 50,000 prescriptions for oral Wegoby are being refilled each week. Additionally, 9 out of 10 consumers who filled prescriptions in the first few weeks paid with cash.
Wegovy pills have a starting price of $149, about $200 less than the injectable version.
Novo won’t have this exclusive sales opportunity forever. Eli Lilly’s weight loss drug Orforglipron could receive FDA approval in April.
Forman said consumers are likely already benefiting from lower prices due to intense competition. Both Novo and Lilly’s weight loss drugs have list prices of more than $1,000, but consumers with insurance can typically pay much less in co-pays and other out-of-pocket costs.
A study by benefits consultant Mercer found that 49% of large employers will cover GLP-1 drugs in 2025, up from 41% in 2023.
Novo and Lilly are also offering discounts for customers paying cash. Lilly announced that customers who purchase a one-month supply of 2.5 mg single-dose vials of Zepbound will now pay $299, a $50 reduction from the previous price of $349. A 5 mg vial costs $399.
Novo has reduced the price of its injectable Wigovy and most Ozempic doses from $499 to $349 per month for consumers who purchase the drug directly from drug companies, telemedicine partners, or retail pharmacies.
“The actual price to consumers for all of these drugs has fallen significantly over the last year,” Forman said. “(Prices) are expected to continue to fall.”
Federal drug regulators are also putting pressure on compounders.
After Hims & Hers first announced plans to offer a version of its Wegovy tablets, the FDA announced it would “take decisive action” against companies that use GLP-1 ingredients in mass-market sales of combination drugs.
“These actions are intended to protect consumers from drugs whose quality, safety, and effectiveness cannot be verified by FDA,” the FDA said.
On February 6, Health and Human Services General Counsel Mike Stewart said the agency had referred Hims & Hers to the Department of Justice for an “investigation into possible violations” of federal Food, Drug, and Cosmetic Act.
Novo announced that its own tests have found that the ingredients used to make the formulated version of Injectable Wegovy contain up to 86% of impurities. Novo said the combination pill version of the drug contained as much as 75% impurities.
The company said that even small amounts of impurities in medicines can adversely affect the safety and effectiveness of the medicine.
Novo officials contrasted the safety and efficacy standards that FDA-approved drugs such as Wigovy and Ozempic must meet before they can be legally sold. Telemedicine companies and compounding pharmacies do not have to undertake extensive medical research to prove to the FDA that their drugs are safe and effective.
“We have to go through decades of testing, research and investment, as well as the effectiveness and safety of how we use and manufacture the drug,” Kuckelman said.
Hims & Hers defended its safety practices. The company said its formula ingredients are sourced from FDA-registered factories and are accompanied by documentation showing that each batch of ingredients has been tested for impurities.
“We only work with licensed pharmacy partners who maintain high quality standards,” Hims & Hers said.
Other companies selling weight-loss services say pharmacies will continue to provide an important service for patients.
Dr. Michael Snyder, an obesity expert at Future Health, said pharmacies can tailor medications for people who can’t tolerate typical doses. He gave the example of someone who was prescribed a customized statin drug to treat high blood pressure.
But the popularity of weight loss drugs has brought about something completely different.
“We’re in the wild west here when it comes to these GLP-1 drugs,” said Snyder, medical director of HCA HealthOne Rose’s Bariatric Surgery Center.
Snyder said patients need more than just weight loss drugs to control diseases such as obesity. He said too many companies are selling these prescription weight loss drugs without proper medical supervision.
Some patients may not eat enough nutritious food while taking the drug. Others may experience side effects, which can be managed by adjusting the dose, he said.
“My job is to keep people on a path to healthy weight loss,” Snyder said. “I think anyone can lose a lot of weight, but it takes a little bit of effort to do it in a healthy way.”
Contact consumer health reporter Ken Alltucker at alltuck@usatoday.com..
