SACRAMENTO, Calif. —
In 2021, the FDA approved Wegovy, a medication specifically for chronic weight loss management in adults. It's the first drug of its kind since 2014 and Wegovy maker Novo Nordisk says “at least 25,000 new U.S. patients starts on Wegovy weekly," and the number is growing.
Semaglutide is an active ingredient in Wegovy and a second drug made by Novo Norodisk named Ozempic. Semaglutide mimics a type of hormone our gut produces when we eat a meal. It sends signals to different organs when we eat. It tells us when we are full and suppresses appetites. It's also known to slow down gastric emptying, so you feel fuller longer.
Wegovy uses a prefilled pen to dose injections weekly. Without insurance, Wegovy costs about $1,350 for a month supply, totaling to more than $16,000 a year. While some pay with their insurance, many are struggling just to get their prescriptions filled. Heightened demand created a semaglutide shortage.
Those who can’t get their hands on the brand name or afford it have been turning to an alternative called compounded semaglutide. Patients are given a vial and needle to administer the drug themselves, which has led to accidental errors. It's caught the attention of poison control.
NEW DATA TRENDING IN THE WRONG DIRECTION
"I can say the majority of these accidental exposures are from using the product like that is compounded,” said Justin Lewis, a pharmacist and director of the California Poison Control System Sacramento-Division.
He says poison control has seen an increase in semaglutide exposure calls since 2018.
"People are seeking it from compounding pharmacies or buying it over the internet. When you get it that way, it's often in a multi-dose vial that the patient has to draw up and inject themselves," he said.
Lewis explains it’s the #1 reason why semaglutide exposures are happening in patients calling into poison control. In 2018, the California Poison Control System received approximately 30 calls. By 2021, it increased to over 100 and calls jumped to over 350 in 2023. Poison control is now forecasting an increase in calls.
"The majority of the calls are just really severe. Gastrointestinal, nausea, abdominal pain, vomiting and then sometimes to the point where they just can't keep anything down, get too dehydrated, have to go to the hospital," he said.
Lewis adds a majority of callers are accidentally administering too much of the medication, but other patients lack patience.
“Some patients don't want to wait that long, so they just start on the higher dose and then immediately have much more serious gastrointestinal symptoms," he said.
The increase in calls prompted the California Poison Control System to take a closer look at semaglutide cases. Their goal is to figure out why these errors are happening.
"Is it because it's an accident? They misunderstood the directions? Really trying to hone in on why specifically these errors are occurring so that we can then focus education efforts to try to prevent these from occurring," he said.
Among concerns about compounding this weight loss medication is counterfeit semaglutide. In fact, counterfeit semaglutide has flooded the market.
Novo Nordisk, the manufacturer of the Wegovy, has filed 21 legal actions against medical spas, weight loss clinics, pharmacies and other companies that have “engaged in deceptive, unfair, unlawful, and dangerous practices regarding the marketing and sales of alleged “semaglutide” products...”
After testing, the company found some of the compounded drugs had no semaglutide. Another lawsuit alleges an online retailer was selling semaglutide “to patients without any prescription from a medical professional."
COMPOUNDED SEMAGLUTIDE
Semaglutide is on the FDA’s shortage list, which means compounding pharmacies are allowed to compound semaglutide.
Dr. Masoud Rashidi is the owner of Innovative Compounding Pharmacy in Folsom, an accredited sterile compounding pharmacy that’s been around since 2007. Rashidi says this is the first time in 17 years where he’s seen an overwhelming number of requests for a drug.
"We get like 10 to 15 calls a day," said Rashidi.
Innovative Compounding Pharmacy is one of two sterile compounding pharmacies in the area that can compound and fill prescriptions for semaglutide.
"We do a lot of testing. I know there are bad apples out there, so make sure you call your pharmacy or whoever you're getting it (from) or doctors. Just make sure they're doing their job and make sure what you're getting is a good product just to be safe," Rashidi said.
The FDA released guidance on using compounded semaglutide saying, in part, “FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient.”
While compounded drugs are not FDA approved, Rashidi says his compounding pharmacy only works with licensed sellers and continuously does testing on the products they receive. He says his pharmacy has spent over $10,000 on testing alone.
“We are going above and beyond doing every test possible," he said.
Rashidi says patients should know getting semaglutide requires a prescription.
"Stay away from the online stuff that you don't really know where it's coming from. If it doesn't have a pharmacy name or doctor's name, it's a red flag already," Rashidi said. “It's just not about price, sometimes it's your life and your safety.”
CONNECTING WITH A TRUSTED DOCTOR
Dr. Adeela Ansari is an endocrinologist with 17 years of experience. She says taking semaglutide isn't that simple.
"There's no such thing as magic drug. You have to have a comprehensive knowledge on what it takes to lose weight and maintain weight," said Ansari.
Weight loss even with semaglutide requires a lifestyle change from the foods you eat to increased physical activity. Perhaps one of the biggest factors patients should pay attention to is dosing the injection.
"The key for this medication is to really start low dose and have (the) patient acclimate to it," said Ansari.
Semaglutide has a long half-life. Ansari says it can take anywhere from two to three weeks before the medication is out of your system, which is why she suggests patients should connect with a licensed health care provider who has knowledge of how the medication works and can track progress.
Working with a health care provider you trust, getting a basic lab workup and monitoring any new onset symptoms are the green flags patients should look for.
"I think my biggest concern is those online pharmacies and just making the right choices," said Ansari, adding her take home message is patients should always speak with a provider who knows and understands you health conditions.
WATCH MORE ON ABC10: Medical provider sees high demand for weight-loss injections
