1 of 3 | Two weight-loss drugs approved by the Food and Drug Administration — semaglutide, or Wegovy, and tirzepatide, or Zepbound — are considered safe when prescribed by physicians, File Photo by Alexis C. Glenn/UPI | License Photo
The benefits of prescription weight-loss drugs for people with obesity override the risks, but compounded formulations of the medications can cause big problems, experts told UPI.
Two drugs approved by the Food and Drug Administration — semaglutide, or Wegovy, and tirzepatide, or Zepbound — are considered safe when prescribed by physicians, despite side effects, according to hospital pharmacist Suzanne K. Higginbotham. Advertisement
However, most overdoses have been reported with compounded formulations of the drugs administered at privately run weight-loss centers, said Higginbotham, a clinical pharmacist at The Ohio State University’s Division of General Internal Medicine clinics.
“Some weight-loss centers may be using compounded formulations of Wegovy or Zepbound,” Higginbotham told UPI in a phone interview.
“Compounded forms of the drugs are not FDA approved, so they’re not guaranteed to be safe or effective — they basically take the active ingredients [of these drugs] and mix up the formulation, so you don’t know exactly what’s in the medication.” Advertisement
Overdose reports
Semaglutide and tirzepatide are FDA-approved as prescription treatments for weight loss, and both were marketed originally to control blood sugar levels in people with Type 2 diabetes. For diabetes, semaglutide is sold as Ozempic and tirzepatide is known as Mounjaro.
As a weight-loss treatment, they are designed for people with obesity, or those who are severely overweight, Higginbotham said.
About 40% of adults in the United States are obese, the Centers for Disease Control and Prevention estimates.
But the concern about overdoses hangs over the heads of many users. Sometimes such overdoses occur because patients reason that if a certain amount can bring about weight loss at a given rate, then a larger dose can increase that rate, experts said.
Between Jan. 1 and Nov. 30 of last year, 2,941 semaglutide overdoses were reported nationally, according to America’s Poison Centers, a national nonprofit that represents 55 poison control centers in the United States.
Aside from potential overdoses, other effects of the weight-loss drugs are being reviewed.
For example, in a report released in early January, the FDA said it was investigating 201 cases of suicide or suicidal ideation among people taking medications that contain semaglutide or tirzepatide, although a preliminary evaluation of the latter “does not suggest a causal link,” it said. Advertisement
The agency also is also looking into 422 reports of hair loss among users of the drugs, it said.
“We encourage patients to use medications according to their FDA-approved labeling or healthcare provider instructions and to consult with their health care provider for any questions or concerns,” agency spokeswoman Chanapa Tantibanchachai told UPI in an email.
When a drug is not the drug
The weight-loss drugs are part of a class called GLP-1 receptor agonists, which means they are intended to mimic a gut hormone called GLP-1, which slows “gastric emptying,” or the process in which food moves through the stomach and digestive system, Higginbotham said.
“This makes people feel fuller quicker and not feel as hungry after eating, which helps promote weight loss,” she said.
Because of how these drugs work, they sometimes are associated with digestive-related side effects such as nausea, constipation and diarrhea.
Unfortunately, some of these “common” side effects are like the symptoms of overdose, which are “severe nausea, severe constipation and vomiting,” Higginbotham said.
“If [you’re using these drugs] and experiencing symptoms that are more severe than what you discussed with your physician, or if they come on abruptly, you should immediately seek care,” she added. Advertisement
Privately compounded formulations of semaglutide and tirzepatide include the main drug, but could be mixed with a “different” salt or prepared at a different dose than the FDA-approved versions, according to Higginbotham.
The FDA-approved formulations are the ones typically prescribed by a physician and dispensed at a pharmacy, she said.
Still, privately owned weight-loss businesses have suggested they plan to sell versions of these drugs that they have created themselves. Use of these compounded formulations is fueling many of the overdose reports, Higginbotham said.
Last month, the FDA issued a specific warning about use of compounded versions of semaglutide.
After an overdose
Ayman Dandashi, an ambassador for a cannabis company, was prescribed semaglutide for weight loss and “had an accidental overdose of the drug, which resulted in severe nausea, vomiting and stomach pain.”
“It was a terrifying experience,” he said, adding that he required medical treatment after the incident.
Dandashi said he hadn’t known about the risk before taking the drug, and believes his doctor prescribed a higher-than-recommended dose.
The starting dose for semaglutide is 0.25 milligrams once a week for four weeks, but it can be increased to 2.4 mg., according to the prescribing information.
Tirzepatide has a starting dose of 2.5 mg. weekly, but can be raised to 15 mg. Advertisement
Both drugs are typically dispensed with auto-injectors, which limit medication delivery to the prescribed dose to limit overdose risk, Higginbotham said.
“[These drugs are] intended to be used with diet and exercise, and they’re very safe and effective,” she said.
“It’s when patients are utilizing it not for the intended purposes that we see deleterious or adverse effects happening.”
