ORLANDO, Fla. — Federal regulators are warning consumers about unapproved weight-loss injections sold online, citing concerns ranging from uncertain ingredients to dosing errors that have sent some patients to hospitals.
In a Sept. 24 warning letter, the Food and Drug Administration told the website Cheap Medicine Shop to stop offering unapproved and misbranded injectable semaglutide products to U.S. consumers.
The FDA’s letter warns that drugs sold outside regulatory safeguards could contain contaminants, incorrect ingredients or inconsistent amounts of medication.
Compounded does not mean FDA approved
Compounded drugs are prepared to meet particular patient needs. They do not undergo the FDA’s premarket review for safety, effectiveness and quality.
The agency says compounding can be appropriate when an available approved medicine cannot meet a patient’s medical needs.
Compounded products and counterfeit drugs are different categories. Counterfeits falsely claim to be authentic medicines.
As of May 31, the FDA reported 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.
Those reports do not establish that the medications caused every reported event or show the percentage of users affected. The FDA also says reporting is likely incomplete.
Dosing confusion can have serious consequences
In a separate safety alert, the FDA described patients taking five to 20 times their intended semaglutide dose after incorrectly measuring medication from multidose vials.
Reported problems included vomiting, abdominal pain, fainting and dehydration. Some patients required hospital care.
The agency identified confusion between milligrams, milliliters and syringe “units,” along with differing medication concentrations, as factors in the errors.
Patients using compounded injections should have their prescriber or pharmacist explain the exact dose and demonstrate how to measure it, according to the FDA.
Physician raises concerns about follow-up care
Dr. Nadav Fields, DO, an internal medicine physician, and his brother Jonathan M. Fields, DAOM, are co-founders of CR8 Health in South Florida. In statements provided to Channel 9, they raised concerns about medical oversight and where patients obtain weight-loss injections.
“We see patients who have been on these drugs for years on repeat refills, without seeing a physician and without labs. That is dangerous,” Fields said in a statement provided to Channel 9.
His observation describes patients he says his practice encounters; it does not establish how common that experience is among people using weight-loss medications.
Warning signs when shopping online
The FDA advises obtaining a prescription and using a state-licensed pharmacy.
Its listed warning signs include sellers that:
- Provide medication without appropriate medical screening or a prescription.
- Have no licensed physician available for follow-up questions.
- Claim a compounded product is identical to an FDA-approved drug.
- Send damaged packaging or medication without instructions.
Consumers can find more guidance through the FDA’s medication-safety resources.
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