The U.S. Food and Drug Administration has issued a new warning about a popular weight-loss drug.
The FDA said it has received reports of people overdosing on the compound semaglutide, taking up to 20 times the intended dose of the drug.
The incidents, some of which required hospitalization, involved semaglutide that was taken from a vial and given by injection, according to the FDA.
The agency said dosing errors are the result of both patients measuring and self-administering incorrect doses of the drug, as well as health care providers “miscalculating” doses of the drug.
“Based on adverse event reports, many patients who received compounded semaglutide vials were inexperienced with self-injection,” the FDA said in a July 26 statement. “Unfamiliarity with withdrawing medication from a vial into a syringe and confusion between different units of measurement (e.g., milliliters, milligrams, and “units”) may have contributed to dosing errors.”
The agency said patients should consult a health care professional about how to measure and administer the correct dose, and that health care providers should “provide patients with the appropriate syringe size for the intended dose and advise patients on how to measure the intended dose using the syringe.”
Semaglutide is the active ingredient in three FDA-approved drugs, Wegovy, Ozempic, and Rybelsus.
While the FDA-approved drugs are administered either as oral tablets or in prefilled pens, the compounded versions of semaglutide require patients to withdraw the dose themselves from vials, which can lead to dosing errors.
Symptoms of a compound semaglutide overdose include nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones, according to the FDA.
People should contact their health care provider if they experience symptoms.
The FDA also encourages people to report “adverse events” and “medication errors” to the agency through its online portal or by downloading and faxing an adverse event report.
The FDA has previously warned against the use of the compound semaglutide, citing safety concerns.
Compounding pharmacies create their own compounds of semaglutide or tirzepatide from raw ingredients. They are not the same as generic drugs, which are FDA-approved and monitored for safety and effectiveness.
There are currently no generic versions of semaglutide medications, including Ozempic and Wegovy.
“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in a safety warning earlier this year.
The warning came as many people reported turning to compounding pharmacies to get cheaper doses of semaglutide.
Without insurance coverage, the cost of medications like Ozempic, Rybelsus, and Wegovy can exceed $1,000 per month.
Ozempic and Rybelsus are both FDA-approved to treat type 2 diabetes, but some doctors prescribe the drug “off-label” for weight loss, as allowed by the FDA.
Wegovy is FDA approved for weight loss in people who are obese or overweight with a comorbidity such as high blood pressure.
ABC News
