FDA warns about safety of ‘off-brand’ versions of Ozempic, Wegovy
Written by ABC AUDIO on June 2, 2023
(NEW YORK) — Federal regulators are warning about safety concerns amid the rising popularity of drugs like Ozempic and Wegovy for weight loss.
The U.S. Food and Drug Administration is warning consumers that off-brand forms of the medications could be unsafe.
The warning comes as many people have reported turning to compounding pharmacies to get cheaper doses of semaglutide, the active ingredient in both Ozempic and Wegovy.
Without insurance coverage, the cost of medications like Ozempic and Wegovy can run more than $1,000 a month.
The FDA said it’s received reports of adverse events after people took semaglutide that came from a compounding pharmacy. It did not specify the number of reports or what the adverse events were.
“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 new safety warning this week.
The FDA also said that some compounding pharmacies claiming to sell semaglutide might instead be selling other formulations of the chemical, like semaglutide sodium and semaglutide acetate. Those haven’t been shown to be safe or effective, according to the FDA.
Compound versions of drugs are made for individual patients using 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.
Insurance coverage for Ozempic and Wegovy varies, depending on everything from a person’s medical diagnosis to where they live and their insurance plan.
Ozempic is approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss, as is permissible by the FDA.
Wegovy is FDA-approved for weight loss for people with obesity or who are overweight with a comorbidity like high blood pressure.
Ozempic and Wegovy are not currently covered for weight loss under most Medicare and Medicaid programs.
In addition to the high cost of the drugs, there have also been intermittent shortages of the drugs, which is also why some people have turned to compounding pharmacies.
In May, the FDA told ABC News’ Good Morning America that while the medications are eligible for compounding because of shortages, the compounded versions “pose a higher risk.”
“Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality,” the agency said in a statement at the time. “The FDA’s compounding program aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients.”
Experts say people who would like to take the brand names of the medications should check on their insurance coverage every few months because coverage may change.
Additionally, people should only use drugs that contain semaglutide with a prescription.
Purchasing medications online “can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards,” the FDA said in its warning this week.
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