FDA warns about safety of "off-brand" versions of Ozempic, Wegovy

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Federal regulators warn of safety concerns due to the growing popularity of weight-loss drugs like Ozempic and Wegovy.

The US Food and Drug Administration is warning consumers that off-brand forms of the drugs may not be safe.

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 drugs like Ozempic and Wegovy can exceed $1,000 a month.

The FDA said it has received reports of adverse events after people took semaglutide sourced from a compounding pharmacy. He did not specify the number of reports or what the adverse events were.

“Patients should not use a compound drug if a drug approved for a patient’s treatment is available. Patients and healthcare professionals should understand that the agency does not review compound versions of these drugs for safety, efficacy, or quality,” the FDA said in a new safety advisory this week.

The FDA also said that some compounding pharmacies that claim to sell semaglutide may instead sell other formulations of the chemical, such as semaglutide sodium and semaglutide acetate. Those haven’t been proven to be safe or effective, according to the FDA.

Compound versions of the 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 efficacy.

There are currently no generic versions of the semaglutide drugs, 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.

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Ozempic is approved by the FDA to treat type 2 diabetes, but some doctors prescribe the drug “off-label” for weight loss, as permitted by the FDA.

Wegovy is FDA-approved for weight loss for people who are obese or overweight with comorbidities like high blood pressure.

Ozempic and Wegovy are currently not covered for weight loss by most Medicare and Medicaid programs.

Mario Tama/Getty Images

A box of the diabetes drug Ozempic sits on the counter of a pharmacy, on April 17, 2023, in Los Angeles.

In addition to the high cost of the drugs, there have also been intermittent shortages of the drugs which is why some people have turned to compounding pharmacies

In May, the FDA told “Good Morning America” ​​that while the drugs can be combined due to shortages, compounded versions “pose a higher risk.”

“Compound drugs pose a greater risk to patients than FDA-approved drugs because compound drugs do not undergo FDA premarket review for safety, efficacy, 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 legally marketed compounded drugs for patients.”

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Experts say people who would like to take the drug’s brand names should check their insurance coverage every few months because coverage could change.

Also, people should only use medications that contain prescription semaglutide.

Buying drugs online “may expose patients to potentially unsafe products that haven’t undergone proper evaluation or approval, or that don’t meet quality standards,” the FDA said in its advisory this week.

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