FDA Warns Against Use of Compounded Versions of Ozempic, Wegovy
Consumers should be careful about the use of compounded versions of the diabetes drugs Ozempic and Wegovy, because they may be made with unauthorized and untested, ingredients, according to a new warning from federal drug regulators.
The U.S. Food and Drug Administration (FDA) issued a drug statement communication on May 31, warning about risks that may result from the increasing use of Ozempic and Wegovy for weight loss, which are often made by compounding pharmacies. However, the agency indicates that some compounding pharmacies are using unapproved versions of the active ingredient, semaglutide, which may put users at risk and which has been linked to adverse event reports from patients.
Ozempic (semaglutide) was originally approved for the treatment of people with Type 2 diabetes. However, in recent months Ozempic has been widely prescribed for weight loss. Although the diabetes drug Wegovy is approved for weight loss use, Ozempic is not and it is increasingly prescribed “off-label” as a diet medication.
Compounded Ozempic and Wegovy May Use Unsafe Ingredients
The move toward using the two drugs as weight loss treatments, as well as other supply chain factors, have resulted in a shortage of the two medications. During such shortages, compounding pharmacies may be allowed to make in-house versions of the drugs for customers, but they must meet FDA standards and use approved ingredients.
Both Ozempic and Wegovy are currently listed on the FDA’s drug shortage list, which makes them eligible for compounding. However, the FDA does not review compounded versions of medications on the drug shortage list for safety, quality or effectiveness, the FDA warns.
According to the FDA warning, the agency has received adverse event reports after patients used compounded versions of these drugs, and warns that it has also received reports that some compounding pharmacies are using a salt form of semaglutide, such as semaglutide sodium and semaglutide acetate.
The salt forms of semaglutide are different active ingredients than the semaglutide used in standard Ozempic and Wegovy, the agency warns. The FDA indicates it is unaware of any means of compounding the salt forms of semaglutide which would meet the agency’s requirements for compounding the two drugs.
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On April 27, the FDA sent a letter to the National Association Boards of Pharmacy, warning them about the problem.
“We are aware that in some cases compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate,” the agency wrote. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding.”
FDA Recommendations for Patients and Doctors
The agency does not say what kinds of adverse events have been reported in connection to the compounded drugs, nor does it say what types of adverse events may be linked to the use of semaglutide salts in compounded drugs.
The FDA warns patients to be aware of the risk of compounding pharmacies using semaglutide salts, indicating they have not been proven to be safe or effective. Patients should only obtain the prescription-only drugs with a prescription and from a licensed health care provider. They should also only use compounding pharmacies which are state-licensed, or outsourcing facilities registered with the FDA, the agency advises.
Healthcare professionals should also be aware of the problem if they are considering working with compounders to meet the needs of patients, the FDA advises.
Ozempic Hair Loss Concerns
The warning comes amid increasing reports that Ozempic side effects have been linked to hair loss when using the diabetes drug as a weight loss treatment.
Some doctors have claimed hair loss after Ozempic use is a natural result of rapid weight loss. This effect is known as telogen effluvium. However, Ozempic may also cause hormonal shifts which can also trigger early onset pattern hair loss in men and women, known as androgenic alopecia, which is progressive and continues to worsen over time. This can lead to permanent hair loss, some health experts warn.
Last month the founder of The American Hair Loss Association (AHLA) and The International Alliance of Hair Restoration Surgeons, warned against misuse of Ozempic for weight loss in an editorial in Dermatology Times, indicating that the hair loss experts do not recommend the off-label use of the diabetes drug.
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