NEW YORK, Aug. 14 (Xinhua) -- As a game-changing new class of injectable diabetes and obesity drugs surges in popularity, widespread shortages and steep prices for brand-name GLP-1 drugs have persisted, pushing droves of weight-loss hopefuls into a booming, less regulated secondary market for copies that are more affordable and readily available online, reported Los Angeles Times on Wednesday.
Compounded drugs, as they are called, are not approved by the Food and Drug Administration (FDA), meaning the agency does not verify their safety, effectiveness or quality, noted the report. Although compounded forms serve an important role in the pharmaceutical industry, there are also risks -- concerns that have grown in the Ozempic era as telehealth startups, med spas and online pharmacies proliferate, eager to get in on the craze.
"We urge patients to be vigilant," said a spokesperson for the FDA, which has issued several alerts and letters recently about concerns related to compounded semaglutide. However, the caution always falls into void, as Ozempic costs over 1,000 U.S. dollars per month, while the alternatives only sell at 300 to 400 dollars but with almost the same weight-losing effect.
"Unfortunately, a lot of patients are doing that legwork on Reddit or TikTok and they're getting awful advice. I spend half my time trying to differentiate between some of the sketchy stuff that is going on online," Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, was quoted as saying.
In the pharmacy sector of the United States, there is a stark reality: compounding is legal and has been around for decades. A drug may be compounded for a patient who, for example, is allergic to a dye in the brand-name drug or needs a medication to be made in liquid form instead of a pill. They are also allowed when an FDA-approved drug is on the agency's drug shortage list.
What's more, in the hierarchy of the country's pharmaceutical industry, compounds occupy a widely misunderstood spot. They are not generics, which the FDA considers to be "bioequivalent" to name-brand drugs, and which undergo review by the agency and are permitted to be sold after patents expire.
The FDA encourages consumers to carefully research online pharmacies. It has provided tips, such as buying only from a business that requires a doctor's prescription, is licensed with a state board of pharmacy and has a licensed pharmacist on staff to answer questions. ■