- The FDA has issued a warning against GLP-1 drugs such as Ozempic and Wegovy.
- These drugs differ from FDA-approved Ozempic and Wegovy because they are available from online pharmacies and other unverified sources.
- These combination drugs are made by mixing or changing drugs to create the same drug as semaglutide.
The Food and Drug Administration (FDA) has issued a warning against the sale of modified glucagon-like peptide-1 (GLP-1) drugs such as semaglutide.
America is facing it.
As a result, online pharmacies and unverified sources are selling GLP-1 drugs made with different ingredients than those used in approved drugs.
These drugs are being marketed as semaglutide, which are called compound drugs due to mixing or changing ingredients to create drugs.
“Compounded drugs are not approved by the FDA, and the agency does not vouch for the safety or effectiveness of compounded drugs,” the FDA said.
The FDA issued the warning after the agency received reports of patients taking the combined semaglutide.
“Compounded drugs may contain unwanted contaminants or have unequal potency to FDA-approved drugs,” says Dr. Kelly Johnson-Arbor, MD, a medical toxicologist and associate medical director of the National Capital Poison Center.
Johnson-Arbor said there have been cases of people getting seriously ill and dying from other compounded drugs.
In some cases, compounded semaglutide medications are made from semaglutide salts, including semaglutide sodium and semaglutide acetate, which are different from the FDA-approved versions of semaglutide, which are sold under the brand names Ozempic and Wegovy.
According to the FDA, these saline versions have not been shown to be safe or effective.
It is also not clear what the health risks are.
“Essentially, you’re using a controlled substance, possibly smuggled into the U.S., with no control over what’s in it,” said Dr. Dan Azaguri, a professor of surgery at Stanford Healthcare.
The Pharmacy Compounding Association said in a statement last week that compounded semaglutide is technically not eligible for sale by compounding pharmacies.
Some compounded drugs can be legally prescribed by a licensed health care provider and sold in compounding pharmacies because they must meet “rigorous compounding standards.”
For example, people who are allergic to a certain dye can get a medicine made without it, Azaguri says.
But in this case, the actual semaglutide molecule can only be made by Novo Nordisk. If they don’t have enough, no one will get it,” Azaguri said.
David Lebo, PhD, RPH, professor of pharmaceutical sciences at Temple University’s School of Pharmacy, says that a compound should never be used as a substitute for a commercial product unless there are special reasons, such as Ozympic. administration, or to provide the drug to special populations
To avoid buying a compounded version of semaglutide, you must obtain your prescription only through a licensed healthcare provider and pick up the medication from a state-licensed pharmacy or facility registered with the FDA.
APC warns consumers to avoid unreliable online retailers.
“If your doctor has not written you a prescription for compounded semaglutide and referred you to a legitimate and reputable pharmacy, beware of the seller of that substance,” the APC states.
If you are buying your medicine online, make sure the retailer is licensed and regulated and that the medicines are manufactured by drug manufacturer Novo Nordisk.
For tips on evaluating the legitimacy of your online retailer, visit the FDA website
Non-legal versions of semaglutide tend to be cheaper.
“When searching for semaglutide online, look for clues such as ‘not for human use’ or ‘laboratory use only’ to identify formulations of the drug that are intended for research chemical use only and are not approved by the FDA for use in humans. ” says Johnson-Arbor.
If you have taken or think you have purchased compounded semaglutide, report the incident to the FDA
A certified health care provider can help find the drug with the right support during the follow-up process, Azaguri says.
If you can’t get semaglutide because of the shortage, there are many other drugs in this class, says Lebo.
“Patients should talk to their doctor or pharmacist about some of the options,” Lebo said.
Do not under any circumstances take fake or compounded semaglutide.
“You’re working to lose weight to improve your health so you don’t put yourself at risk by using these drugs,” Azaguri said.
The FDA has issued a warning about modified GLP-1 drugs being marketed, such as semaglutide. have been
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