FDA Warns Against Off-Brand Semaglutide Drugs Amid Shortages, Safety Concerns
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The U.S. Food and Drug Administration has issued a warning against using off-brand Wegovy and Ozempic drugs because they could be dangerous and ineffective.
Both semaglutide medications have risen in popularity this year for weight loss, causing a shortage of the drug in the marketplace and allowing for compounding pharmacies to make replacement medicines.
The FDA received several reports of adverse effects from people who used compounded semaglutide. In some cases, compounders used the salt forms of semaglutide, which have different active ingredients than the approved drug, according to the agency.
“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 wrote.
There are presently three semaglutide medicines available with a prescription in the U.S. and there are no generic versions. The FDA-approved products are:
- Ozempic Injection and Rybelsus Tablets: Approved for lowering blood sugar levels in adults with Type-2 diabetes, alongside diet and exercise.
- Wegovy Injection: Approved for weight loss in adults and children over 12 who are obese or overweight, accompanied by weight-related medical conditions and combined with diet and exercise.
Semaglutide belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists. The medicine mimics the GLP-1 hormone that is released into the gastrointestinal tract in response to eating. It can then interact with the parts of the brain that reduce appetite and signal fullness, according to the FDA.
Online Pharmacies and Semaglutide
In June, drugmaker Novo Nordisk sent out a warning that a counterfeit Ozempic injection pen was found in the U.S. It was sold by a retail pharmacy and contained another type of diabetes medication, insulin glargine injection, that works differently. This led to an adverse reaction, according to Novo. The company is investigating.
“Medications purchased online or in-person from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe,” Novo warned. “Purchasing and administering counterfeit, illegal and unapproved medications from online or in-person unlicensed or foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.”
Some users have turned to online compounding pharmacies to obtain semaglutide medicines at a lower price. Natosha Cooke told Drugwatch she saw via social media the success others were having with semaglutide and wanted to try it.
“I’ve had a really great experience,” said Cooke, a 38-year-old mother of three from Bozeman, Montana. “I’ve had no negative side effects.”
Cooke sought a prescription from an online compounding pharmacy in spite of knowing the risks and hearing the warnings. The FDA urges patients to purchase medicine like semaglutide from licensed health care providers and only purchase medicine from state-licensed pharmacies or outsourcing facilities that are registered with the FDA.
“Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards,” the FDA stated. “If you choose to use an online pharmacy, FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.”