The popularity of the drugs, combined with uneven insurance coverage, has given rise to a cottage industry of online retailers and medical spas that purport to provide “generic Ozempic” at discounted prices. Some require only a cursory medical consultation. Others forgo it altogether.
Consumers should be extremely wary. “Generic Ozempic” is a misleading term because Ozempic’s manufacturer, Novo Nordisk, still has patent exclusivity. Ozempic, the brand name for semaglutide used to treat diabetes, and Wegovy, the name for obesity treatment, have been approved by the FDA. (Ozempic is also prescribed off-label for weight loss, and “Ozempic” has often been used colloquially to describe the class of drugs that includes semaglutide.) Generic medications also require FDA approval, but the knockoff versions being distributed have not gone through that process.
Rather, knockoffs are made through a procedure called compounding, which allows pharmacies to tailor medications for patients with specific clinical needs. For example, an individual with an allergy to one component of a commercially available drug can request a compounding pharmacist to reformulate the medication without that ingredient.
Some larger compounding facilities are subject to direct FDA oversight, though most compounders are regulated by states. According to the FDA, “some states may have insufficient resources to adequately oversee them.” Importantly, compounded medications are not approved by the FDA for quality, effectiveness or safety.
Compounding meets an important need for a small subset of patients, but it inherently carries additional risk. This is particularly true for sterile injectable drugs such as semaglutide. In 2012, a Massachusetts compounding pharmacy distributed a contaminated steroid injection. More than 750 people in 20 states developed fungal infections including in their brains, spinal cords and joints. At least 100 people died. The FDA has also reported instances of patients overdosing on compounded drugs such as fentanyl and ketamine because of inaccurate dosing and labeling.
Compounders can legally get around the market exclusivity for FDA-approved Ozempic and Wegovy because they are on the agency’s drug shortage list. It’s understandable that patients seeking these drugs are tempted by this option, given how expensive and scarce the medications are, but they must be aware of the increased risk. Here are five steps to consider:
Don’t buy from illegally operated websites. Semaglutide is a prescription medication. Online services that sell it without physician consultation are doing so illegally. Consumers can also check the list maintained by the National Association of Boards of Pharmacy of websites that sell fraudulent and unsafe medications.
Verify the active ingredient. The FDA-approved semaglutide is a “base” form. This is different from “salts” such as semaglutide acetate or semaglutide sodium, which are available for research purposes and used by some compounders. The FDA has warned that the salt versions do not meet federal requirements for compounding. Patients should not take them, and they should stay away from vials labeled “for research use only.”
Check to see whether the compounding facility has had violations. Patients should ask where their compounded product was made. Check first to make sure the facility is accredited for compounding and then cross-reference it against the FDA’s list of pharmacy violations. It’s best to avoid compounders with a history of violations. However, just because a facility isn’t listed doesn’t mean it hasn’t had problems; it’s possible that violations were not reported to the FDA.
Beware of unsubstantiated claims. Many compounders add ingredients such as vitamin B12 and the amino acid derivative L-carnitine and advertise that they lessen side effects of semaglutide. These claims are unsubstantiated, and there have been no human studies to determine the safety of these combinations.
Double-check instructions. A recent journal article reported three cases of adverse events because of dosing errors. Two patients self-administered 10 times the prescribed amount by accident. Novo Nordisk’s semaglutide is dispensed as a prefilled injection pen, while compounders provide syringes and a vial from which patients draw themselves. Speak with the pharmacist and be sure how much to use.
For months, the FDA has raised alarms about reported adverse events in patients who used compounded semaglutide. Its guidance is unambiguous: “Patients should not use a compounded drug if an approved drug is available to treat a patient.”
Manufacturers should expedite increasing supply to meet the overwhelming need. In the meantime, patients must exercise caution. That begins with asking a simple question: Am I confident that what I’m taking is really Ozempic or Wegovy?
