The “knock-off” drugs may be ineffective with no active ingredients, at all. Those designated as “not for human consumption” or “for research purposes only” can be deadly in an unsupervised setting.
The warning
Compounded drugs, which are a particular focus of the warning, are those that are mixed or “compounded” at the individual pharmacy. The FDA warned that unapproved versions of GLP-1 receptors, including semaglutide and tirzepatide can be risky for patients, as unapproved versions do not undergo the FDA’s review for safety, effectiveness and quality before they are marketed.
As of November 30, 2024, the FDA had received more than:
- 392 reports of adverse events with compounded semaglutide; and
- 215 reports of adverse events with compounded tirzepatide.
These adverse effects may be under-reported because the law does not require state-licensed pharmacies to report them to the FDA.
Dosing errors
Many of the reported events appear to be consistent with dosage issues, potentially because of patient errors, or errors on the part of health care professionals. However, they may also be due to compounded products containing more than the FDA-approved dosage or which call for dosing more frequently than recommended. Reported symptoms have included nausea, vomiting, diarrhea, abdominal pain and constipation.
Wrong form of the drug, banned drugs
The FDA has also warned that some semaglutide products sold by compounders may be the salt forms of the drug. These salt forms, including semaglutide sodium and semaglutide acetate, are different drugs, and they have active ingredients other than those that are used in the approved medications. They may not have the same chemical and pharmacological properties as the active ingredient in branded Ozempic.
The warning notes that retatrutide cannot be used in compounding under federal law. Additionally, it is not a component of an FDA-approved drug and has not been found safe and effective for any condition.
Counterfeits
The FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients. They are illegal.
The agency investigates reports of suspected counterfeit drugs to determine the public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats.
Illegal online sales of counterfeit drugs
The FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. These illegally marketed drugs:
- may be counterfeit;
- could contain the wrong ingredients or harmful ingredients; or
- may contain too little, too much or no active ingredient at all.
Additionally, the warning notes that the sterility of needles from counterfeit products cannot be confirmed, which presents an additional risk of infection for patients.
Cost is a real concern for many Ozempic patients, but remember that if the price seems too good to be true, the product you are getting may not be what you think it is.
Not all compounded drugs are harmful
A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye or an elderly patient or a child who cannot swallow a tablet or capsule and needs it in liquid form. Medical professionals in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.
How can consumers protect themselves
READ MORE OZEMPIC AND MOUNJARO LEGAL NEWS
The FDA recommends three steps that patients can take to protect themselves:
- Patients should always obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy;
- Visit FDA’s BeSafeRx campaign for resources to safely buy prescription medicines online; and
- Talk to your doctor if you have questions about your medicines.
In addition, it is very important that you discuss any side-effects you experience while taking GLP-1s with a medical professional. Information about the dangerous side-effects of even the approved forms of these weight-loss drugs is still emerging.
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