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People who are desperate to take Ozempic-like drugs are at ‘risk, warns FDA
The rush for weight loss drugs like Wegovy and diabetes drugs like Ozempic (which is also used for weight loss) has drained Novo Nordisks supplies of each, meaning pharmacies have had to make up the shortfall by combining, mixing, or altering other drugs to meet demand.
US regulations allow this, but the FDA warns that unapproved versions of weight loss drugs (and others) can be risky for patients, since they dont undergo the same levels of review. The Focus previously reported on a group of Harvard experts stark warning against the dumpster fire of knock-off drugs fuelled by anti-obesity stigma, and the hysteria around Ozempic, Wegovy, and others. Increased access to the real deal may save thousands of lives, but resorting to copies brings serious health risks.
People taking Ozempic copies are at risk, as deaths mount
Novo Nordisk, the Danish pharmaceutical company that makes weight-loss injection Wegovy and diabetes drug Ozempic, is aware of 100 hospitalizations and 10 deaths resulting from people taking copies of its popular drugs.
The company has been looking at a number of compounded products in the market and identified multiple safety concerns, the Business Standard reports.�
In October 2024, the FDA updated a report detailing its concerns with unapproved drugs used for weight loss. Both Wegovy and Ozempic are semaglutides and have been in short supply in the US until recently.
As a result, compounding pharmacies have been copying them by combining, mixing, or altering ingredients to meet the demand.
Why has demand been so high? Partly because of the drugs high publicity successes, partly because of a diet culture-driven frenzy, in the view of science professor and pediatrician S Bryn Austin. Both drugs have been runaway successes, along with Mounjaro.
But there are drug-free ways to lose weight and other weight-loss medications currently in development.
Dosing errors partly to blame for hospitalizations from Ozempic and Wegovy copies
If a patients medical need cant be met by an FDA-approved drug, regulations exist that allow third parties to copy brand-name medications.
However, the FDA writes, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.
The agency has received multiple reports of adverse events 346 with compounded semaglutide, as of August 31, 2024. Some have required hospitalization. It suggests that these have been the result of dosing errors from patients measuring and self-administering incorrect doses of the drug.
In some cases, healthcare professionals may also have miscalculated doses of the drugs in question.
Some of the adverse events are serious, the agency adds, and some patients reported seeking medical attention for their symptoms, including nausea, vomiting, diarrhea, abdominal pain and constipation.
Beware counterfeit medications and report issues to the FDA
Besides technically legal but unregulated copies of drugs like Ozempic and Wegovy, the FDA says its aware of counterfeit Ozempic being marketed in the US.
Counterfeit drugs are those that claim to be authentic, it warns, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients, and are illegal.
The agency urges people to be vigilant and only buy medications from state-licensed pharmacies. That way, everything will be above board, and the drugs are more likely to be safe.
If youre aware of any adverse events or quality problems with products like Wegovy or Ozempic, or indeed any medications, the FDA encourages people to report to its MedWatch Adverse Event Reporting program, either by submitting a form online or downloading it and submitting it via fax to 1-800-FDA-0178.
