Australia will ban pharmacies from creating replicas of popular weight loss drugs like Ozempic, following reports of dangerous side effects, including one patient’s hospitalization for a “serious adverse incident.”
Pharmacies will be restricted from making GLP-1 receptor agonist products — a class of drugs that help manage blood sugar levels — for individual patients, Health Minister Mark Butler announced in a statement Wednesday.
This change will close the loophole that previously allowed the creation of Ozempic-like products without Australian regulatory approval.
More than 20,000 Australian patients have been using these imitation drugs, largely to try to lose weight, according to Butler.
“While I understand that this action may concern some people, the risk of not acting is far greater,” he said. “You only have to look to the recent reports of individuals impacted by large-scale compounding to realize the dangers posed.”
Booming demand for weight loss drugs like Novo Nordisk’s Ozempic has led to shortages around the world. Some users report side effects including nausea. A May poll of US consumers found that one in eight had tried some variation of the new class of drugs.
A spokesperson for Novo Nordisk emphasized that compounded semaglutide products pose a “potential significant safety risk” and should not be prescribed to patients.
“We do not, and will not, support any type of non-indicated (off-label) use of a Novo Nordisk product at any time,” the spokesperson said.
The Australian government’s move has the support of the country’s Therapeutic Goods Administration. Similarly, the US Food and Drug Administration has warned about the dangers of injecting some compounded products after adverse incidents in America.