SAHPRA Warns On Fake Versions Of Type 2 Diabetes Drugs Ozempic, Mounjaro

The South African Health Products Regulatory Authority (SAHPRA) shared its concern over the rise of counterfeit Glucagon-like Peptide (GLP-1) products like Ozempic in the local market across South Africa.

GLP-1 receptor agonists are drugs used to treat type 2 diabetes and obesity.

Ozempic is approved in South Africa for treating adults with type 2 diabetes to help lower blood sugar levels when diet and exercise alone are not enough. It is also approved to reduce the risk of major heart problems, like heart attacks, strokes or death, in adults with type 2 diabetes and heart disease. However, it is not approved for weight management in South Africa.

SAHPRA mentioned an increase in suspected counterfeit Ozempic, also known as semaglutide, which is one of the GLP-1 products registered by Novo Nordisk. In South Africa, Ozempic is available in two forms: a 0.25 mg and 0.5 mg/dose pen, and a 1 mg/dose pen, SA News reported.

The agency said these products - which help lower blood sugar and promote weight loss - are being sold to the public through websites, social media and other unofficial channels.

"These pose a health risk to the public. SAHPRA cautions the public to not purchase and/or consume such products as their safety, efficacy, and quality have not been assessed," SAHPRA said.

Mounjaro (tirzepatide), developed by Eli Lilly and Company, is also gaining attention in South Africa. It comes in pre-filled pens with different dosages, including 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg in a 0.5 ml solution for injection.

Mounjaro is approved for treating type 2 diabetes but has not yet been imported or made available in South Africa through Eli Lilly's distribution channels. Like Ozempic, the watchdog noted that Mounjaro is not approved for weight management in South Africa.

The complexity of making compounded GLP-1 agonists, which are sterile medicines with complex active ingredients, creates a public health and safety risk.

Compounded products that claim to contain semaglutide have not been verified or evaluated by SAHPRA to determine if the active pharmaceutical ingredient is identical to the registered one, as required by the Medicines Act.

SAHPRA also pointed out that using a product with an active ingredient not approved by SAHPRA is illegal under the Medicines and Related Substances Act. The public is urged to buy only SAHPRA-registered GLP-1 products to avoid these risks.

In August, President Ramaphosa signed the second Presidential Health Compact at the Union Buildings in Pretoria.