Falsified Ozempic products flood the market, Sahpra urges caution

The South African Health Products Regulatory Authority (Sahpra) has warned the public of falsified Ozempic products currently being sold on the market and online.

The regulator is warning the public to be wary of products claiming to be Ozempic (semaglutide), which are not approved by Sahpra.

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Ozempic is a Schedule 4, prescription-only medicine, authorised by Sahpra only for the treatment of type 2 diabetes mellitus in adults.

Sahpra has not authorised or registered Ozempic for weight-loss, therefore, use in that regard would be off-label, it said.

According to the regulator, only a healthcare practitioner can make a Schedule 4 product available off-label as they would provide the requisite guidance and support to the patient/individual.

Novo Nordisk South Africa, who is the Holder of Certificate of Registration (HCR), confirmed a national shortage of Ozempic stock, resulting in limited access to treatment for diabetic patients, said the Sahpra.

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“This may have created an opportunity for falsified/counterfeit products flooding the market claiming to be Ozempic and being used off-label for weight loss. Consumers should be wary of online offers for products claiming to be Ozempic or semaglutide,” said the Sahpra.

“Currently, there are no generic versions of this medicine being lawfully manufactured. Therefore, any product not manufactured by Novo Nordisk claiming to contain semaglutide is likely to be fake or counterfeit.

“The public is being exposed to many different types of unregistered/unauthorised products that are either substandard or falsified thereby putting their health at risk. See examples of registered vs counterfeit products.”

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The Sahpra has warned that using unregistered semaglutide products claiming to have the effects of Ozempic bought from unverified/illegally trading suppliers could be detrimental to your health as these have not been evaluated by the regulator for safety, quality and efficacy.

“These falsified/fake Ozempic products may contain certain active ingredients found in the registered Ozempic products; however, the formulations or manufacturing processes may be different. These formulations have not been evaluated by Sahpra,” it warned.