The row over compounded weight-loss medicines is not unique to South Africa. It reflects a growing international challenge facing health regulators, according to an endocrinologist, Prof Tess van der Merwe, one of the country’s leading obesity and metabolism specialists.

Van der Merwe, who is an extraordinary professor of obesity care and a researcher at the University of Pretoria, said regulators worldwide are grappling with how to oversee the increasing use of GLP-1 medicines and similar therapies amid surging demand.

GLP-1 medicines are a class of drugs that mimic a naturally occurring hormone called glucagon-like peptide-1 (GLP-1). Originally developed to treat type 2 diabetes, some are now also used for weight loss.

Unlike registered medicines manufactured on a commercial scale, compounded medicines are individually prepared by pharmacists or licensed compounding facilities for specific patients.

Although limited injectable medications have been approved to treat obesity in South Africa, consumers are increasingly turning to compounded products because registered medicines can be expensive and are not always readily available.

While some of these formulations are not officially registered for weight loss, doctors sometimes prescribe them ‘off-label’.

While local authorities seek to manage these market pressures, Van der Merwe argues that the focus needs to shift toward the bigger picture.

Van der Merwe said the debate should extend beyond Sahpra’s recall of certain compounded iDEXIS products. “It is not about what is happening here in South Africa right now. It is not about what iDEXIS has done or not done. It is about controlling the future in a responsible and ethical manner,” she said.

Her comments follow a warning last week by the South African Health Products Regulatory Authority (Sahpra), the South African Pharmacy Council and the Health Professions Council of South Africa, instructing healthcare professionals not to prescribe, dispense or administer iDEXIS semaglutide, iDEXIS tirzepatide and iDEXIS semaglutide/tirzepatide recalled by Sahpra in June.

A global issue, not just a South African one

Van der Merwe said South Africa is facing the same regulatory challenges seen in countries including Australia, the UK and the US.

She added that, locally, regulators are not acting unusually but are responding to ‘extraordinary circumstances’ created by the growing popularity of GLP-1 medicines and the ease with which medicines can now be obtained outside regulated channels.

According to Van der Merwe, Sahpra still has a statutory responsibility to regulate Schedule 4 medicines, regardless of growing public demand.

“The public needs to be protected against the public,” she said, adding that many people underestimate the risks associated with obtaining medicines through unregulated sources.

Why regulators are concerned

Van der Merwe said one of the major concerns is that medicines affecting the GLP-1 pathway are prescription medicines backed by years of clinical research and regulatory oversight.

While these medicines have transformed obesity treatment, she cautioned that they are pharmacological therapies and should not be viewed as harmless simply because similar hormones occur naturally in the body.

“Using the argument of saying: ‘It’s something that’s physiological in my body and therefore can’t do me any harm,’ is an enormous misnomer,” she said, emphasising that these users are not using anything physiological; they are using something pharmacological.

She added that healthcare professionals also have legal and ethical responsibilities when prescribing Schedule 4 medicines.

Complications can be serious

Van der Merwe said GLP-1 medicines can cause serious complications if not used appropriately, including pancreatitis and, in rare cases, a form of sudden-onset vision loss that has been linked to these medicines.

She said this is one reason regulators are seeking tighter oversight as newer medicines in the same class continue to emerge.

The specialist also noted that obesity is recognised by the World Health Organisation as a chronic relapsing disease, but said misconceptions remain, with many people still viewing it primarily as a cosmetic issue rather than a medical condition.

Not ‘Ozempic copies’

Van der Merwe cautioned against describing compounded semaglutide and tirzepatide medicines as ‘Ozempic copies’ or ‘copycat medicines’. “They’re not copies. They’re peptide expansions.”

The comparison is misleading because compounded medicines are different from Ozempic, a prescription medicine registered by Sahpra to treat type 2 diabetes. Doctors sometimes prescribe Ozempic for weight management, even though it is not officially registered for that purpose. This is known as off-label prescribing.

Ozempic was not affected by last week’s recall.

iDEXIS Compounding had not responded to Caxton Network News’ emailed media enquiry by the time of publication.

Breaking news at your fingertips… Follow Caxton Network News on Facebook and join our WhatsApp channel.

Nuus wat saakmaak. Volg Caxton Netwerk-nuus op Facebook en sluit aan by ons WhatsApp-kanaal.