Growing public interest in injectable weight-loss medicines, including semaglutide products, has highlighted the importance of patient awareness, appropriate medical oversight and the use of medicines supplied through the formal regulatory framework.
Recent regulatory concerns in South Africa have drawn attention to the potential risks associated with unregistered or improperly supplied GLP-1/GIP injectable products, particularly where patients may not have clarity on a product’s origin, quality controls or appropriate use.
The issue is broader than any single supplier or product. For patients, the key consideration is whether a medicine has been reviewed by the appropriate authorities and is prescribed, dispensed and monitored through recognised healthcare channels.
Growing demand and patient awareness
The growing demand for these treatments has also created confusion for some consumers, particularly when products are promoted online or through wellness channels as easier or lower-cost alternatives to registered medicines.
Few medicines have generated as much public interest in recent years as semaglutide. Originally developed to help people with Type 2 diabetes control their blood sugar, it has also gained attention for its role in weight management. While demand continues to grow, there are currently no registered generic semaglutide products on the South African market.
This landscape is expected to change soon. Many pharmaceutical companies are expected to enter the market in due course, which should further expand patient access to registered, quality-assured medicines. For patients, the most important step is to speak to their healthcare professional about an appropriate SAHPRA-registered treatment option, rather than relying on unverified products or informal channels.
Safety concerns
While semaglutide itself has been extensively studied and approved for specific medical uses, experts say the real concern lies in where the product comes from, whether it has been properly assessed by regulators, and how it is being used.
Like all medicines, semaglutide can have side effects and should be used under the guidance of a healthcare professional. However, medicines that have not been properly reviewed by regulators, or that are taken without appropriate clinical oversight, may expose patients to additional and potentially serious risks.
This is according to Cindi Benjamin, Pharmacovigilance and Compliance Pharmacist at Pharma Dynamics – a leading pharmaceutical company within the pharmacovigilance sector. The distinction, Benjamin explains, is not between a medicine that is completely without risk and one that is unsafe, but between products that have undergone formal regulatory review and those supplied outside established quality, safety and monitoring systems.
“Patients may assume that all products marketed as semaglutide are equivalent, but that is simply not the case. A SAHPRA-approved medicine has undergone extensive evaluation for quality and efficacy. With unregistered products, there may be uncertainty around ingredients, sterility, potency, storage conditions and dose accuracy. These are particularly important considerations for injectable medicines.”
Before a semaglutide medicine can be approved by SAHPRA, manufacturers must submit evidence relating to quality and efficacy. This includes information on the active ingredient, manufacturing process and manufacturing site, quality controls, stability, labelling, dosing and clinical data. For injectable medicines, sterility, purity, dose consistency and cold-chain integrity are also carefully assessed.
International regulators have similarly cautioned patients and healthcare professionals about the risks associated with compounded or unregistered semaglutide products, including concerns around dosing accuracy and appropriate clinical oversight.
Clear dosing instructions, appropriate packaging and healthcare professional guidance are important safeguards, particularly for injectable medicines where incorrect administration may increase the risk of adverse effects.
Approved products are manufactured to defined specifications and supplied with standardised dosing information. Products supplied outside formal regulatory and quality systems may not offer the same level of assurance around consistency, storage, traceability or safe use.
What patients should look out for
Benjamin says consumers should be cautious about products promoted through social media, online sellers or unauthorised distributors. “Patients may be attracted by lower prices or easier access, but they should first confirm that the product has undergone formal assessment for quality and efficacy, and that it can be appropriately traced and monitored should a safety concern arise.”
Advice for consumers:
- Only use semaglutide that is prescribed and dispensed through a healthcare professional
- Confirm with your pharmacist that the product is SAHPRA-registered
- Avoid products sold via social media or unverified online platforms
As interest in semaglutide and other weight-loss medicines continues to grow, patients are encouraged to prioritise quality over convenience, seek guidance from a doctor or pharmacist, and verify that any medicine they use has been supplied through appropriate, regulated healthcare channels.
