The controversy surrounding the success of weight loss achieved using the diabetic drug Ozempic continues… dodgy websites have started springing up in South Africa, selling similar injections to customers who are ignorant of the serious concerns surrounding the drug and its use. Paola Chellew talks to Dr Cecile Baard to get the hard facts.
There are so many methods of losing weight, and many of the solutions – from diets and exercise to fasting and food tracking apps – do not always achieve success. The latest weight management phenomenon to go viral is the quick-fix weight-loss injection method, which places semaglutide, more widely known as the diabetic drug Ozempic, at the centre of the weight-loss debate.
Now, Ozempic, a drug for diabetic use, has the side effect of allowing users to lose a large amount of weight in a relatively short time. Miraculous, right? But as consumers, we need to be aware of the facts, medical and legal, including the pros and cons of using the drug, and whether it is sustainable on a long-term basis.
An interview with Dr Cecile Baard follows…
Please define the term semaglutide and what it does.
Dr Baard: Semaglutide, registered as Ozempic, was approved by the USA’s FDA in December 2017 for use in adults with diabetes type 2. It has been registered in South Africa by SAHPRA (South African Health Products Regulatory Authority) since July 2020.
It is a GLP-1 (glucagon-like peptide 1) agonist drug, which means it mimics the natural hormone that regulates hunger and satiety. The active ingredient also lowers blood sugar levels by helping the pancreas produce more insulin, thereby preventing the liver from releasing too much sugar. It also slows down the rate at which food travels through the digestive tract.
What product containing semaglutide has SAHPRA registered?
Dr Baard: In South Africa, we only have two registered pre-filled injectable pen presentations of Ozempic, the 0.25 mg and 0.5 mg dose pen and the 1 mg dose pen. Each 1.0 ml solution contains 1.34 mg semaglutide.
What is Ozempic used for in South Africa?
Dr Baard: In South Africa, Ozempic is registered for the treatment of adults with diabetes type 2 where other medications do not sufficiently control the sugar or glucose levels. It is used as an adjunct to proper diet and exercise. It is also registered for use in the reduction of stroke, heart attack, and death in adults with diabetes type 2 with known heart disease.
Is it registered in SA for weight loss?
Dr Baard: No, Ozempic is not registered as a weight-loss drug in South Africa; therefore, use in that regard would be considered off-label. It is critical to note that only a healthcare professional can make a Schedule 4 drug available off-label, as they would have to provide guidance and support to the patient. We would only do this if an obese patient has enough severe comorbidities, such as heart disease, where losing weight would help in limiting these conditions.
Is it available on prescription only?
Dr Baard: Ozempic is a Schedule 4 prescription-only medicine. It has to be prescribed by a registered medical doctor. There are no generic versions available.
Where else can you get it?
Dr Baard: You can only get registered, approved, and legal Ozempic from registered and licensed pharmacies or dispensers.
Unfortunately, there are numerous dodgy online sites, as well as private individuals (on Facebook and other social media platforms), selling illegal versions of the drug. They call it Ozempic or Izempic.
Who should administer it?
Dr Baard: Patients administer the Ozempic themselves once a week. When a medical doctor prescribes Ozempic, they will show the patient how and where to inject, as well as the correct disinfecting procedures to follow.
Who are the ideal candidates for semaglutide injections?
Dr Baard: Only adults with diabetes type 2 and uncontrolled glucose/sugar levels or with known heart disease.
Can semaglutide be compounded, and is it in the same form as that used in Ozempic?
Dr Baard: Semaglutide may be compounded because it is included in a medicine that has been registered by SAHPRA. However, the compounded medicines must be in accordance with the conditions and requirements contained in the Medicines and Related Substances Act (Medicines Act) and its regulations.
The compounded medicine cannot be in different forms from the registered product. It cannot contain salts, such as semaglutide acetate, semaglutide sodium, or any form apart from the semaglutide in the registered product.
SAPHRA has not evaluated the safety and effectiveness of the salt forms of semaglutide.
Take us through what is legal in terms of the Medicines Act.
Dr Baard: The Medicines Act provides a system of licensing for manufacturing and dealing with medicines. It intends to allow for the registration of drugs intended for human use and for the establishment of a Drugs Control Council.
If any other forms of semaglutide (other than the semaglutide that is in the registered product) are used in the compounded medicine, it will be illegal and is not permissible in terms of Section 14(4) of the Act.
In addition, Novo Nordisk South Africa, the company holding the certification of registration, has confirmed a national shortage of Ozempic; therefore, ethically, we limit the prescription to patients with uncontrolled diabetes type 2.
This has created an opportunity for falsified or counterfeit products that are flooding the market.
What are the contraindications and side effects of Ozempic?
Dr Baard: Ozempic should not be used without being prescribed by your doctor. There are various contraindications and side effects, some of which may be life-threatening.
Side effects include nausea, vomiting, diarrhoea, bloating, constipation, stomach pain, and depression. Ozempic is relatively new, and the effects of years- or decades-long use are largely unknown.
Serious side effects include:
- Pancreatitis (severe stomach pain that may spread to the back, with or without vomiting).
- Kidney disease (persistent nausea and vomiting may lead to dehydration and worsening of existing kidney problems).
- Gallbladder problems, including gallstones and inflammation of the gallbladder.
- Serious allergic reactions such as swelling of the face, lips, tongue, or throat with difficulty breathing.
- Risk of hypoglycaemia (low blood sugar, which can be life-threatening).
- A very dangerous side effect with reported fatalities (death) is paralytic ileus or intestinal (bowel) obstruction.
- Thyroid tumours – the package insert clearly warns against using Ozempic if you have a personal or family history of medullary thyroid carcinoma (cancer).
- People preparing for colonoscopies have suboptimal bowel prep and may need repeat procedures due to the drug’s effect of delaying the emptying of the gastrointestinal tract.
It must also most certainly not be used if you are pregnant or breastfeeding.
What else should patients know?
Dr Baard: Products claiming to contain semaglutide may not contain the same active ingredient, semaglutide, as the SAHPRA-registered product. Compounded products or products obtained outside legitimate sources (registered and licensed pharmacies and dispensers) may contain the salt forms of semaglutide described earlier that have not been reviewed by SAHPRA for safety and efficacy.
If you purchase medicines from unregulated and unlicensed sources, this can lead to the use of falsified or substandard medicines that have not been tested or verified, which may be harmful.
In South Africa, online pharmacy webpages are linked to a physical pharmacy, so make sure you check that the website is owned by a physical, licensed pharmacy.
If you buy medicines outside the legal supply chain, be aware of the following:
- It may not contain any active ingredient.
- It may contain dangerously high levels of the active ingredient.
- It may contain other active ingredients, such as insulin.
- It may contain harmful inactive ingredients.
- It may be nonsterile and contaminated with microbes and, therefore, not suitable for injection.
We see various names like Wegovy, Saxenda, and Victoza all over social media. Are they the same as Ozempic, and are they available in SA?
Dr Baard: Victoza, Saxenda, Wegovy, and Ozempic are all GLP-1 agonist drugs. Victoza is registered for insulin resistance and diabetes type 2. Only Saxenda is registered for weight loss in South Africa.
Wegovy is registered for weight loss, but is not available in South Africa yet.
In terms of maintenance and cost, how sustainable is a weight-loss injection?
Dr Baard: We get excellent results with Saxenda, but the weight loss will not be permanent if you do not change your eating habits and adopt a healthy lifestyle. People can maintain their weight if they stay on these injections, but once they stop, they can easily gain all the weight back if they do not make lifestyle changes.
Moreover, it is very expensive. Saxenda can cost up to R5 000 per month or more for the optimum dose. At a registered pharmacy, Ozempic can be between R1 500 and R3 000 depending on the dose. Victoza and Ozempic are covered by some medical aids when motivated by specialists and accompanied by blood results. Saxenda is not covered by medical schemes at all.
What has SAHPRA done so far to address the concerns surrounding counterfeit goods surrounding Ozempic?
Dr Baard: SAHPRA issued a media release on 11 December 2023 about falsified Ozempic products being sold. It warned the public to be wary of products claiming to be Ozempic, and advised that no lawfully manufactured generic versions are currently available in South Africa.
It warned that counterfeit products may be available in cartridges or vials other than the 1.34 mg/ml pens registered, and that the naming might be slightly spelt differently. See examples of registered vs counterfeit products.
SAHPRA is monitoring the supply chain and internet for unregistered/unauthorised, substandard, and falsified products claiming to contain semaglutide. They are also investigating any contraventions relating to the Medicines Act committed by healthcare professionals or the public.
How do you report dodgy online sites selling injectable pens containing semaglutide?
Dr Baard: Anyone who is aware of any contraventions or online advertising of Ozempic is encouraged to report these to SAHPRA’s 24-hour hotline (0800 204 307) or via its online reporting portal.
To conclude
From the author’s point of view, one more notable aspect in terms of aesthetics is the concern about losing a large amount of weight in a short time. This may lead to other unwanted side effects like sagging skin, decreased elasticity, and the loss of facial fat – which has actually been dubbed “Ozempic face”. These all increase the unwanted signs of ageing.
Perhaps we might look to wise words from the past in driving our decision-making in this context. In the words of the learned Greek philosophers – all things in moderation. And find your balance; there certainly is a lot to weigh up.