Product pulled from shelves in South Africa due to severe safety risks
The rapidly growing weight-loss drug market in South Africa is currently under strict investigation.
The South African Health Products Regulatory Authority (SAHPRA) has issued an urgent recall of compounded GLP-1 medicines.
These products include compounded versions of well-known weight-loss and diabetes medications, such as Ozempic, Wegovy, and Mounjaro.
The manufacturer of the recalled medicines is iDexis, which operates as Sentra Pharmacy in Pretoria.
SAHPRA, along with the South African Pharmacy Council (SAPC) and the Health Professions Council of South Africa (HPCSA), has now issued a warning to the public, pharmacies, and medical practitioners.
Doctors and pharmacists have been advised against the continued use, prescription, or dispensing of the recalled products, including:
- iDEXIS Semaglutide
- iDEXIS Tirzepatide
- iDEXIS Semaglutide/Tirzepatide combination products
“The continued use, prescription and dispensing of these products pose a severe risk to patients’ safety and/or users,” said SAHPRA.
SAHPRA said that any healthcare professional found to have dispensed, prescribed or kept stock of the recalled products will face disciplinary action in accordance with applicable legislation, including the Medicines and Related Substances Act, 101 of 1965.
The regulators said that in a Class I, Type A Recall, SAHPRA determined that iDEXIS Semaglutide, iDEXIS Tirzepatide and iDEXIS Semaglutide/Tirzepatide pose a serious safety risk to patients.
Therefore, any professional found to be prescribing or dispensing them to patients or users will knowingly endanger the public’s health.
The warning has been issued following a High Court interim order granted last month, which prohibits iDexis from manufacturing and selling medicines containing semaglutide.
This order resulted from a lawsuit filed by Novo Nordisk, the exclusive manufacturer of Ozempic.
The Danish pharmaceutical company contended that iDexis was illegally producing and selling unregistered semaglutide products, thereby competing in South Africa’s rapidly expanding weight-loss market without adhering to the necessary medicine regulations.
Semaglutide is the key ingredient in Novo Nordisk’s Ozempic and Wegovy drugs, while tirzepatide is found in Eli Lilly’s (LLY.N) blockbuster Mounjaro and Zepbound.
The South African Pharmacy Council CEO, Vincent Tlala, told Reuters that regulators had escalated the matter because, to their knowledge, iDexis had not carried out the recall as required.
He said that pharmacists dispensing the recalled products could face fines ranging from R25,000 ($1,531.43) to R75,000.
If an investigation determines that members of the public have suffered harm as a result of using these medications, practitioners could be removed from the council’s register following a disciplinary hearing.
Following last month’s ruling, Sara Norcross, the general manager for Novo Nordisk South Africa, said that the judgment highlighted the risks associated with unregulated compounded versions of GLP-1 medications.
Ozempic
Ozempic (semaglutide) is available as an injection (0.5 mg, 1 mg, or 2 mg) and as tablets (4 mg or 9 mg).
These prescription medications are intended for use alongside diet and exercise to improve blood sugar levels (glucose) in adults with type 2 diabetes.
The Ozempic Injection is used for reducing the risk of major cardiovascular events, such as heart attack, stroke, or death, in adults with type 2 diabetes who have known heart disease.
It is also used to reduce the risk of worsening kidney disease, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.
Ozempic tablets are used for reducing the risk of major cardiovascular events, such as heart attack, stroke, or death, in adults with type 2 diabetes who are at high risk for these events.
The manufacturer Novo Nordisk stated that the safety and effectiveness of Ozempic injections and tablets in children have not been established.
On its official website, Novo Nordisk stated that Ozempic may cause serious side effects, including pancreatic inflammation (pancreatitis).
The manufacturer also warned against possible thyroid tumours, including cancer, which can occur.
Research involving rodents has shown that Ozempic and similar medications may lead to thyroid tumours, including thyroid cancer.
It remains unclear whether Ozempic can cause thyroid tumours or a specific type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans.
The full recall notice can be viewed below.
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