Ozempic isn’t approved for weight loss in Australia. So how are people accessing it?

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Ozempic Isn’t Approved for Weight Loss in Australia. So How Are People Accessing It?

Ozempic, a drug used to treat type 2 diabetes, has become a blockbuster medication globally, with millions of people worldwide using it to manage their weight. However, in Australia, Ozempic is only approved for the treatment of diabetes, not for weight loss. So, how are people accessing it for weight loss?

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The Rise of Ozempic: How Surprise Discoveries and Lizard Venom Led to a New Class of Weight-Loss Drugs

Ozempic’s rise to fame is attributed to its unique mechanism of action, which works by mimicking the natural hormone glucagon-like peptide-1 (GLP-1). This hormone is released by the gut in response to food consumption and helps regulate blood sugar levels. By mimicking GLP-1, Ozempic helps slow gastric emptying, reducing hunger and increasing feelings of fullness. Its efficacy in weight loss has led to a surge in demand, with millions of people worldwide using it off-label for weight loss.

How Doctors Are Prescribing Ozempic

Off-label prescribing is a common practice in medicine, where doctors prescribe a medication for a condition other than what it is approved for. In the case of Ozempic, doctors are prescribing it for weight loss, despite it not being approved for this indication in Australia. The Therapeutic Goods Administration (TGA) has stated that it does not have the power to regulate the clinical decisions of health professionals and is unable to prevent doctors from using their clinical judgement to prescribe Ozempic for other health conditions.

Why Can’t We Just Make More?

The active ingredient in Ozempic, semaglutide, is a delicate peptide molecule made up of two small chains of amino acids. Its manufacture is complex and requires specialized facilities beyond those used to make normal chemical-based drugs. Building new facilities to increase production takes time, which is why the shortage of Ozempic is expected to last until 2025.

Compounding Pharmacies Are Making Their Own

Compounding is the practice of combining, mixing, or altering ingredients of a drug to create a formulation tailored to the needs of an individual patient. In Australia, pharmacists are allowed to compound only when it is for the treatment of a particular patient to meet their individual clinical need and there is no suitable commercially manufactured product available. Compounded products are not held to the same safety, quality, and efficacy standards required for mass-produced medicines.

Compounded Ozempic-like products have become popular among weight-loss seekers, with pharmacies relying on these compounding rules to produce their own Ozempic-like products at scale and ship them to consumers around Australia. However, there are risks associated with using these products, as they have not been evaluated for safety, quality, and efficacy.

How the Regulator Plans to Tighten the Loophole

The TGA is taking steps to tighten the compounding loophole and has proposed removing GLP-1 drugs, including Ozempic, from Australia’s compounding exemptions. This would effectively ban pharmacies from making off-brand Ozempic. The proposal is currently under consultation, and a final decision is expected by June this year.

Conclusion

The use of Ozempic for weight loss in Australia is a complex issue, with doctors prescribing it off-label despite it not being approved for this indication. The shortage of Ozempic is expected to last until 2025, and the TGA is taking steps to tighten the compounding loophole. Compounded Ozempic-like products have become popular among weight-loss seekers, but there are risks associated with using these products.

FAQs

Q: Why is Ozempic not approved for weight loss in Australia?
A: Ozempic is only approved for the treatment of type 2 diabetes in Australia, not for weight loss.

Q: Why are doctors prescribing Ozempic for weight loss despite it not being approved for this indication?
A: Doctors are prescribing Ozempic for weight loss off-label, using their clinical judgement to treat patients with weight-related issues.

Q: What are the risks associated with using compounded Ozempic-like products?
A: Compounded Ozempic-like products have not been evaluated for safety, quality, and efficacy, and may pose risks to patients using them.

Q: What is the TGA doing to address the shortage of Ozempic?
A: The TGA is proposing to remove GLP-1 drugs, including Ozempic, from Australia’s compounding exemptions and is taking steps to tighten the compounding loophole.

Q: How can I access Ozempic for weight loss?
A: Ozempic is not approved for weight loss in Australia, and doctors are not prescribing it for this indication. If you are considering using Ozempic for weight loss, consult with your doctor to discuss alternative options.