Is berberine listed by the Therapeutic Goods Administration (TGA)?

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Last updated: April 17, 2025View editorial policy

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From the Research

Berberine is not listed on the Australian Therapeutic Goods Administration (TGA) register as an approved therapeutic product. This means it is not officially recognized or regulated as a prescription medication in Australia. Berberine is a plant alkaloid found in various plants like barberry, goldenseal, and Oregon grape, and is commonly sold as a dietary supplement rather than a registered medicine. Since it's not TGA listed, healthcare providers in Australia cannot prescribe it as a conventional medication, and any berberine products available would be classified as complementary medicines or supplements.

Key Points to Consider

  • The current evidence base for berberine shows promising results in some studies for conditions like diabetes and high cholesterol, but lacks the comprehensive clinical trial data required for full therapeutic approval 1.
  • Berberine has been shown to have a glucose-lowering effect, which is related to the baseline fasting plasma glucose (FPG) and HbA1c levels of patients 1.
  • Treatment with berberine may be safe since it does not increase the incidence of total adverse events and the risk of hypoglycemia 1.
  • Consumers should be aware that supplement quality and content can vary significantly, and they should consult healthcare providers before using berberine, especially if taking other medications, as it may have interactions with drugs like cyclosporine, certain antibiotics, and blood thinners.

Mechanism of Action

Berberine has been shown to have a wide range of pharmacological properties, including anti-inflammatory, anti-diabetic, and anti-lipidemic effects 2. It has been found to inhibit the voltage-gated k+ channels of pancreatic β cell membrane and promote insulin secretion without causing hypoglycemia 1.

Clinical Use

While berberine is not approved as a therapeutic product in Australia, it may be used as a complementary medicine or supplement. However, consumers should be aware of the potential risks and interactions with other medications, and consult with healthcare providers before using it.

Safety and Efficacy

The safety and efficacy of berberine have been evaluated in several studies, including a systematic review and meta-analysis of randomized controlled trials 1, 3. These studies have shown that berberine is generally safe and effective in reducing glucose and lipid levels in patients with type 2 diabetes. However, more research is needed to fully establish its safety and efficacy as a therapeutic product.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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