Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Consumers and health professionals are advised that the TGA is undertaking a comprehensive review of the safety of therapeutic goods containing both caffeine and oxedrine. Oxedrine is found in the herb Citrus aurantium (also known as bitter orange).
Caffeine and oxedrine (along with some other herbal stimulants) are found in a range of health products currently available in Australia. These goods are variously marketed as energy supplements, appetite suppressants and weight loss products.
The TGA is aware that some of these products are used and marketed as recreational stimulants. Such use could create significant health risks, especially if used in combination with illicit drugs or other stimulants. These concerns are particularly relevant at this time, as the end of the school year - and celebrations often associated with it - are approaching.
The TGA has received reports of adverse events after consumption of products containing both caffeine and oxedrine, including a report of teenagers experiencing serious cardiovascular toxicity after using such a product in combination with alcohol and additional caffeine from an energy drink.
Please report all suspected adverse events involving products containing both caffeine and oxedrine to the TGA.
Information for consumers
This monitoring communication only highlights a potential safety concern.
However, you should be aware that there have been reports in Australia of adverse events with use of products that contain both caffeine and oxedrine. Potential adverse events include fainting, increased heart rate, raised blood pressure, stroke and heart attack.
You are advised to avoid use of products that contain both caffeine and oxedrine in combination with alcohol and additional caffeine or other stimulants.
Parents of teenagers are also advised to discuss this issue with them, especially in terms of any end of school year celebrations.
The risks may be increased if you have a known heart condition and/or high blood pressure, or if you use other products that can increase your heart rate (including medicines, energy drinks and other caffeine-containing products).
You should carefully read the labels of all health products and foods, including those marketed as energy supplements, and are encouraged to moderate your caffeine intake. Currently in Australia, there is no recognised health-based safe limit for caffeine intake.
If you have any questions or concerns about this issue, contact your health professional.
Information for health professionals
Note the above information and consider advising your patients of this issue.
Consider advising patients to carefully read the labels of all health products and foods, including those marketed as energy supplements, as well as to moderate their caffeine intake. In particular, advise patients to avoid use of products containing both caffeine and oxedrine in combination with alcohol and additional caffeine or other stimulants.
Similarly, consider advising parents of teenagers to discuss this issue with them.
Patients with heart conditions and/or high blood pressure may be at increased risk of serious adverse events, including tachycardia, arrhythmias and potential cardiac arrest.
In patients presenting with signs or symptoms consistent with caffeine toxicity, consider the possibility that it may be due to the use of products containing both caffeine and oxedrine, as well as other stimulant combinations.
Please report to the TGA all suspected adverse events involving products containing both caffeine and oxedrine experienced by your patients.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.