The Therapeutic Goods Administration (TGA) is warning consumers against taking EVE branded products that contain allylisopropylacetylurea (apronal) as they pose a significant health risk and are prohibited from sale, supply or use in Australia.
Apronal is a hypnotic sedative that was withdrawn from clinical use in Australia due to dangerous side effects and is banned in most countries in the world. It can go by many names including:
- apronalide
- ACE
- (2-Isopropyl-4-pentenoyl) urea.
Medicines and chemicals are classified into Schedules according to the level of regulatory control over the availability of the medicine or chemical required to protect public health and safety. Apronal is listed in Schedule 10 of the Poisons Standard, meaning that it is considered to be a substance of such danger to health as to warrant prohibition of sale, supply and use.
Apronal, has been found in a range of imported EVE branded products (not registered for use or sale in Australia) declared as allylisopropylacetylurea on the ingredients, including:
- EVE Quick for Headache
- EVE Quick for Headache DX
- EVE A
- EVE A EX.
The TGA reminds consumers and businesses that it is illegal to import, advertise or supply unregistered therapeutic goods in Australia.
Information for consumers
If you or someone you care for is taking EVE branded tablets containing allylisopropylacetylurea:
- stop taking them immediately
- take any remaining tablets to your local pharmacy for safe disposal
The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas websites as they:
- may contain undisclosed and potentially harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
Information for businesses
Importing and supplying EVE or any brand of apronal products in Australia is illegal and could result in a fine or court action.
The importation and supply of therapeutic goods must comply with legislation outlined in the Therapeutic Goods Act 1989. Generally, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported into Australia (unless they are exempt from being entered in the ARTG).
The TGA works with the Australian Border Force (ABF) to stop unlawful shipments, including medications that contain apronal from entering Australia. If these tablets are found at the border by the ABF, they will be seized and destroyed.
Report counterfeit medicines and medical devices
Follow these links if you are worried about counterfeit medicines or medical devices or you want to report a problem or side effect from using them.
You can also report a suspected illegal importation or supply of these products to the TGA using the report a breach form.