New Warning on Counterfeit Botox
A new warning has been issued regarding counterfeit Botox products imported into Australia. This follows an initial alert six months prior from the national medicines regulator.
Identified Products and Risks
The Therapeutic Goods Administration (TGA) reported that fake Botox vials mimic the packaging of genuine products from Allergan Aesthetics, a division of AbbVie. AbbVie confirmed that products with batch number C8478C4 are not genuine. These counterfeit items were reportedly bought online from an overseas website, not from an Australian pharmacy.
Counterfeit products lack assessment for quality, safety, or efficacy, posing significant public health and safety risks.
Consumers are advised to avoid using Botox products with these batch numbers and to dispose of them safely at a local pharmacy.
Previous Warnings and Seizures
The TGA initially warned about counterfeit Botox in July last year after two batches (C7211C4 and HA 33946) were seized at the Australian border. Inconsistencies like spelling errors and incorrect formatting were noted on the packaging. The Australian Border Force has been notified to seize and destroy any such items at the border.
Botox: Use and Regulation
Botox (Botulinum toxin) is an injected medicine that temporarily relaxes muscles and blocks neurological signals that activate sweat glands or cause pain. It treats conditions such as excessive blinking, lazy eye, overactive bladders, headaches, excessive sweating, and wrinkles.
In Australia, Botox is a prescription-only medicine. Individuals with valid prescriptions can legally import products for personal use but are prohibited from importing counterfeit items.
Injections should only be administered by a doctor familiar with the required technique.
Regulatory and Health Practitioner Statements
The Australian Health Practitioner Regulation Agency (AHPRA) emphasized that:
Cosmetic injectables are prescription medicines for patient safety.
AHPRA advises seeking treatment from registered health practitioners with the necessary skill and training. Sourcing these medicines without a prescription carries risks of serious side effects, compounded by the dangers of counterfeit products.
Concerns have been raised about patients seeking cosmetic injectable services via social media, often performed by unregistered practitioners using illegal products of unknown origin.
Instances of Harm and New Guidelines
Earlier this month, a Queensland nurse was banned from practicing for at least two years after administering Botox without a doctor's consultation or valid prescription.
In January last year, Victorian and NSW regulators issued warnings after four suspected botulism cases linked to unregulated anti-wrinkle products from unlicensed premises. Botulism, caused by the bacterium Clostridium botulinum, is a rare and potentially deadly disease affecting the nervous system, potentially leading to paralysis.
In September last year, AHPRA introduced new national guidelines to enhance patient protection. These include mandatory eligibility screenings, minimum experience periods for nurses administering injectables, and advertising restrictions.
Expert Opinion on Dangers
Thomas Jeffries, a senior lecturer in microbiology at Western Sydney University, highlighted that counterfeit Botox products carry risks of mismeasurement, potentially leading to higher-than-stated doses due to carry-over of the toxin during preparation.
Thomas Jeffries stressed that Botox is a serious nerve toxin, and an excessive dose can paralyze nerves controlling heart rate.
Symptoms of botulism from improper injections include loss of nerve sensitivity, vision problems, slurred speech, dizziness, and lack of limb control. He advises individuals seeking Botox to ensure it is from a trusted, certified clinic with a good reputation.