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Hair Tonic and Hairpro capsules
Recall - risk of liver injury
Consumers and health professionals are advised that Global Therapeutics, following a safety investigation by the TGA, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury.
The recalled products all contain the same ingredients, including the herb Fallopia multiflora. The TGA previously published a safety advisory on 29 April 2019 regarding the potential for liver injury in people who consume products containing Fallopia multiflora.
The TGA has received 15 reports of liver-related adverse events since 2014 associated with Fusion Hair Tonic and Oriental Botanicals Hairpro, including six cases with markers of severe liver injury. The liver injuries led to hospitalisation in three cases. To date, all cases reported in Australia have either improved or resolved after discontinuation of the product. While the risk of drug-induced liver injury is low, it has the potential to be life-threatening.
The products being recalled are:
- Hair Tonic (AUST L: 300605)
- Hair Tonic - Fusion Health Capsules (AUST L: 183418)
- Hairpro (AUST L: 300621)
- Hairpro - Alopecia, Hair Loss, Premature Greying – Oriental Botanicals capsules (AUST L: 189993).
Information for consumers
Consumers who have any of the affected products should stop taking them immediately and return them to the place of purchase for a refund.
Drug-induced liver injury has the potential to be life threatening. While the likelihood of liver damage is rare, consumers should seek urgent medical advice if they experience any of the following symptoms: yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain and/or loss of appetite.
Consumers are advised to discuss any concerns or questions about this issue with their health professional.
For further information contact Global Therapeutics by phone on 1800 550 103 or email firstname.lastname@example.org.
Information for health professionals
Health professionals should be aware that, in rare circumstances, these products may cause liver injury in some individuals and you should provide clinical advice accordingly.
Cases of drug-induced liver injury have been associated with Fallopia multiflora, with reports including raised liver enzymes, elevated bilirubin and/or visible jaundice. In most of the cases reported to the TGA, the onset of liver injury occurred within two months of commencing the medicine.
For more information about the recall process contact the Global Therapeutics Customer Service Line on 1800 550 103 or email email@example.com.
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.