Sinusitis (McPherson's Consumer Products Pty Ltd)
Product Name
Sinusitis
ARTG
269953
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given the claims about its traditional use in Chinese Medicine for the relief of sinusitis symptoms/nasal congestion/rhinorrhoea/allergic rhinitis (hay fever)/catarrh/nasal mucosal irritation or inflammation, sinus pain/pressure, headache, low grade fever, anti-infective, antibacterial and antiviral properties, to dispel/disperse wind, wind-damp, release the exterior, expel wind-heat and wind-cold, dislodge phlegm, open the orifices, clear lung heat and damp heat and toxins from spleen and stomach and use in children under 18 years of age were not substantiated by the sponsor. Seek advice from a suitably qualified health professional if you have been taking this medicine for chronic sinusitis.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label and website of the medicine implied it can relieve chronic sinusitis, which is a serious condition that requires diagnosis, treatment or supervision by a suitably qualified healthcare professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to chronic sinusitis has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label also warns consumers to see a health professional if symptoms persist. In addition, supply of the medicine stopped in June 2021 and it is unlikely any stock remains on the market. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the advertised claims detailed in ‘What action should consumers take?’ above. The dosages, method of preparation of ingredients and plant species/subspecies/part in the evidence provided were not relevant to the medicine. The populations described in the evidence were not relevant to a target population (children) of the medicine.
Actions taken during the review
The sponsor updated their label and website to remove references to chronic sinusitis and use in children. The TGA issued an educational letter to the sponsor, who was expected to correct the identified issues but was not required to respond. The sponsor responded with additional information. During the review, sponsorship of the medicine changed to McPherson's Consumer Products Pty Ltd, who cancelled the medicine and withdrew it from further supply.