Difflam Throat Defence Probiotic (iNova Pharmaceuticals (Australia) Pty Ltd)
Product Name
Difflam Throat Defence Probiotic
ARTG
311790
Date of review outcome
Date of publication
Sep-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, however, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
The medicine contains sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to sulfites. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to restoring and increasing good bacteria in the mouth and throat, and fighting winter illnesses.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to restoring and increasing good bacteria in the mouth and throat, and fighting winter illnesses.
Review scope
Random
Information reviewed
ARTG Record, Labels
Issues related to safety
The label did not include the mandatory declaration for ‘sulfites’. Sulfites are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. Whilst the undeclared presence of trace amounts of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to trace residue of sulfites (such as anaphylaxis) are rare. In addition, supply of the medicine ceased in June 2021 and no stock remains on the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label claimed that the medicine may ‘restore and increase good bacteria in the mouth and throat and fight winter illnesses’. However, these claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.