Gold Cross Liquid Paraffin (iNova Pharmaceuticals (Australia) Pty Ltd)
Product Name
Gold Cross Liquid Paraffin
Date of review outcome
Date of publication
Sep-21
Outcome
Medicine continues to be permitted for supply. Batches released from May 2021 must carry a corrected label containing the required warning statement for constipation.
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?
Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding, seek the advice of a healthcare professional before taking this medicine.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The label for the medicine was missing the mandatory warning statement 'Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding, seek the advice of a healthcare professional before taking this product'. As such, consumers may not be alerted to these safety risks prior to taking the medicine.
While this is unacceptable, the label warns consumers 'If symptoms persist consult your healthcare practitioner', 'Drink plenty of water' and 'Prolonged use may cause serious bowel problems'. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
While this is unacceptable, the label warns consumers 'If symptoms persist consult your healthcare practitioner', 'Drink plenty of water' and 'Prolonged use may cause serious bowel problems'. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label to include the required warning statements.