Fertility Formula Female (Mygen Health Pty Ltd)
Product Name
Fertility Formula Female
Sponsor
ARTG
301937
Date of review outcome
Date of publication
Dec-19
Outcome
Medicine continues to be permitted for supply. Batches released from February 2020 must carry a correct vitamin B6 warning statement on the medicine label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended action for consumers below
What action should consumers take?
Stop taking this medicine if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible, especially if you are taking multiple medicines containing vitamin B6.
Review scope
Targeted
Information reviewed
Labels
Issues related to safety
The label had an incorrect version of the warning statement ‘Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]’, in that the statement ‘Contains vitamin B6’ was missing. These symptoms may be signs of nerve damage in some individuals as a result of vitamin B6 intake. It is important to help consumers link these symptoms to medicines containing vitamin B6, especially when taking medicines with multiple ingredients.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the product. The sponsor updated the label to include the correct warning statement.