Perdays Pregnancy Probiotic 360° & Vitamin D (PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD)
Product Name
Perdays Pregnancy Probiotic 360° & Vitamin D
Date of review outcome
Date of publication
Jun-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Stop taking this medicine immediately and seek advice from a health practitioner if you have been taking this medicine for treatment and/or prevention of depression, anxiety, or gestational diabetes.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for maintaining healthy blood sugar, controlling your glucose, supporting emotional balance and/or preventing/reducing constipation.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for maintaining healthy blood sugar, controlling your glucose, supporting emotional balance and/or preventing/reducing constipation.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The ARTG record, label or website for this medicine contained claims suggesting that it is effective in the prevention of gestational diabetes, anxiety and depression, support of healthy blood sugar, emotional balance and healthy vaginal microflora in pregnant women, and helping reduce the occurrence of eczema/dermatitis in children under 2 years. Additionally, the website for this medicine also contained claims that this medicine was safe or without harm. The above claims are not permitted for listed medicines. In particular, the claims relating to depression, anxiety and gestational diabetes have the potential to lead consumers to delay access to timely medical advice or treatment when required, and may result in adverse outcomes.
However, this medicine was not recalled as the sponsor removed these claims from the ARTG record, label, and website, and ceased supply of non-compliant stock. The label also advises 'if symptoms persist, talk to your health professional' and 'if you are concerned about the health of yourself or your baby talk to your health practitioner'. As such, this medicine is unlikely to pose a significant risk to consumer health and safety.
However, this medicine was not recalled as the sponsor removed these claims from the ARTG record, label, and website, and ceased supply of non-compliant stock. The label also advises 'if symptoms persist, talk to your health professional' and 'if you are concerned about the health of yourself or your baby talk to your health practitioner'. As such, this medicine is unlikely to pose a significant risk to consumer health and safety.
Issues related to efficacy
The ARTG record, label, and website for this medicine made claims detailed in 'What action should consumers take?' above, as well as supporting and boosting immunity. 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 this medicine. The sponsor updated the ARTG record, label, and website to correct these issues.