Perdays Pregnancy Iron & Vitamin C (PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD)
Product Name
Perdays Pregnancy Iron & Vitamin C
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 the treatment and/or prevention of postpartum depression.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for prevention of iron deficiency, support of energy levels and/or support of blood health.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for prevention of iron deficiency, support of energy levels and/or support of blood health.
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 this medicine is effective in the treatment and/or the prevention of postpartum depression, support of energy levels and blood health when dietary iron intake is inadequate in pregnant women, and implied that iron supplementation is required during pregnancy. Additionally, the website for this medicine also contained claims that this medicine has no side effects. The above claims are not permitted for listed medicines. In particular, the claims relating to postpartum depression and iron supplementation during pregnancy 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 advised that pregnant women should advise their doctor of any medicine taken, particularly in their first trimester. As such, this medicine is unlikely to pose an immediate 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 advised that pregnant women should advise their doctor of any medicine taken, particularly in their first trimester. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The ARTG record, label, and website for this medicine contained claims specified in 'What action should consumers take?' above. 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, labels, and website to correct these issues.