The Prenatal (Kin Fertility)
Product Name
The Prenatal
Sponsor
ARTG
340223
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine is no longer permitted to be supplied
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?
Seek advice from a doctor if you have been taking this medicine to reduce the risk of bleeding or blood clots, anaemia, neural tube defects, birth defects, low birth weight, and premature birth.
Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.
If you are pregnant, seek advice from a suitably qualified health professional if you have been using or intend to use this medicine for promoting thyroid function and hormones; promoting gene expression; supporting foetal cognitive, nervous system and bone development; regulating blood pressure; promoting DNA synthesis; assisting healthy red blood cell production and promoting blood health; promoting brain function; controlling memory, mood, muscle control and nervous system functions; boosting liver function; metabolising carbohydrates, fats, and proteins; reducing nausea (morning sickness), or for maintaining energy levels and production, maintaining bone health and development, maintaining immune and nervous system health, and aiding oxygen transport to body tissues.
Be aware this medicine is not a substitute for good nutrition or superior to dietary nutrition.
Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.
If you are pregnant, seek advice from a suitably qualified health professional if you have been using or intend to use this medicine for promoting thyroid function and hormones; promoting gene expression; supporting foetal cognitive, nervous system and bone development; regulating blood pressure; promoting DNA synthesis; assisting healthy red blood cell production and promoting blood health; promoting brain function; controlling memory, mood, muscle control and nervous system functions; boosting liver function; metabolising carbohydrates, fats, and proteins; reducing nausea (morning sickness), or for maintaining energy levels and production, maintaining bone health and development, maintaining immune and nervous system health, and aiding oxygen transport to body tissues.
Be aware this medicine is not a substitute for good nutrition or superior to dietary nutrition.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The ARTG record, label, social media, and website for this medicine contained claims specified in 'What action should consumers take?' above. These claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
The social media and website contained claims that this medicine was a substitute for good nutrition and superior to dietary nutrients. Vitamin or mineral supplements are prohibited from making this claim unless permission has been given by the TGA.
The social media and website contained claims that use of this medicine has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes.
The social media and website also contained claims that other prenatal/pregnancy supplements are harmful and ineffectual. All therapeutic goods supplied in Australia must be both safe and efficacious. Negative comparisons to other medicines are misleading and have the potential to discourage consumers from making appropriate decisions about self-selected medicines.
The website was missing the mandatory warning statement set out in 'What action should consumers take?'. As such, consumers may not be alerted to this safety risk prior to purchasing this medicine.
While advertising of this nature is unacceptable, the label directed consumers to advise their doctor of any medicines they take during pregnancy. In addition, the claims have been removed from the label, website, and social media. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The social media and website contained claims that this medicine was a substitute for good nutrition and superior to dietary nutrients. Vitamin or mineral supplements are prohibited from making this claim unless permission has been given by the TGA.
The social media and website contained claims that use of this medicine has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes.
The social media and website also contained claims that other prenatal/pregnancy supplements are harmful and ineffectual. All therapeutic goods supplied in Australia must be both safe and efficacious. Negative comparisons to other medicines are misleading and have the potential to discourage consumers from making appropriate decisions about self-selected medicines.
The website was missing the mandatory warning statement set out in 'What action should consumers take?'. As such, consumers may not be alerted to this safety risk prior to purchasing this medicine.
While advertising of this nature is unacceptable, the label directed consumers to advise their doctor of any medicines they take during pregnancy. In addition, the claims have been removed from the label, website, and social media. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The ARTG record, label, social media, 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 label, social media and website to correct the issues. The sponsor cancelled this medicine and withdrew it from further supply.