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There does not appear to be any evidence which demonstrates that any of the following probiotic organisms are effective for vaginal conditions when taken orally:
- Lactobacillus rhamnosus
- Saccharomyces cerevisiae (Boulardii)
- Lactobacillus acidophilus.
If you are currently taking oral probiotics with the above organisms, please be aware there are no immediate concerns regarding the safety and quality of listed oral probiotics. However, if you have a serious medical condition, seek professional medical advice.
Background
The TGA has undertaken compliance review activities relating to the probiotic species mentioned above. We have identified potential concerns regarding the evidence to support the oral intake of these species indicated for vaginal conditions (vulvovaginitis, bacterial vaginosis, vaginal candida or yeast infections).
We conducted a search of the publicly available literature. Twenty-six papers were considered relevant and evaluated. Issues with the studies included:
- Poor study methods (e.g. sample size too small, high dropout rate, lack of compliance controls, results that were not statistically significant).
- Inadequate reporting and presentation of the study results did not allow for independent assessment of the results.
- The dosage form of the probiotics in the studies was not comparable to commercially available probiotics (i.e. tablets or capsules).
What sponsors of existing listed medicines need to do
Sponsors of listed medicines containing the above species indicated for vaginal conditions are encouraged to:
- re-evaluate the evidence they currently hold; and
- reconsider the indications made for their products.
You can make changes to the listing of an affected medicine via TGA Business Services. Please refer to the Listed medicines application and submission user guide for guidance on this process.
- Any changes to your medicine's ARTG entry must also be reflected on the medicine's label and any advertising material.
What the TGA will do
- We wrote to sponsors to let them know that we would be undertaking compliance reviews on particular probiotics listed on the ARTG
- We specifically focussed on oral probiotics that contained the species Lactobacillus rhamnosus, Saccharomyces cerevisiae (Boulardii) and/or Lactobacillus acidophilus with indications relating to the treatment of vaginal conditions.
- 23 probiotics that fit the criteria above were identified on the ARTG
- We performed compliance reviews on all of these products
- 12 of these probiotics removed all the indications associated with treatment of vaginal conditions and remain on the ARTG
- 9 probiotics were cancelled from the ARTG by the sponsor
- 2 probiotics were cancelled from the ARTG by the TGA