Listed medicines requiring a pregnancy warning statement

In 2022, we initiated targeted compliance reviews for listed medicines that required pregnancy warning statements on the label based on their inclusion of either of the ingredients Azadirachta indica or Piper methysticum.

What led to this review?

Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements. Listed medicines are only permitted to contain low risk ingredients from a pre-approved list at certain quantities. This list of approved ingredients can be found within the Therapeutic Goods (Permissible Ingredients) Determination. Although these ingredients are considered low risk to the general adult population, some may still pose a risk during pregnancy.

One tool that we use to ensure the safety of listed medicines for specific population groups, such as pregnant women, is by using warning statements on the medicine label and any other advertising materials. There are over 80 ingredients approved for use in listed medicines which may require a warning statement about pregnancy.

The absence of these warning statements for medicines that contain these ingredients may result in accidental use during pregnancy resulting in the increased possibility of adverse events. Selected products containing either of the two ingredients Azadirachta indica or Piper methysticum were included in this targeted project.

What did we do?

We identified 20 listed medicines that contained either Azadirachta indica or Piper methysticum that required the inclusion of pregnancy warning statements on the respective labels. We asked the sponsors of these medicines to provide the in-use labels to review for the required pregnancy warning statement.

What did we find?

The sponsors of 20 medicines (100%) responded to our request for information:

• 17 medicines were found to include the required warning statement on the in-use labels;
• 1 medicine was found to be missing the required warning statement on the in-use label and was cancelled from the ARTG by the sponsor;
• 2 were cancelled from the ARTG by the sponsors;
• 7 medicines were identified to have non-compliances outside the scope of this project. The sponsors were informed of these findings and expected to rectify these issues.

The compliance review results for each medicine are published on the page Listed medicine compliance reports.

Information for sponsors

If you are the sponsor of one or more listed medicines, you should review the ingredients used in your medicine/s to ensure that:

• any requirements and warning statements listed in the Therapeutic Goods (Permissible Ingredients) Determination are adhered to with respect to your medicine;
• the presentation of your medicine, including web advertising and any related social media, also meet any requirements related to ingredients specified in the Therapeutic Goods (Permissible Ingredients) Determination.