Listed medicines containing Valeriana officinalis requiring warning statements

We will be initiating targeted compliance reviews of selected listed medicines that require a warning statement because the medicine contains Valeriana officinalis as an active ingredient. The 3 ingredients that are subject to the warning statement are:

• Valeriana officinalis;
• Valerian powder;
• Valerian dry.

If you are a consumer, please note that this is part of our normal review process and there is no immediate concern associated with the use of these types of listed medicines.

Background

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. Although these ingredients are considered low risk to the general adult population, some consumers may experience potential unwanted side effects. One tool that we use to ensure the safety of listed medicines is by requiring sponsors to add warning statements on medicine labels. Medicines that contain Valeriana officinalis as an active ingredient are required to display the following warning statement:

• 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

The absence of the required warning statement in medicines that contain Valeriana officinalis may result in consumers not being able to identify symptoms of early-stage liver injury and not take early actions to minimise further liver damage.

We will be selecting listed medicines that contain the above ingredients for compliance review to ensure that they display the required warning statement.

What sponsors should do

The Therapeutic Goods (Permissible Ingredients) Determination contains the list of ingredients allowed by the TGA for use in listed medicines and any specific requirements (such as warning statements) for each ingredient.

If you are a sponsor of a listed medicine that contains Valeriana officinalis, you are encouraged to:

• re-evaluate the presentation of the goods including the medicine label, particularly for the warning statement required for your medicine.

If your medicine is selected for review, you will receive a Request for Information notice. This notice will contain an explanation of the review process, outline the information you are required to submit and relevant due dates for your response.

If you decide to cancel the listing of your medicine in response to the Request for Information notice, we may still request certain documentation to be provided to ensure that the certifications made at the time of listing were correct.

What TGA will do

The TGA will commence desktop compliance reviews for a selection of listed medicines that contain Valeriana officinalis and therefore require a warning statement in early 2025. These may either be selected randomly or on the basis of regulatory intelligence.

We will send sponsors of these medicines a Request for Information notice informing them of the commencement of the review and outlining the information sponsors are required to submit. Upon receipt of the information provided by sponsors, we will assess the medicine against listing requirements, with particular focus on the required warning statement.

If no compliance deficiencies are identified for a selected medicine, the review will be concluded and there will be no further regulatory action. If deficiencies are identified, the sponsor will be given an opportunity to address the deficiencies. Additionally, enforcement actions (such as recall, cancellation of the medicine from the ARTG, issuing of infringement notices, etc.) may be taken.

A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.