Safety Advisory – Medicines containing Eucommia ulmoides
The Therapeutic Goods Administration (TGA) issued a safety advisory warning on 13 January 2021 for listed medicines containing Eucommia ulmoides, also known as Du Zhong and Tu Chung.
The TGA has recently become aware that Eucommia ulmoides contains naturally occurring latex and, as such, listed medicines containing Eucommia ulmoides may pose a risk for individuals with a latex allergy or sensitivity. As the latex used in commercial rubber products is obtained from a different plant, the TGA is investigating the extent to which people with a latex allergy will react to the naturally occurring latex in Eucommia ulmoides. While there is currently no requirement for a label warning to declare the presence of latex, the introduction of one is being considered. For the moment the TGA is advising individuals with a latex allergy to avoid Eucommia ulmoides given the potential for an allergic reaction.
Sponsors
Although it is not currently required, to ensure that you meet your responsibilities as a sponsor, i.e. that your products are safe for use, we recommend that until further advice is provided by the TGA, sponsors add the label declaration “Contains naturally occurring latex” to any future batches of product containing Eucommia ulmoides. This could also avoid potential stop-supply issues for your products containing Eucommia ulmoides that may result from the above TGA investigation.
A Chinese translation of the Eucommia Safety Advisory is also available.
Pharmacovigilance Obligations
Sponsors are also reminded of their pharmacovigilance (PV) obligations which include logging safety alerts and reporting all serious adverse events to the TGA within required timeframes. To date the TGA has received one report of an allergic reaction associated with a listed medicine that contained Eucommia ulmoides along with several other ingredients.
In January, the TGA published a Frequently asked questions tool in relation to the PV obligations of medicine sponsors. This provides a quick reference guide, however, to ensure full compliance with PV requirements, the FAQ’s should be used in conjunction with a thorough knowledge of the Pharmacovigilance Guidelines (Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements). This guidance outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practice.
For advice or assistance relating to your pharmacovigilance obligations contact us. We can also provide our in-house developed Pharmacovigilance System with training to provide the optimal process for fulfilling your obligations.
