A Chinese translation 中文翻译 of this information is available below.
The Therapeutic Goods Administration (TGA) is warning consumers and health professionals that listed medicines containing the herbal ingredient Eucommia ulmoides may pose a risk for individuals with a latex allergy or sensitivity.
Eucommia ulmoides (also known as Du-Zhong or Tu-chung) is permitted for use in listed medicines in Australia. The TGA has recently become aware that the Eucommia ulmoides plant which makes up the herbal ingredient contains naturally occurring latex. It is not currently required that the presence of latex be declared on medicine labels. Exposure to latex can cause severe and sometimes life-threatening reactions in individuals with a latex allergy and should be avoided, particularly exposure to the mouth. Allergic reactions to latex can vary and include immediate reactions, including anaphylaxis when severe, as well as irritant dermatitis and allergic contact dermatitis. All types require avoidance of contact with latex to prevent an allergic reaction.
Listed medicines that contain Eucommia ulmoides are available from a range of suppliers, including through health food stores and Traditional Chinese Medicine (TCM) practitioners. Eucommia ulmoides has been traditionally used for a variety of conditions, including for purported anti-inflammatory effects and relief of minor arthritic conditions.
The latex that is commonly used in commercial rubber products is obtained from a different plant, and the extent to which people with a latex allergy will react to latex in Eucommia ulmoides is still under investigation. As part of this investigation, the TGA is considering whether a label statement is needed to declare the presence of latex in listed medicines that contain Eucommia ulmoides. In the meantime, the TGA considers it prudent for individuals with a latex allergy to avoid Eucommia ulmoides given the potential for an allergic reaction. 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.
Information for consumers
If you have a latex allergy or sensitivity you should avoid medicines that contain Eucommia ulmoides.
If you have any concerns or questions about this issue, speak to your health professional.
Information for health professionals
Please be aware that products containing Eucommia ulmoides may pose a risk in individuals with latex allergy or sensitivity. Advise patients who are allergic to latex not to take products containing Eucommia ulmoides.
Information for sponsors
Sponsors are reminded of their obligation to comply with the requirement that listed medicines must be safe for their intended purpose. Sponsors are expected to address any identified safety concerns for their product(s), even if product(s) are compliant with other requirements. Failure to do so could lead to regulatory action, which may include the recall and/or cancellation of a product.
Sponsors are also reminded of their obligation to report all serious adverse events to the TGA within required timeframes.
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.
The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
含有杜仲的药品 (学名Eucommia ulmoides）
澳大利元允许在列药品使用杜仲（Eucommia ulmoides）。治疗产品管理局近期注意到药用植物杜仲含有天然乳胶。目前不要求在药品标签上声明存在乳胶。乳胶可对过敏者导致严重，有时危及生命的反应。有过敏反应者应避免接触乳胶，尤其是口腔接触。对乳胶的过敏反应可有不同类型，包括即时反应-严重时可有过敏性休克， 及激惹性皮炎和过敏性接触性皮炎。所有类型都要求避免接触乳胶以防过敏反应。
常用于橡胶制品中的乳胶是从一种不同的植物中获取的。乳胶过敏者对存在于杜仲（Eucommia ulmoides）中的乳胶的反应程度仍在调查中。作为该调查的一部分，治疗产品管理局正在考虑是否需要含杜仲的在列药品在标签上声明含有乳胶。同时，由于过敏反应的可能性，治疗产品管理局出于慎重起见，认为对乳胶过敏人士应避免接触杜仲。 迄今为止我局已接到一例与含杜仲和其他几种成分的在列药品有关的过敏反应报告。
提醒厂商有义务遵守 在列药品必须符合安全达到其预期目的之要求。厂商对其产品的任何安全疑虑一经发现，应着手解决，即使产品符合其他要求。 违反要求将导致可能包括召回产品和/或取消产品注册资格的监管行动。