Medicine recalls
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| Australia: Quinapril: Low levels of contamination with N-nitroso-quinapril |
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The Therapeutic Goods Administration (TGA) announces that it is investigating potential contamination of quinapril medicines with very low levels of the nitrosamine impurity N-nitroso-quinapril and in quinapril medicines with hydrochlorothiazide. The TGA has been advised that very low levels of the N-nitroso-quinapril have been detected in Australian quinapril products including when quinapril has been combined with hydrochlorothiazide. This issue also affects quinapril products and quinapril with hydrochlorothiazide supplied internationally.
As a precautionary measure, the sponsor of Accupril and Accuretic/Aquinaretic, Pfizer Australia has paused supply of their quinapril products while this issue is investigated. In addition, all batches of Accupril and Accuretic/Aquinaretic tablets have been recalled from pharmacies that were identified as containing unacceptable levels of N-nitroso-quinapril. Pfizer Australia has notified the TGA of the shortage of their quinapril tablet and quinapril with hydrochlorothiazide tablet products.
Consumers are advised to continue to take their quinapril medicines as prescribed. Patients should not stop taking their quinapril medicines unless instructed to by their health professional. Health professionals should be aware that there may be limited availability of quinapril and quinapril with hydrochlorothiazide products due to the current shortage. Alternative treatment options should be considered.
N-nitroso-quinapril is a type of nitrosamine that is present as an impurity. Nitrosamines are a group of compounds which can damage DNA. They are commonly found in low levels in a variety of foods, including smoked and cured meats, dairy products, vegetables, in some drinking water, and in air pollution. Long-term exposure, over years, can increase an individual's risk of developing cancer. The additional risk that would be posed by the trace levels of N-nitroso-quinapril being detected in quinapril products is likely to be very low. However, the presence of nitrosamine impurities is generally considered unacceptable for a medicine. The actual health risk depends on the medicine and dose taken and will vary from person to person.
The TGA is working with quinapril medicine sponsors to further investigate this issue and determine what actions may be required.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/quinapril
In Hong Kong, there is no registered pharmaceutical product containing quinapril. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 4 Mar 2022, with the latest update posted on 6 May 2022.
Ends/Thursday, Aug 18, 2022
Issued at HKT 15:00
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