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| Australia: Quinapril blood pressure medicines: Safety advisory – low levels of contamination with N-nitroso-quinapril (English only) |
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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 all quinapril products supplied in Australia, 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 sponsors of all marketed quinapril tablet products and quinapril with hydrochlorothiazide products have paused supply of these medicines while this issue is investigated. In addition, all batches of quinapril tablets and quinapril with hydrochlorothiazide tablets that were identified as containing unacceptable levels of N-nitroso-quinapril have been recalled from pharmacies.
Pfizer Australia has notified the TGA of the shortage of their quinapril tablet and quinapril with hydrochlorothiazide tablet products. Generic Health and Arrotex Pharmaceuticals have also notified the TGA of shortages for their quinapril tablet products.
Consumers are advised to continue to take their quinapril medicines as prescribed. Quinapril products will not be available while there is a shortage due to recalls. Patients should speak to their doctor regarding alternative treatment options. Patients should not stop taking their quinapril medicines unless instructed to by their doctor.
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. The TGA has reviewed results reported by sponsors of quinapril and quinapril with hydrochlorothiazide medicines on the Australian Register of Therapeutic Goods. Sponsors of affected medicines are taking corrective action to introduce impurity control measures to ensure that only batches of quinapril that comply with internationally acceptable intake limits are released. The TGA and other international regulators will continue to monitor medicines to ensure that they meet appropriate quality standards.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/quinapril-blood-pressure-medicines
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 26 Oct 2022.
Ends/Friday, Dec 9, 2022
Issued at HKT 15:00
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