Disrupted supply of Accuretic (quinapril and hydrochlorothiazide) tablets

From August 2022, supplies of Accuretic tablets will begin to be disrupted. Accuretic tablets are used to treat high blood pressure (hypertension). Lowering blood pressure reduces your risk of heart attack and stroke.

✔  When you are next due a repeat supply of Accuretic, you need to talk to your healthcare professional to get a prescription for a new high blood pressure medicine. (Pharmac is working on options to make sure there are no extra costs involved).
✔  You should keep taking Accuretic as prescribed until you have your new treatment. 

What is happening to Accuretic and why?

From August 2022, supplies of Accuretic tablets will begin to be disrupted. Recent batches of Accuretic (quinapril with hydrochlorothiazide), have been found to have small amounts of 2 contaminants, called N-nitroso-quinapril and N-nitroso-hydrochlorothiazide. These contaminants belong to a group of chemicals known as nitrosamines.

  • Nitrosamines are chemicals that are commonly found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.
  • Sometimes in the manufacturing of medicines, nitrosamine impurities can be introduced, but as part of the regulatory standards in the manufacturing process of medicines, organisations such as the FDA have set internationally-recognized acceptable daily intake limits for nitrosamines.
  • If medicines contain levels of nitrosamines above the acceptable daily intake limits, it is recommended these medicines be recalled by the manufacturer. 
The risk to anyone taking Accuretic is low 
Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. However, a person taking a medicine that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer. 

You should keep taking your Accuretic until you have spoken to a medical professional.

Supplies of Accuretic have been disrupted globally

The disruption in supply of Accuretic has affected other countries and is a global issue. Pfizer, the supplier of Accuretic, has been undertaking voluntary recalls of the medicine around the world, including in Australia, Europe, the United States of America, and Canada.

Other quinapril products are not affected
The contamination issue does not affect other quinapril products. Arrow-Quinapril is the funded brand of quinapril (without hydrochlorothiazide). There is ample stock of Arrow-Quinapril. 

What is the stock situation of Accuretic in New Zealand?

From August 2022, supplies of Accuretic will begin to be disrupted. So, if you are taking Accuretic, it is important that you see your doctor about changing to an alternative treatment when you are due to fill your repeat or get a new prescription.

Pfizer has not provided a timeframe for the availability of non-contaminated stock of quinapril with hydrochlorothiazide for the New Zealand market. They have indicated that it could be more than 12 months.

References

  1. Accuretic (quinapril and hydrochlorothiazide) tablets: Supply issue Pharmac, NZ, 29 June 2022
  2. Accuretic found to contain nitrosamines Medsafe, NZ, 30 June 2022
  3. What you should know about nitrosamine impurities Food and Drug Administration (FDA), United States