Accuretic (quinapril 10mg + hydrochlorothiazide 12.5mg and quinapril 20mg + hydrochlorothiazide 12.5mg) is indicated in New Zealand for the treatment of hypertension in patients not adequately controlled with monotherapy.
Pfizer test results have identified the levels of N-nitroso-quinapril exceed the acceptable daily intake (ADI) level in their Accuretic products. This is a global issue, with voluntary recalls happening in other countries, including in Australia, Europe, the US, and Canada. Medsafe has issued a safety alert and Pharmac has advised prescribers to stop prescribing Accuretic and to urgently switch patients currently taking Accuretic to alternative options.
In New Zealand, there are 35,077 people taking Accuretic: 23,825 patients taking Accuretic (20mg + 12.5mg) and 11,252 taking Accuretic (10mg + 12.5mg). Almost all practices in New Zealand (98 per cent) have at least one enrolled patient taking Accuretic.
N-Nitroso-quinapril is a nitrosamine. Nitrosamines can be found in water and foods, including cured and grilled meats, dairy products and vegetables and are classified as probable human carcinogens (substances that could cause cancer). Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
For this reason, Pharmac is advising prescribers to:
- Not start any new patients on Accuretic.
- Urgently switch patients currently taking Accuretic to an alternative ACE inhibitor/angiotensin II receptor blocker (ACEi/ARB) or an alternative blood pressure-lowering medicine.
Current supplies of Accuretic will begin to be disrupted from August 2022, therefore this switch is required as soon as possible. Once supplies of Accuretic are exhausted, it is unlikely to be available again for at least 12 months. People currently taking Accuretic must continue taking it until an alternative has been prescribed, as the risk of suddenly stopping medication for blood pressure is higher than the potential risk presented by the impurity.