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Sartan blood pressure medicines

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TGA investigation - potential contamination with N-nitroso compounds

26 February 2019

Update - 15 September 2019

The TGA has issued information for sponsors of sartan medicine to advise that requirements are being introduced to ensure that sartan medicines do not contain N-nitroso compounds - see Information for sponsors.

Consumers and health professionals are advised that the TGA is investigating the potential contamination of 'sartan' blood pressure medicines.

Angiotensin receptor blockers are a class of medicines that is used to treat high blood pressure (also known as hypertension). These medicines have names that end in 'sartan', including valsartan, irbesartan, candesartan, losartan and olmesartan.

Internationally, a number of these medicines have been identified as having unacceptable levels of impurities - specifically N-nitroso compounds.

The issue was first identified in July 2018 in valsartan-containing medicines that were manufactured using an active pharmaceutical ingredient (API) sourced from a Chinese API manufacturer. These products were recalled in some overseas countries, but TGA investigations found that no valsartan products being supplied in Australia used API from this manufacturer.

Later, it was identified that other sartan APIs from the Chinese API manufacturer, and also sartan APIs sourced from other manufacturers, were also affected. Some products supplied in Australia used APIs from these sources. As of 30 January 2019, four products supplied in Australia have been recalled as a result of this safety concern (see 'Recall actions' below).

What are N-nitroso compounds?

N-nitroso compounds are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as 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 posed by N-nitroso compounds in sartan medicines, at the concentrations identified to date, is considered to be very low. However, such contamination is considered unacceptable for a medicine. The actual health risks depend on dose and will vary from person to person.

What should consumers do?

Patients who take 'sartan' medicines - even if they are affected by this safety issue - should not stop their treatment without first consulting a doctor or pharmacist. As the risks are associated with long term exposure, there is no immediate health risk.

Consumers should be aware that not all 'sartan' medications are affected. It is also important to note that even when there is a problem with a product, not all batches may be affected.

Suddenly stopping blood pressure medicines can pose a greater and more immediate risk to health than potential contamination with N-nitroso compounds.

What is the TGA doing?

The TGA is working with international regulators and medicine sponsors to investigate and resolve this issue. The TGA is also undertaking testing of Australian 'sartan' medications to determine if any further batches are affected.

The effect of this issue on medicine shortages is also being closely monitored.

The TGA will publish updated information as it becomes available. In the meantime, if consumers have any questions or concerns about this issue, they should speak to their health professional. Information for health professionals is provided in the individual recall notices for affected products.

Recall actions

There have been two safety advisories published on the TGA website for consumer-level recalls of valsartan containing products relating to this issue:

Two retail-level recalls have also been undertaken:

  • Sandoz Irbesartan/HCT 300/12.5 mg (three batches) - December 2018
  • Sandoz Irbesartan 150 mg (one batch) - January 2019.

Details of all of the above recalls appear in the TGA's System for Australian Recall Actions database.

Reporting problems

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.