Safety advisory - products in Australia not affected by overseas recalls

8 August 2018

Consumers and health professionals are advised that valsartan-containing medicines, used to treat high blood pressure (also known as hypertension), are not currently subject to any recall action in Australia.

The TGA is aware of overseas recall actions for certain valsartan-containing medicines due to a risk of contamination. Products manufactured using the valsartan active ingredient sourced from three Chinese manufacturers may be contaminated with an impurity that is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

These Chinese manufacturing sites have not supplied the valsartan active ingredient used in any medicines supplied in Australia. No other active ingredients manufactured at these sites are affected by this issue.

The TGA has been in contact with the four companies that sponsor products containing valsartan on the Australian Register of Therapeutic Goods. The TGA contacted these companies when the overseas issue was first identified some time ago and additional verification was obtained this week to reconfirm that no affected stock has been supplied in Australia.

There is no identified risk to public health and safety for Australian patients.

Information for consumers

While some media headlines and articles regarding the overseas recall actions may have caused concern for Australian consumers, no medicines supplied in Australia are affected by this issue.

Patients in Australia can safely continue to take products containing valsartan as prescribed by their doctor.

If you have any further questions or concerns, talk to your prescribing doctor.

Information for health professionals

If you are treating patients who take valsartan-containing medicines, please advise them accordingly.

Reassure them that no such products supplied in Australia have been contaminated with the identified impurity. Advise them to continue taking their medicine as prescribed.

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.