Dilart and Dilart HCT (valsartan)

Dilart and Dilart HCT (valsartan)

Recall - potential contamination

23 November 2018

Consumers and health professionals are advised that Alphapharm (trading as Mylan Australia), in consultation with the TGA, is recalling all batches of Dilart (valsartan) and Dilart HCT (valsartan and hydrochlorothiazide) tablets in Australia due to the presence of trace amounts of an impurity.

These valsartan-containing products are used to treat high blood pressure (also known as hypertension) and other heart-related disorders.

The impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by an Indian manufacturing plant. This is a different impurity to one found in overseas valsartan products in July and August (N-nitrosodimethylamine (NDMA)) which were produced by manufacturers in China.

While these impurities are classified as probable human carcinogens (substances that could cause cancer), they are also commonly found in a variety of foods, particularly smoked and cured meats, some drinking water, in air pollution and are associated with some industrial processes.

The risk posed by the impurity at the levels found in these tablets is very low. Patients should not stop their treatment without consulting a doctor or pharmacist, as suddenly stopping high blood pressure medication poses more risk than the impurity.

Valsartan products supplied by Novartis and Apotex are unaffected by this issue:

• Valsartan tablets are supplied by Novartis (Diovan) and Apotex (APO-Valsartan)
• Valsartan and hydrochlorothiazide tablets are supplied by Novartis (Co-Diovan).

Information for consumers

If you, or a person you provide care for, is being treated with Dilart or Dilart HCT tablets, ensure they carry on taking their medication until an alternate product can be supplied. The risk posed by this impurity is very low and it is riskier for patients to suddenly stop taking high blood pressure medication.

Patients should not stop their treatment without consulting a doctor or pharmacist.

Mylan Australia has written to pharmacies and is placing advertisements in print media with instructions for consumers about the recall.

Information for health professionals

If you are treating a patient using Dilart or Dilart HCT tablets, advise them of the issue.

Mylan Australia has written to pharmacists providing further information about this issue, including details of the recall process. Pharmacists should inspect their stock and quarantine all packs before returning them to the wholesaler.

Patients returning affected packs of Dilart or Dilart HCT tablets should be provided a full refund and, if possible, offered an equivalent product to ensure continuation of therapy.

Alternative Valsartan products currently supplied by Novartis and Apotex are unaffected by this issue.

• Valsartan tablets are supplied by Novartis (Diovan) and Apotex (APO-Valsartan)
• Valsartan and hydrochlorothiazide tablets are supplied by Novartis (Co-Diovan).

If you have any further questions or concerns about this issue, please contact Mylan Australia on 1800 274 276.

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.

Valsartan

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.