Uncontaminated valsartan or a suitable substitute to the blood-pressure drug will be available in pharmacies this week, the Times of Malta has been informed.
Patients who consume the drug have been advised to contact their doctor after the European Medicines Agency raised the alarm over a key ingredient found to contain an impurity – a chemical that could pose a potential cancer risk.
Some 27,000 patients in Malta take valsartan through the government’s Pharmacy of Your Choice scheme, and local health experts have warned that continuing to take the medication in the short term is less risky than stopping it abruptly.
Cardiologist Robert Xuereb explained that patients should not stop taking their medication abruptly, since it would result in a rebound surge in blood pressure with a consequent increased risk of strokes and heart attacks.
Patients should not stop taking their medication abruptly
When contacted, a spokeswoman for the Health Ministry said that as soon as the issue of valsartan was made public internationally, the Central Procurement Services Unit started the process to obtain uncontaminated pills or a suitable substitute. The said stock will be available in pharmacies later this week, she added.
According to the latest reports, European regulators have said the drug, manufactured in bulk by a Chinese company and sold worldwide, may have contained an impurity linked to cancer since 2012.
The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could have been exposed to cancer risk.
EMA said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.
Mr Xuereb said NDMA was used to make liquid rocket fuel, softeners and lubricants and could be a by-product of pesticide and rubber tyre manufacturing.
It was identified during routine batch testing of valsartan supplied by Zhejiang Huahai in Linhai resulting from a change in its manufacturing process.
EU authorities have, meanwhile, been recalling medicines containing valsartan from Zhejiang Huahai over the past two weeks, and the EMA said they should no longer be available in pharmacies.
The US Food and Drug Administration also took action to recall affected medicines containing valsartan on Friday.