A new EU-wide warning about contaminated blood pressure medicine Valsartan does not affect Malta, the Health Ministry said.
The EU this week cracked down on Valsartan made by an India-based unit of Mylan Laboratories Limited after some batches were found to contain a probable cancer-causing impurity.
The European Directorate for the Quality of Medicines and Healthcare suspended the manufacturer’s certificate of compliance with European standards for quality testing, effectively prohibiting the use of its Valsartan in EU medicines.
Cancer-causing impurities had already been linked to batches of Valsartan earlier in the year, leading to a global recall.
European regulators said in July the drug, manufactured in bulk by a Chinese company and sold worldwide, might have contained an impurity linked to cancer since 2012.
Malta’s stock does not form part of the contaminated batch from the India-based unit of Mylan
Malta was one of 22 affected countries, with about 27,000 patients getting Valsartan through the government’s Pharmacy of Your Choice scheme.
As soon as the issue was made public, the Central Procurement Services Unit started the process to obtain uncontaminated pills, with local health experts telling patients that continuing to take the medication in the short term was less risky than stopping it abruptly.
Stopping the medication could result in a rebound surge in blood pressure with a consequent increased risk of strokes and heart attacks. Patients were first switched to Caldesartan and when uncontaminated stock became available, they started to switch back to Valsartan.
This time around, Malta’s stock does not form part of the contaminated batch from the India-based unit of Mylan.
“There are is no Valsartan imported into Malta from the contaminated source in India. Nonetheless, the Maltese authorities are closely following the situation in Europe through the European Medicines Authority,” a Health Ministry spokesman told the Times of Malta.
“Current Valsartan batches at the CPSU are from Mylan Italy (not contaminated) and Crescent Pharma UK,” he noted.