The local health authorities are sourcing alternative sources of uncontaminated valsartan, after a recall of the blood pressure drug from 22 countries, including Malta.
According to the European Medicines Agency, the drug was recently found to contain a chemical that poses a potential cancer risk.
The problem was discovered during tests of batches of Valsartan's active pharmaceutical ingredient, as those from an external supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China, contained an impurity.
The agency said the impurity is "a result of a change in the manufacturing process".
The Medicines Auhtority in Malta said that as a precaution, patients should seek guidance from thier doctor or pharmacist – but that they should not stop taking their valsartan until an alternative is available, as doing so could cause serious health problems.
Valsartan is used to control blood pressure and help prevent heart failure. Its patent expired in 2012 and it is now used as a component of other generic medicines.
The recall involves about 2,300 batches that were sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta, according to CNN.
EMA's information for patients
• An unexpected impurity has been found in the active ingredient used to make some valsartan medicines.
• Only some valsartan medicines in the EU are affected and these are being recalled.
• You should not stop taking your valsartan medicine unless you have been told to do so by your doctor or pharmacist.
• You may be given a different valsartan medicine (or an alternative treatment) when you go for your next prescription.
• If you have any questions about your treatment, speak to your pharmacist who can tell you if your medicine is being recalled.
• If you are in a clinical trial with valsartan and have any questions, speak to the doctor treating you in the trial.
• EMA will assess whether the impurity may pose any risk for patients. Further information will be provided once available.
Information for healthcare professionals
• N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals.
• As a result, valsartan medicines containing the active substance from Zhejiang Huahai are being recalled in the EU.