Meanwhile, MOHAP also explained that other medicines containing Valsartan, which are manufactured using the same active ingredient from other sources, are intact and unaffected-meaning that these are still safe to use.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall yesterday (July 10) of all batches of valsartan/hydrochlorothiazide 160/12.5mg film-coated tablets - used to treat high blood pressure and heart conditions - made by Accord Healthcare.
The European Medicines Agency believes NDMA entered the hypertension drugs as a result of Zhejiang Huhai changing its production process.
The next step for the EMA is to conduct a review of the situation, including determining the levels of NDMA in the products, understanding how this may have affected patients and planning methods to eliminate or reduce such contamination in the future.
As it is now off-patent, it is used as ingredient in many other generic medicines. The company says that "no other Sandoz or Novartis products, even those that may contain valsartan, are affected by the recall". For example, Swiss company Novartis informed the ministry that their products containing valsartan are not impacted because these products do not contain the ingredient from external suppliers.
Health Canada also advises anyone taking any medication containing valsartan to speak to their pharmacist to find out if their medicine is being recalled.
In addition, the Ministry of Health and Welfare is looking for ways to inform patients of their pharmaceutical history through the Drug Utilization Review software and said it has already granted full health insurance coverage for patients who were taking the contaminated drugs and need alternatives.
The drugs, made with the active ingredient valsartan, were found to contain N-nitrosodimethylamine (NDMA), a chemical that's been classified as a probable human carcinogen by the International Agency for Research on Cancer.