The recall of batches of Valsartan medicine used to control blood pressure was issued by the European Medicine Agency following detection of N-nitrosodimethylamine (NDMA), in the Valsartan active substance manufactured and supplied by Zhejiang Huahai Pharmaceuticals, China. The agency will review to ascertain the levels of NDMA in these Valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
Patients and prescribers have been asking the Drug Regulatory Authority of Pakistan (DRAP) whether Valsartan medicine manufactured by Pakistani companies produces cancer or is banned or they should stop taking this medicine.
The authority taking notice of misconception, declares in clear terms that Valsartan medicine made by Pakistani companies is not banned and only batches manufactured by the Valsartan raw material manufactured and supplied by Zhejiang Huahai Pharmaceuticals, China are being recalled. The companies can manufacture and sale Valsartan medicine made from raw material imported from other qualified sources.
In the best interest of patients, prescribers and healthcare professionals, DRAP issued this information. For Patients – an unexpected impurity has been found in the active ingredient used to make some Valsartan medicines. Only those Valsartan medicines affected in Pakistan 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 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. For Healthcare Professionals –NDMA has been detected in the Valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals. As a result, Valsartan medicines only containing the active substance from Zhejiang Huahai, China are being recalled in Pakistan.
Published in Daily Times, July 18th 2018.
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