Drug Regulatory Authority of Pakistan Recall VALSARTAN

DRAP has issued a recall alert on the basis of information shared by European Medicine Agencies (EMA). An impurity has been detected in the “VALSARTAN” active substance supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

adAccording to the Journal of Pakistan Medical Association & National Health Survey (2011), 33% of the Pakistani population above the age of 45 has hypertension, with 19% prevalence in people of age 15 or above. The statistics have only risen since then, which means the consumption of Valsartan medicines is pretty high in the country.

The impurities found in these raw materials — from which Valsartan is manufactured — were substances that could cause cancer. DRAP Recall alert stated that a total of nine Pharmaceuticals Companies in Pakistan are on the DRAP recall list, and this list does not include Getz Pharma and its’ products, Cova, Covam, & Cova-H.

A statement issued by Getz Pharma’s said that its Valsartan brands are manufactured using raw material/Active Pharmaceutical Ingredients (APIs) sourced from suppliers who are qualified as per WHO guidelines.

Individuals who have been consuming Valsartan brands are requested to visit their health care consultants to take necessary measures and protect themselves!

Following important information are for patients using valsartan :

  • 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.
  • 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.
  • National authorities are contacting pharmacists with information on the medicines to be recalled.
  • EMA is now evaluating potential impact on patients of the exposure to NDMA in valsartan

medicines. Further information will be provided once available.

July 16, 2018

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