valsartan

Drug Regulatory Authority of Pakistan (DRAP) has recalled several heart drugs containing a chemical impurity found in valsartan medicines that could cause cancer.

These medicines are used to treat patients with high blood pressure to reduce complications such as a heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.

DRAP has earlier banned 9 pharmaceutical companies’ drugs used to treat patients with heart complications, but now the number has grown to 12 companies, which are:

  • Amarant Pharmaceuticals
  • Efroze Chemical Industries
  • High-Q Pharmaceuticals
  • PharmEvo
  • Safe Pharmaceuticals
  • Sami Pharmaceuticals
  • Tabros Pharma
  • Searle Pharmaceuticals
  • Genetics Pharmaceuticals
  • Genome Pharmaceuticals
  • Wns Field Pharmaceuticals
  • Ferozsons Laboratories

Valsartan ban

DRAP also declared that this recall shall also be implemented on all medicines containing valsartan manufactured by Chinese company Zhejiang Huahai Pharmaceuticals whether locally manufactured or imported but not included in the above-mentioned list.

However, the DRAP orders won’t affect the medicines containing valsartan produced by other companies.

China’s Zhejiang Huahai Pharmaceutical voluntarily informed the European Medicines Agency (EMA) that it had identified N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer, in its valsartan. DRAP’S announcement was made a week after 22 other countries had conducted their respective recalls of valsartan.

Information for patients

  • An unexpected impurity has been found in the active ingredient used to make some valsartan medicines.
  • Only some valsartan medicines in Pakistan are affected and these are being recalled.
  • You should not stop taking your medicine unless you have been told to do so by your doctor.
  • You may be given a different valsartan medicine (or an alternative treatment) when you go for your next prescription.

Pakistani population has one of the highest risks of coronary heart disease (CHD) and a stroke in the world. According to the latest report by WHO, Heart disease deaths in Pakistan has reached 265,051 or 21.76 percent of total deaths. This alarming situation has caused major imports of the medicines to treat the said disease.

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