Valsartan recall by FDA/ DRAP due to carinogenic impurities

The United States food and drugs authority (FDA) announced recently, a voluntary recall of several medicines containing valsartan following detection of an impurity.

Valsartan brands in Pakistan

Valsartan is a drug used in the treatment of hypertension and heart failure. It belongs to a class of drugs called angiotensin receptor blockers.

Various companies have marketed this drug for the treatment of hypertension and heart failure in Pakistan.

The research brand is available by the name of Exforge, Exforge HCT, Diovan and Co Diovan.

Other companies have also marketed this drug and are widely available all over Pakistan. These brands include Triforge, Extor, Valtec, Co valtec, Valtec-AM, Cova and many others.

These drugs are available in different strengths ranging from 40 mg, 80 mg, 160 mg to 320 milligrams.

Carcinogenic impurities in valsartan

The US food and drugs authority has recently alerted all the companies as well as the general public who are using this drug because of the contamination by NMDA as an impurity during its manufacturing.

NMDA is a substance which is a well-known carcinogen and has been associated with the development of various cancers in the body.

Other well known adverse effects of Valsartan and other angiotensin receptor blockers include hyperkalemia, hypotension, hypersensitivity reactions, and teratogenic effects when used during pregnancy.

FDA has announced a list of companies which are manufacturing this drug and found to have this impurity.

List of pharmaceutical companies which are registered in Pakistan and providing these drugs to Pakistani patients as provided by DRAP is given at the end of the article.

FDA has started conducting studies on the patients who have been using this drug for some time for the occurrence of carcinogenic effects.

Till the final results are available the FDA has asked the Healthcare professionals, the pharmacists, doctors, and patients using these drugs to discontinue using it.

How to switch to other anti-hypertensive medicines?

The patients need to consult their Healthcare providers to switch their hypertension medication containing valsartan.

This should preferably be switched to another group of drugs or to another brand which is not listed or found to have NMDA as impurities.

The health-care providers may switch Valsartan to other angiotensin receptor blockers like Irbesartan, olmesartan, losartan, and telmisartan.

Patients can also be switched to another group or class of drugs. These choices include calcium channel blockers, beta blockers, Alpha blockers, and diuretics.

The drug regulatory authority of Pakistan (DRAP) has notified the concerned departments and ministry of health to recall finished products containing valsartan manufactured or imported from Zhejiang Huahai pharmaceuticals.

Till the final decision is made, disposition of all products containing valsartan, prepared by the said company or the ones listed below should be stopped.

The Drug regulatory authority of Pakistan has also requested the healthcare workers to switch their patients to alternate drug regimens.

DRAP List of Valsartan-containing Products:

Products or raw material used by the following companies are imported from Zhejiang Huahai pharmaceuticals:

    • Amarant pharmaceuticals (Pvt) Ltd Karachi
    • Efroze chemical industries Karachi: (Angiotan and Angiotan H)
    • High Q pharmaceuticals Karachi
    • Pharmevo (Pvt) Ltd Karachi: (Avsar and Avsar plus, Nuval)
    • Safe Pharmaceuticals (Pvt) Ltd Karachi
    • Sami Pharmaceuticals (Pvt) Ltd Karachi
    • Tabros Pharma ( Pvt) Ltd Karachi: (Valtec and valtec Am)
    • Searle pharmaceuticals Lahore: (extor and co-extor)
    • Genetics pharmaceuticals Lahore

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