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Islamabad: The drug regulator has ordered the immediate recall of some heart medicines to contain a potential carcinogenic chemical.
an impurity, N-nitrosodimethylamine (NDMA), in the active pharmaceutical substance valsartan provided by the Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription drugs. The substance is a potential carcinogen suggesting that its long-term exposure may cause cancer.
However, the CLD orders will not affect drugs containing valsartan produced by other companies. Pakistan is among 23 countries that have separately announced the recall of several drugs with valsartan as a precautionary measure to protect the health of patients.
Reviews were motivated by the review of certain drugs by the EMA, a drug monitoring agency of the European Union. According to the EMA, he is studying the levels of NDMA in these drugs valsartan, its possible impact on users, and measures to reduce or eliminate the impurity of future batches. produced by the Chinese company. The review will also see if other Valsartan medicines are affected.
Doctors prescribe valsartan medications for patients with hypertension to reduce complications such as heart attack and stroke. They are also used by people with heart failure or attacks lately.
According to a competent official, the DRAP asked the pharmaceutical companies to name all products made from valsartan supplied by Zhejiang Huahai Pharmaceuticals. Additional guidance was also given to federal drug inspectors to compile an inventory of the active pharmaceutical substance of valsartan manufactured by Zhejiang Huahai and not to order it. in the public interest until the final decision of the authority.
The grievor stated that recall orders would apply to both locally manufactured and imported drugs. He added that the importers of valsartan supplied by Zhejiang Huahai included Amarant Pharmaceuticals, Efroze Chemical Industries, High-Q Pharmaceuticals, Pharm-Evo, Safe Pharmaceuticals, Sami Pharmaceuticals and Tabros Pharma of Karachi, and Searle Pharmaceuticals and Genetics Pharmaceuticals, of Lahore [19659008]. that the presence of NDMA was unexpected and that it would be related to changes in the manufacture of the active substance, the doctor asked the doctors to take the necessary steps to protect users of these drugs from the complications of NDMA and report side effects or unwanted effects. To the DRAP
He advised patients not to stop taking valsartan without the doctor's permission, warning that absenteeism without supervision could be dangerous. When he was contacted, the deputy director of the DRAP (Quality Control) Abdul Sattar Sohrani confirmed the recall orders and said that the pharmaceutical companies concerned had had a week to withdraw from the market the drugs made from the Zhejiang Huahai Valsartan. . He stated that the DRAP would strictly apply its recall orders.
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