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FDA Warns About Blood Pressure Medication Against Recall



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"Overall, the risk for individual patients remains very small, although this does not reduce the significance of this episode or our concerns. FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Assessment and Research, said in a statement released Friday.

The most recent reminder occurred on January 1

8, when Prinston Pharmaceuticals announced a voluntary withdrawal from one batch of irbesartan tablets and seven batches of irbesartan HCTZ tablets, widely used blood pressure medicines. FDA

Most of the identified lots are contaminated with traces of NDEA or NDMA, N-nitrosodimethylamine, which the FDA has classified as a "likely carcinogen for humans." Irbesartan These environmental pollutants are found in water and food, including meat, dairy products and vegetables.

The drug used for generic versions of the drug has the potential to generate the carcinogenic compound. In the summer of 2018, the FDA warned the Chinese company Zhejiang Huahai Pharmaceutical Co. that some generic drugs containing valsartan contain NDMA impurities and pose a potential safety hazard. The FDA issued a warning letter to the company citing several manufacturing violations, including impurities control and cross-contamination from one production line to another.

"Companies knew there was a problem, but they did not fix it for six. "said Rosemary Gibson, a health expert at the Hastings Center and author of" China Rx: Exposing the Risks of America's Relationship to China for Medicine. "" This is no accident, this is a serious problem.

An FDA spokeswoman told NBC News that the agency can not predict how long withdrawals will continue.

Nearly 60 million prescriptions are written for losartan in 2016 – the 9th most prescribed drug in the US – and nearly 14 million for valsartan or a drug that includes it. This year, another 3.6 million recipes for irbesartan have been written.

No adverse effects have been reported by drug company staff, but experts believe that foreign companies can minimize health risks. to an acceptable level of NDMA per tablet, "Gibson told NBC News. "This is far higher than the level the FDA has found in other valsartan products."

The FDA has an exhaustive list of medicines that can be searched for under a trademark.


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