Over the past few months, there has been a marked increase in the risk of possible human contaminants and cancer-causing substances amongst medications commonly prescribed for high blood pressure. The authorities are increasingly encouraging pharmaceutical giants to order the recall of such medications.
A press release made by Prinston Pharmaceuticals reveals its decision to order back one batch of Irbesartan and seven batches of Irbesartan HCTZ, two popular drugs that are widely prescribed to provide relief against heart failure and high blood pressure.
This order has come in the wake of the controversial detection of trace quantities of a strikingly shocking “impurity” that is present within an active pharmaceutical ingredient (API) that is created by Zhejiang Huahai Pharmaceuticals.
The Food and Drug Administration (FDA) has released a report that reveals that this “impurity” is basically N-nitrosodiethylamine, and the drugs were ordered back as they contained more than dangerous levels of this substance that are prohibited for daily consumption by the FDA. Earlier reports released by the AJC revealed that the substance is largely present amongst certain food items, drinking water and even air pollution. The International Agency for Research on Cancer has classified this impurity as a “human carcinogen”.
Irbesartan and Irbesartan HCTZ were commonly administered to patients being treated for heart failure, along with normalizing blood pressure levels. Moreover, Irbesartan is largely prescribed alongside amlodipine plus hydrochlorothiazide to lower high blood pressure levels.
This decision to order back batches of high blood pressure medications is one of the many such decisions that have surfaced during the last few months. Back in July, the FDA announced the decision of voluntary ordering back medications by several major pharmaceutical brands, including Mylan Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries and many others.
Earlier in November, Teva Pharmaceuticals announced their decision to order back the combination medications of Amlodipine and valsartan, and amlodipine, valsartan and hydrochlorothiazide.
Study Reference: Irbesartan and Irbesartan HCTZ Tablets Recall