Blood Pressure Medications Recalled: According to an FDA recall notice, two types of blood pressure medication manufactured by Lupin Pharmaceuticals have been recalled due to the possibility of excessive quantities of a cancer-causing chemical in the product.
The business is voluntarily recalling all batches of irbesartan tablets in strengths of 75 milligrammes (mg), 150 milligrammes (mg), and 300 milligrammes (mg), as well as irbesartan/hydrochlorothiazide tablets in strengths of 150 milligrammes (12.5 mg), 300 milligrammes (12.5 mg), and 300 milligrammes (12.5 mg).
Lupin announced in January that it would no longer offer the tablets. Both of these medications are used to treat hypertension, also known as high blood pressure.
An investigation carried out during the company’s testing procedure revealed that some tested batches — but not finished product batches — included levels of N-nitrosoirbesartan that are above the limit set by the FDA, an impurity that has the potential to cause cancer.
“Although Lupin has received no reports of illness that appear to be related to this issue, the company has decided to recall all batches out of an abundance of caution,” the notice states.
Between Oct. 8, 2018, and Sept. 30, 2021, the company received four reports of illness associated with irbesartan tablets and no reports of illness associated with irbesartan/hydrochlorothiazide tablets, which includes the earliest date of shipment from the manufacturing site for any of the affected batches, according to the company. According to the corporation, the contaminant had nothing to do with the four diseases.
An impurity was discovered in a trio of high blood pressure drugs, prompting the recall of all three products.
In response to the discovery of an azido impurity at levels above what is deemed safe in the drugs Irbesartan, Losartan, and valsartan, several pharmaceutical companies have recalled the drugs.
Long-term exposure to azido impurity at levels higher than those regarded safe has the potential to raise the risk of cancer, according to the Canadian government.
Health Canada, on the other hand, recommended people to continue taking the medicine unless they were told to stop by a medical professional because “not treating your disease may represent a higher health risk.”
The three medications are angiotensin receptor blocker (ARB) tablets, sometimes known as “sartans,” that are prescribed to treat excessive blood pressure in order to reduce the risk of heart attack and stroke, among other things.
Sivem Pharmaceuticals Inc., Sanofi-Aventis Canada Inc., and other companies have joined Sandoz Canada Inc., Sanis Health Inc., Teva Canada Ltd., Sivem Pharmaceuticals Inc., and other companies in recalling some goods.
Companies that market sartans, according to Health Canada, should “conduct extensive analyses of their production processes and controls, as well as conducting testing as appropriate.”