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While antihypertensive drugs continue to wreak havoc among drug manufacturers, the FDA has declared the safe use of 40 generic tablets.
The agency on Thursday released a list of 40 generic angiotensin II receptor blockers (ARBs) free of three potentially carcinogenic compounds associated with various "sartan" drugs, including valsartan and losartan.
The FDA issued a worldwide recall in 2018 after a US drug manufacturer discovered high levels of N-nitrosodimethylamine (NDMA) in the active ingredient valsartan it had purchased from a Chinese supplier. Since then, the FDA has discovered that NDMA, N-nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA – all considered dangerous at certain levels – can be created when the manufacture of sartan medications under certain conditions.
RELATED: Third carcinogenic impurity detected in US supply of blood pressure medications
The first global recall concerned all unexpired generic valsartan sold by Solco Healthcare, a US subsidiary of Huahai, and valsartan / hydrochlorothiazide (HCTZ) manufactured by Teva and Solco.
The recall was then extended to other "sartan" products because the impurities were found in the irbesartan API produced by Aurobindo (India) and in losartan products made using an API. of Zhejiang Huahai Pharmaceuticals (China).
In an ongoing investigation, the two leading FDA drug reiterators reaffirmed in a joint statement that generics whose carcinogen level was above the accepted limit would be temporarily dispensed to prevent a shortage of losartan, used to treat high blood pressure and prevent heart failure.
RELATED: FDA Temporarily Withdraws Impurity Standards As Losartan Shortages Brace
Outgoing FDA Commissioner Scott Gottlieb and Janet Woodcock, Director of the Center for Drug Evaluation and Research, said that the agency's scientists felt that they were using contaminated drugs temporarily. would not increase the risk of cancer in a "significant" way. "After careful evaluation of the safety data and consideration of the benefits and risks to patients, we believe that it is essential that patients have access to these drugs during the manufacture of losartan without impurity", says the release of Thursday.
Gottlieb and Woodcock said they expect carcinogen-free products to replenish the US supply of losartan within six months.
"We want to reassure patients that risks, such as strokes, of stopping these important drugs by far outweigh the low risk of continuing drugs containing these impurities," they said.
Following the recalls, a series of lawsuits have been filed against the drug manufacturers cited by the FDA, including the Indian drug manufacturer Aurobindo and Huahai.
RELATED: Walmart and Aurobindo sued while litigation over contaminated blood pressure medications
In October, Huahai told the Shanghai Stock Exchange that it has filed lawsuits in four states for its production of contaminated Valsartan.
In a Florida federal lawsuit, consumers have accused Walmart, Aurobindo, US drug maker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals of manufacturing and selling irbesartan containing substances that may exacerbate health problems .
In an effort to begin cleansing the valsartan market, the FDA launched a new generic of valsartan from India's Alkem Laboratories last month. The agency said that Alkem's copy of Diovan was free of NDMA and NDEA.
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