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Another voluntary recall of drugs used in the treatment of high blood pressure has been issued due to the detection in the active pharmaceutical ingredient of an impurity believed to be probably carcinogenic to humans by the US Environmental Protection Agency.
The Food and Drug Administration is alerting patients and health professionals to voluntarily recall a batch of Losartan Potassium / Hydrochlorothiazide (HCTZ) 100 mg / 25 mg tablets manufactured by Macleods Pharmaceuticals Limited. .
The recall is attributed to unacceptable amounts of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient losartan manufactured by the Indian company Hetero Labs Limited.
Macleods only recalls many drugs containing losartan in which NDEA has been detected beyond the provisional acceptable ingestion limit of 0.27 parts per million set by the FDA.
A number of drugs in the class of angiotensin II receptor blockers have been voluntarily recalled since July due to the detection of unacceptable levels of NDEA and / or N-nitrosodimethylamine (NDMA) in their active ingredient, such as losartan, valsartan. or irbesartan.
The FDA studies and tests all ARAs for the presence of NDEA and NDMA that may be a by-product of a manufacturing process change.
The FDA's investigation included setting acceptable intake levels for NDEA and NDMA and updating test methods to detect impurities in NDMA and NDEA.
NDMA and NDEA are chemical compounds of the nitrosamine class and both are considered a likely risk of cancer in humans at certain levels of exposure.
This year's voluntary boosters had involved many losartan potassium and hydrochlorothiazide tablets in combination with the active pharmaceutical ingredient manufactured by Hetero, which had unacceptable amounts of NDEA.
Patients are advised to continue taking their medications until their pharmacist replaces them, or until their doctor prescribes a different medication that addresses the same problem, as the risk of developing a drug may increase. the patient's health may be higher if the treatment is stopped immediately without alternative treatment. .
Losartan potassium tablets with diuretic hydrochlorothiazide are indicated in the treatment of hypertension and hypertensive patients with a disorder called left ventricular hypertrophy, in which the muscular wall of the left pumping chamber of the heart s & rsquo; # 39; thickens.
Macleods Pharmaceuticals Limited, based in India, said in its February 22 voluntary recall that it has not received any adverse reaction reports related to this recall to date.
Consumers should contact their doctor or health care provider if they have problems that may be related to taking or using this drug product.
The FDA has updated the list of recalled losartan products.
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