Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option.If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled.Report any unexpected side effects with ARB-containing medicines, to Return it to your pharmacist when you get your new medication.FDA has determined the recalled ARBs pose an unnecessary risk to patients.FDA recommends that pharmacists provide a replacement medicine not affected by the recall or prescribers consider other available treatment options for their patient’s medical condition.FDA suggests health care professionals check the lists regularly for updates.Samples can also be affected and part of the recall.
Be certain to check samples to ensure affected products are not given to patients.Report any adverse reactions with ARB-containing products, to Lawsuits Over Losartan, Irbesartan Consolidated With Valsartan Recall Claims December 26, 2019 Written by: Irvin Jackson Add Your Comments
Drug Safety and Availability
18 January 2019 to 25 January 2019 – Solco Healthcare recalls seven lots of irbesartan-containing products, Torrent Pharmaceuticals’ expands its losartan recall to include an additional six lots (16 in total), and Macleods Pharmaceuticals recalls one lot of losartan potassium/hydrochlorothiazide.
"The risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment," federal health officials wrote in a statement.The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients.
Angiotensin II receptor blockers (ARBs) like losartan, valsartan and irbesartan are common medications used to treat high blood pressure. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled.
Get current information about recalls of blood pressure medicationsAn explanation of FDA's ongoing recall of Valsartan, Losartan, and IrbesartanValsartan, losartan, irbesartan and other “-sartan” drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure.Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards.Some manufacturers are recalling some medications containing amlodipine To find out if your medication has been recalled, you need the following information:Following is an example of an ARB medication label to help you identify the information on your medication:Note the manufacturer may be different from the distributor or labeler of your medication. In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Find out which specific blood pressure medications are affected by the recall FDA scientists concluded there would be one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years. NDEA appears to cause cancer in animals and is suspected to cause cancer in humans, according to lab tests. The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens NMBA, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), the FDA says.Hundreds of lots of the medication have been recalled since last July.The drugs, angiotensin II receptor blockers (ARBs), work by widening or relaxing blood vessels, thus lowering blood pressure. Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents.In January, the agency admitted that some versions of the drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer.However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. All recalls are due to the presence of NDEA. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens … NMBA is a "potential human carcinogen," the FDA says.