Causes cancer: in the United States withdraw a popular drug to reduce blood pressure
An impurity that may cause cancer has been found in a commonly prescribed blood pressure drug, losartan, federal health officials said. Therefore, the manufacturer Torrent Pharmaceuticals has expanded the recall of the drug, which is being carried out for the fifth time.
The new review applies to three additional batches of losartan potassium tablets and two additional batches of losartan potassium / hydrochlorothiazide tablets, writes USA Today.
These lots contained levels of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) above the FDA's permissible daily intake levels. NMBA is a “potential human carcinogen,” the FDA says.
Since last July, hundreds of lots of blood pressure drugs valsartan, losartan and irbesartan have been recalled that contain traces of the carcinogens NMBA, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), the FDA said.
Drugs that block angiotensin II receptors act by expanding or relaxing blood vessels, thereby lowering blood pressure. However, this did not affect all of these drugs, so the FDA recommends that patients continue to use their drugs.
“The risk of patient harm may be greater if treatment is stopped immediately without any alternative,” federal health officials said in a statement.
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The FDA said the contaminants were likely introduced into the drugs as a result of changes in ingredient production at factories in China and India. “In the presence of certain chemicals and reaction conditions,” such changes can lead to contamination, as does the reuse of certain materials, such as solvents.
In January, the agency acknowledged that some versions of valsartan were sold with traces of a carcinogen for four years before regulators discovered contamination.
However, FDA officials said that the risk of developing cancer for anyone who took valsartan with the carcinogen N-nitrosodimethylamine or NDMA is low. FDA scientists have concluded that for every 8000 person who has taken the highest dose of valsartan for four years, one additional case of cancer may be added.
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