Author: Ken Alltucker / Source: USA TODAY
The Food and Drug Administration posted information on its website listing the blood pressure medications recalled for containing carcinogens. Here’s what to watch out for. USA TODAY
The Food and Drug Administration officials said Friday that some versions of the blood pressure-lowering drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer, triggering a widespread recall of the tainted drugs.
FDA officials said the cancer risk for any person who took valsartan that had the carcinogen nitrosodimethylamine, or NDMA, is small.
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.FDA Commissioner Scott Gottlieb and FDA Director Janet Woodcock said in a joint statement that investigators suspect the root cause of the contamination stemmed from a change in how the blood pressure drug ingredients were made.
“Overall, the risk to individual patients remains very small, although this doesn’t diminish the significance of this episode or our concerns,” the statement said.
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Drug companies recalled hundreds of lots of the front-line blood pressure and heart medications valsartan, losartan and irbesartan – alone or in combination with other drugs – after testing revealed the drugs had trace amounts of NDMA. Follow-up testing showed some batches of valsartan also contained another probable carcinogen, nitrosodiethylamine, or NDEA.
The recalled products are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which relax blood vessels. Many of these commonly prescribed drugs are not part of the recall. Consumers can check the agency’s website for a full list of recalled drugs.
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