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Millions Exposed to Probable Carcinogens in Blood Pressure Medication

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Six months ago, drug companies began recalling blood pressure medications due to contamination by probable human carcinogens. Now, the U.S. Food and Drug Administration says as many as 2 million people around the world have been exposed.

As first announced in July, some lots of the generic drug valsartan contained trace amounts of the carcinogen nitrosodimethylamine (NDMA) and nitrosodiethylamine (NDEA). Valsartan and other related “sartan” drugs belong to a drug class called angiotensin II receptor blockers, which work by relaxing blood vessels to treat high blood pressure.

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Losartan and irbesartan were also found to contain NDEA. Not all versions of these drugs are part of the recall though; for example, brand name versions including Diovan, Avapro and Cozaar are not affected. You can check the FDA website to find out if your specific drug has been recalled.

The risk to patients is “very small,” FDA officials said in a statement on Friday, adding:

FDA scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA, for four years (the time we think the affected products had been on the U.S. market), there may be one additional case of cancer beyond the average cancer rate among those 8,000 Americans.

The agency said people affected by the recall should continue taking their medication until their pharmacist replaces the drugs or their doctor prescribes another treatment. Stopping the drug could be more harmful than staying on it.

The contamination occurred in manufacturing facilities in China and India for four years before the carcinogen was detected last summer, FDA officials said. Officials said contaminants are created when “specific chemicals and reaction conditions are present … and may also result from the reuse of materials, such as solvents.”

Past inspections of a Chinese factory found issues like fraying gaskets and rusted screws. In a factory in India, workers shredded documents before the inspection in 2016 and equipment wasn’t regularly cleaned.

The FDA admitted there may be shortages of these drugs in the U.S. due to the recalls.

Getty photo by MJ_Prototype

Originally published: January 31, 2019
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