A generic drug manufacturer has recalled three commonly prescribed blood pressure medications because of concerns they may contain small amounts of cancer-causing impurities.  The recalled medicines include the blood pressure medication Valsartan, which has been treated by several drug companies since July in a series of product recalls.
Generics manufacturer Mylan Pharmaceuticals recalled 104 lots of three drugs: Valsartan tablets, combination tablets with drugs valsartan and amlodipine, and combination tablets with valsartan and hydrochlorothiazide.
Tests showed that valsartan contained traces of N-nitrosodiethylamine or NDEA, a potential human carcinogen.
Amlodipine and hydrochlorothiazide in standalone form are not subject to recall.
Alternative medicines are available. Mylan said patients should consult their doctor or pharmacist before stopping their current medication.
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Throughout the recalls, doctors said stopping a drug without a substitution drug could cause more harm to a patient than continue the medication.
People with questions about callback can call 1-888-406-9305. You can see a list of Mylan's recalled medications here.
The Food and Drug Administration is investigating the cause of the contaminated drugs that were originally due to a large factory in China and later to a second factory in India. Both used a similar manufacturing process to produce valsartan globally and to deliver to generic companies.
Tests showed that factories made valsartan containing N-nitrosodimethylamine or NDMA, a potential human carcinogen.
In September, the FDA declared tests showed a second contaminant, NDEA, on certain valsartan medications.
Several pharmaceutical companies have announced recall of versions of valsartan, irbesartan and losartan.
The recalled drugs are part of a large class of drugs called angiotensin II receptor blockers. These medications work by dilating or relaxing the blood vessels, lowering blood pressure.
Consumers can see a full list of FDA updates on the recalls here.
FDA officials said the factories that delivered the contaminated drugs had been imported into the alert, which means they no longer ship medications to the United States.
Factories manufacturing pharmaceuticals abroad are controlled by the FDA. They are obliged to inform the regulatory authorities about changes in the production of the drug ingredients.
"We still do not understand the full cause of this problem," said Janet Woodcock, director of the FDA's Center for Drug Assessment and Research USA TODAY this week. "We understand a part of it, we do not understand all the steps that have led to it."
Woodcock said all "Sartan" medicines were tested to make sure they did not contain any impurities. She said no contaminants were found in Novartis' Diovan, the branded drug version of valsartan.
Drug companies are aware of the problem and need to conduct extensive testing, Woodcock said.
"I think those recalls would start now," she said. "We've had this import alert for quite some time, and the companies that buy from these sources should check and recall it."
She said the FDA will release the results of its cause-finding. The agency will also check its oversight.
"We do not want such incidents to happen," she said. "So we need to look at how we could manage the change processes in manufacturing processes."
Teva Pharmaceuticals has initiated a voluntary recall of two drugs used to treat high blood pressure Concerns about a potential cancer risk.
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