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3 more blood pressure medicines recalled because of cancer: you should know the following



One generic company has recalled three commonly prescribed blood pressure medicines for concerns that they might contain small amounts of cancer-causing impurities.

The recalled drugs include the blood pressure medication Valsartan, the subject of a series of reminiscent of several pharmaceutical companies since July.

Generics manufacturer Mylan Pharmaceuticals appointed 104 lots of three medications: valsartan tablets, combination tablets containing the drugs valsartan and amlodipine, and combination tablets containing 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.

Throughout the recalls, doctors said that stopping a medication without a replacement drug could do more harm to a patient than continuing with the medication.

People with questions about the recall can be called 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 stated tests showed a second contaminant, NDEA, on certain valsartan medications.

Several pharmaceutical companies have announced recalls 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 here a complete list of FDA updates on the recalls.

FDA officials said the factories that supplied the contaminated medicines had been imported into the alert, meaning that no medicines are being shipped from these manufacturers to the United States.

Factories manufacturing pharmaceuticals abroad are subject to FDA inspection. 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 these recalls would start to drain 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 overlooked the control of change processes in manufacturing processes."

© 201

8 USATODAY.COM


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