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A generic drug manufacturer recalled three commonly prescribed medications for high blood pressure, fearing to include small amounts of carcinogenic impurities.
The recalled medications all include valsartan, a medication for hypertension, which has been the subject of a series of recalls made by several pharmaceutical companies since July.
The generic drug company Mylan Pharmaceuticals has recalled 104 batches of three drugs: valsartan tablets, combination tablets with valsartan and amlodipine drugs and valsartan and hydrochlorothiazide combination tablets.
The tests revealed that valsartan contained traces of N-nitrosodiethylamine, or NDEA, a possible carcinogen to humans, the company said.
Amlodipine and hydrochlorothiazide in an autonomic form are not subject to the recall.
Alternative medicines are available. Mylan said patients should consult their doctor or pharmacist before stopping their current treatment.
During the recalls, the doctors said that stopping a drug without replacement medication could be more detrimental to the patient than continuing to take it.
Those who have questions about the recall can call 888-406-9305. They can consult a list of the medicines recalled by Mylan here.
The Food and Drug Administration investigates the cause of the contaminated drugs, initially located in a large factory in China, and then in a second in India. Both have used a similar manufacturing process to manufacture and supply valsartan to generic companies around the world.
The tests showed that the plants manufactured valsartan containing N-nitrosodimethylamine, or NDMA, a possible carcinogen for humans.
In September, the FDA said the tests revealed the presence of a second contaminant, NDEA, in some valsartan-based medicines.
Several pharmaceutical companies have announced recalls of versions of valsartan, irbesartan and losartan.
The recalled drugs are part of a broad class of drugs called angiotensin II receptor antagonists. These medications work by enlarging or relaxing the blood vessels, thus lowering blood pressure.
Consumers can see a full list of FDA updates on recalls here.
FDA officials said factories supplying the contaminated drugs had been alerted to import, meaning drugs are no longer shipped to the United States by these manufacturers.
Factories manufacturing drugs abroad are subject to FDA inspection. They are required to inform regulators of changes to the way they manufacture the ingredients of the drug.
"We still do not understand the root cause of this problem," said Janet Woodcock, director of the FDA's Center for Evaluation and Drug Discovery, at USA TODAY this week. "We understand some of it, we do not understand all the steps that led to it."
Woodcock said that all "sartan" drugs are tested to make sure they do not contain any impurities. She pointed out that no contaminants had been found in Novartis' Diovan, the drug version of valsartan.
Drug companies are aware of the problem and are required to do extensive testing, Woodcock said.
"I think these reminders would begin to happen now," she said. "This import alert has been in place for quite a long time and we asked companies buying from these sources to check and remember."
She said the FDA will release the results of its root cause investigation. The agency will also review its supervision.
"We do not want such incidents to happen," she said. "So we will have to look at how we managed the change control oversight of the manufacturing processes."
© 2018 USATODAY.COM
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