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New Drugs Added to FDA’s Recall List, Some Include Valsartan

— September 5, 2018

New Drugs Added to FDA’s Recall List, Some Include Valsartan

Valsartan, a drug that is used to treat high blood pressure and heart failure, has been recalled by the Food and Drug Administration.  This means some drugs that list valsartan as a component are being pulled by the agency, although the announcement doesn’t affect all.  The recall came about after lab tests discovered the drugs could have been tainted with a substance linked to a higher risk of cancer if ingested in fairly high amounts over a long period of time.  Hydrochlorothisazide has also been added to the latest list.

N-nitrosodimethylamine (NDMA), which was found in the recalled drugs, is listed as a possible carcinogen by the Environmental Protection Agency (EPA).  It is an organic chemical used to make liquid rocket fuel.  NDMA can be introduced through certain chemical reactions, inadvertently.  Pills sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, H J Harkins Company, Northwind Pharmaceuticals, Prinston Pharmaceutical Inc. (Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (Major Pharmaceuticals), and Teva Pharmaceuticals USA (Actavis) have all been added to the list.  The drugs were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, China, which said it notified authorities as the chemical byproduct was discovered.

New Drugs Added to FDA's Recall List, Some Include Valsartan
Photo by chuttersnap on Unsplash

“We published our recall notice at midday on July 13 in China and overseas and published the U.S. market recall notice on July 14 Beijing time…all the drug materials for the Chinese market were recalled by July 23,” the company stated.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards.  This is why we’ve asked these companies to take immediate action to protect patients.”  The FDA is currently working with drug manufacturers “to ensure future valsartan active pharmaceutical ingredients are not at risk,” according to its website.  Twenty-two other countries had previously pulled the same list from the market.

Until further research is conducted, the agency is advising anyone taking a product that includes valsartan to call their prescribing pharmacy for more information.  Not all valsartan drugs are involved, so a pharmacist might switch a patient to another version of the drug made by a company that’s not on the list.  Patients should continue to use their current medication as directed until otherwise advised.  Physicians may also choose to prescribe a different medication.

“The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful,” Dr. Mary Ann Bauman with the American Heart Association said. “You don’t want to jump to any conclusions on your own about this medication, or any medication for that matter.  Definitely talk with your doctor first.”

FDA scientists estimate that if 8,000 people took the highest dose of valsartan, which is 320 mg, from the recalled batches every day over a course of four years, there may be one additional case of cancer.  Thus, it is more important to continue taking the medication until a pharmacist says otherwise.  Completely discontinuing use could pose more dire health risks. 


FDA expands recall of blood pressure drug due to cancer concern

FDA expands recall of common heart medication Valsartan

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