FDA Recalls Some Valsartan Drugs Due to Impurity

Henrietta Strickland
July 17, 2018

The U.S. Food and Drug Administration said it is recalling blood pressure and heart failure medications after cancer-causing agents were discovered.

The ingredient valsartan was found to have N-nitrosodimethylamine or NDMA, a substance that could cause cancer.

Authorities say the impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The presence of NDMA is "thought to be related to changes in the way the active substance was manufactured", the agency said.

Valsartan from Teva Pharmaceuticals Industries Ltd.

"That is why we've asked these companies to take immediate action to protect patients".

An important note to add for patients who are taking valsartan is that this medication is used to treat various other serious medical conditions and if a patient is taking the recalled medication, they should continue to take it until a replacement product is made available.

To determine if your specific medication has been recalled, look at the name of the drug and the company name on the prescription bottle label. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.

"The FDA is committed to maintaining our gold standard for safety and efficacy".

The FDA is investigating how much NDMA is in the recalled products and is trying to find out the possible effects on patients who have been taking them.

"O$3 ur drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications", assured Scott Gottlieb, FDA commissioner.

Updated 7/16/2018 at 5:30 p.m. PDT: This piece was updated to include information about Teva Pharmaceuticals USA's recall of valsartan medication.

Patients whose medication has been recalled are directed to contact a health care professional to discuss treatment.

Anyone taking the information should also call their doctor or pharmacist to figure out what medication they should take. "Recalls happen for many different reasons and this is a voluntary recall in numerous countries worldwide as well", said Yoo.

As swift as the FDA's response appears to be, the whole issue has re-ignited an important conversation regarding how the U.S. can ensure the safety of imported drugs in the future - especially as imported drugs become more and more common.

Other reports by Click Lancashire

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