Valsartan Recall: FDA Finds Human Carcinogen in Blood Pressure Medications Containing Valsartan
The Food and Drug Administration recently announced a voluntary recall of widely-prescribed blood pressure medications containing valsartan over cancer concerns.
Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals USA issued voluntary recalls at the FDA’s request. The recall was made after the FDA reported that a potentially carcinogenic impurity, NDMA (N-nitrosodimethylamine), was found in the drugs.
NDMA is a probable human carcinogen which is a substance that can cause cancer. At this time, the presence of NDMA in valsartan is believed to be caused due to the change in the manufacturing method of the active pharmaceutical ingredient.
Which Medications Are Included in the Valsartan Recall?
Actavis
Recalled: 07/17/2018
Product Description: Valsartan and Valsartan Hydrochlorothiazide Tablets
Recall Reason: Impurity detected in the API is N-nitrosodimethylamine (NDMA)
Company: Teva Pharmaceuticals USA
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Recalled: 07/17/2018
Product Description: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg
Recall Reason: Detection of a Trace Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA)
Company: Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Major Pharmaceuticals
Recalled: 07/13/2018
Product Description: Valsartan tablets, 80mg USP and 160 mg USP
Recall Reason: May contain the probable carcinogen N-nitrosodimethylamine (NDMA)
Company: Major Pharmaceuticals
FDA Action Against Valsartan
The FDA is continuing to review and investigate the levels of NDMA found in medications containing valsartan. In addition, the agency will be investigating and assessing possible effects on patients who have taken the drugs. The FDA is also said to be looking for possible changes to the manufacturing process that will reduce or eliminate the impurity from future batches.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb, M.D. said.
The Food and Drug Administration recently announced a voluntary recall of widely-prescribed blood pressure medications containing valsartan over cancer concerns.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our 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.”
The FDA has stressed the importance that patients DO NOT stop taking the recalled products altogether – the danger of abruptly discontinuing use of this medication greatly outweighs the risks associated with short-term NDMA exposure – patients should rather contact their healthcare provider right away to discuss alternative medication options.
Recent Developments
Hiring A Valsartan Lawsuit Attorney
Our attorneys are currently evaluating and investigating claims on behalf of patients who have been diagnosed with cancer as a potential side effect of ingesting a known human carcinogen. If you have been diagnosed with cancer or lost a loved one after ingesting valsartan, please contact us immediately.
In many cases, filing a valsartan lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, or even funeral expenses. In other cases, people file lawsuits because they want to make a difference and prevent others from suffering through the same horrors they have.
To discuss the specifics of your potential valsartan lawsuit in a free and confidential consultation, contact us today or submit your case for evaluation below.
Let Van Wey, Metzler & Williams help you receive compensation from these irresponsible pharmaceutical companies who place profit over public safety.
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