FDA issues voluntary recall of generic blood pressure drug

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The US Food and Drug Administration has announced a voluntary recall of valsartan. a widely prescribed blood pressure medication made in China, and follows a similar alert in the UK.

The New York Times reports that three companies that sell the generic drug, valsartan, in the US agreed to recall it after the FDA said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured.

The report says all of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. It is distributed in the US by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries; and Solco Healthcare. Solco, which is owned by Huahai Pharmaceutical, had about 45% of the market in 2017, according to John Brito, of Fore Pharma, the market research firm.

“We have carefully assessed the valsartan-containing medications sold in the US, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Dr Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research. “That is why we’ve asked these companies to take immediate action to protect patients.”

The report says the agency advised patients taking the drug to look at the manufacturer’s name on the label of their prescription bottle to determine if it is part of the recall. If the information is not there, patients should contact the pharmacy where they got it.

The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute. Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero, according to Fore Pharma.

“The recall is huge, based on the volume and the large number of patients it could have impacted,” said Brito, “but we believe this could get offset by other players stocking up in short term. Switch options are available for a hypertension patient.”

The report says Solco declined to comment, but in a news release, acknowledged that the recall stemmed from detection of a trace amount of NDMA. A spokesperson for Major Pharmaceuticals said they were recalling several lots and referred other questions to Teva, which supplies valsartan that they package and sell. Teva did not return calls for comment.


The alert concerns seven types of commonly used tablets manufactured by Dexcel Pharma Ltd and Accord Healthcare, says a Daily Mail report carried on the IoL site

It is not known how many patients are taking the pills but the UK’s National Health Service (NHS) issued a total of 424,625 prescriptions for them last year. Patients are being advised to continue taking the medication but to contact their GP to arrange to switch to an alternative.

The report says the UK’s Medicines and Healthcare Products Regulatory Agency said there was no evidence that patients had suffered harm and insisted the recall was only precautionary. Dr Sam Atkinson from the agency said: “We will communicate the outcome of our investigations and ensure that any other affected products are recalled. Our highest priority is to ensure that the medicines you take are safe.”

The New York Times report
FDA announcement
Report on the IoL site

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