FDA recalls high blood pressure, heart failure medication due to cancer risk

Henrietta Strickland
July 18, 2018

Some drugs containing the active ingredient valsartan may contain N-nitrosodimethylamine, which is classified as a probable human carcinogen based on results from laboratory tests.

The Food and Drug Administration announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs.

Huahai has said it is unable to determine how much it will lose from the recall, but its own data shows that sales of valsartan, which is mostly sold to North America, Europe, India, Russia and South America, totaled CNY328 million (USD49 million) a year ago, compared with total revenue of CNY5 billion (USD749 million). Its share price [SHA:600521] closed down almost 7.1 percent at CNY21.78 (USD3.26) today, after rising for most of last week.

The specific products impacted are valsartan sold by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, along with valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals. If you are unable to find that information on the label, contact the pharmacy where you purchased your medication.

The FDA recommends that patients continue taking the medication until they can get a replacement, because it is used to treat "serious medical conditions".

The ministry said it withdrew all the pharmaceutical products that contain the active substance, once it received the memo.

Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share.

If your medicine is listed in the recall, you should contact your pharmacy or doctor to discuss treatment.

Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies.

The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products. "This is why we've asked these companies to take immediate action to protect patients". Solco Healthcare's information is already on the FDA's website, information from Major Pharmaceuticals can be found on its website, and early Monday evening Teva Pharmaceuticals USA released a statement with information about the recall.

The agency encourages patients and healthcare professionals to report any adverse reaction to the FDA's MedWatch program.

Included in the announcement is Solco Healthcare LLC., which is recalling all lots of 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 to the retail level.

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