Alert! FDA Recalls Blood Pressure Medicine Made in China Over Potential Cancer Risk – Check If Your Drugs Are Among Impacted

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Several drug companies have recalled medications for treating heart failure and high blood pressure as a dangerous cancer provoker component was found.

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Huge recall

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

The companies blamed the recall on the presence of N-nitrosodimethylamine (NDMA), an impurity thought to be produced because of changes in manufacturing that is classified as a probable cancer-causing agent.

All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare. Solco, which is owned by Huahai Pharmaceutical, had about 45 percent 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 United States, 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 F.D.A.’s Center for Drug Evaluation and Research. “That is why we’ve asked these companies to take immediate action to protect patients.”

Source: Getty Images

What you can do

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 agency also recommends that consumers determine if they are taking a recalled product, find the company-specific recall instructions, and contact their pharmacy and physician.

The specific information including returns and dates of the impacted medication will be provided by the pharmaceutical companies and posted to the FDA’s website so keep in touch for further actions.

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.

Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said he was concerned about quality control of generic medicines, like valsartan, made in China and India. He believes that manufacturers should be more transparent about where their active ingredients are made.

“It’s not just valsartan,” Dr. Lever said. “It’s becoming very difficult for me to write prescriptions at all. There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don’t know what’s what.”

By the way, do you know Google has invented the microscope that can detect cancer?

What medication are impacted? 

Impacted medication includes, “40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiration dates from July 2018 to Jan. 2020,” according to a statement. The company is asking pharmacies to “immediately return the product.”

The impacted medications were supplied by Teva Pharmaceuticals, and include Valsartan 80mg tablets and Valsartan 160mg tablets with the expiration dates of July 2018, Feb. 2019, or May 2019. (A full list of lot numbers can be found here.)

Teva Pharmaceuticals USA also confirmed the recall, saying in a statement that “29 lots of single and 51 lots of combination valsartan medicines” which were manufactured by Zhejiang Huahai Pharmaceutical and distributed by the Actavis label, were being recalled due to the detection of NDMA. (A full list of recalled medications can be found here.)


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Alert! FDA Recalls Blood Pressure Medicine Made in China Over Potential Cancer Risk - Check If Your Drugs Are Among Impacted
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Alert! FDA Recalls Blood Pressure Medicine Made in China Over Potential Cancer Risk - Check If Your Drugs Are Among Impacted
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Several drug companies have recalled medications to treat heart failure and high blood pressure as a dangerous cancer provoker component was found.
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