Popular Blood Pressure Drug Irbesartan Recalled by FDA Over Potential Cancer Risk

By Jack Phillips

The U.S. Food and Drug Administration (FDA) has announced the recall of popular blood pressure medication Irbesartan, after finding an impurity that could cause cancer, months after it recalled Valsartan over similar reasons.

The agency discovered the pills contain N-nitrosodiethylamine (NDEA), classified as a potential human carcinogen. NDEA is used to make rocket fuel and is a byproduct of fish processing and the making of certain pesticides.

Twenty-two of the recalled batches have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, and they were produced between January 2016 and December 2017, said the FDA in a news release on Oct. 26. They’re in 30- or 90-count bottles of 75 mg, 150 mg, or 300 mg tablets.

The lot of Irbesartan, used to treat high blood pressure and hypertension, is being recalled by the FDA on behalf of Sciegen Pharmaceuticals. Aurobindo Pharma Limited is voluntarily recalling the drugs and has notified Sciegen Pharmaceuticals.

“Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is arranging for the return of all available Irbesartan drug substance. Aurobindo Pharma Limited has further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that has been identified by Aurobindo Pharma Limited,” said the FDA in the release.

If you have one of the affected bottles, you should contact your doctor before you stop taking the medicine or throw it out, said the FDA announcement, which noted: “The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”

“Patients who are on Irbesartan should continue taking their medication,” the agency said. Meanwhile, “Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan,” it said.

A full list of the recalled products can be found on the FDA’s website (pdf). Labels of the affected products can be seen here (pdf).

Valsartan Update

This month, prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a massive recall of much of the drug’s supply (as seen in the top video), reported Reuters.

Chinese pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals recalled valsartan from consumers in the United States in July after finding traces of a probable carcinogen.

According to the National Average Drug Acquisition Cost (NADAC) survey for last month, prices for 160-milligram and 80-milligram tablets of the drug more than doubled last month from August rates.

drugs china
Chinese workers preparing to destroy fake medicines seized in Beijing, on March 14, 2013. The U.S. Food and Drug Administration announced on July 13, 2018 the recall of the heart medicine valsartan, made by Chinese firm Zhejiang Huahai, which was found to be contaminated by a carcinogen. (STR/AFP/Getty Images)

The U.S. Food and Drug Administration in late September halted imports of drug ingredients made by Zhejiang Huahai Pharmaceuticals after a massive recall of one of its drugs over cancer-causing ingredients.

“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times several months ago about the recall of valsartan.

Reuters contributed to this report.

From The Epoch Times

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