FDA Recalls Common Heart Drug Over Cancer Concerns

Three U.S. companies have voluntarily recalled drugs that contain the active ingredient valsartan, a generic drug used to treat heart failure and high blood pressure.

The drugs are being recalled because an impurity, N-nitrosodimethylamine (NDMA), which has been linked to cancer, was found in the medications. All three companies recalling the drugs buy valsartan from the same Chinese manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd.

According to the U.S. Food and Drug Administration (FDA), NDMA is classified as a “probable human carcinogen” (cancer-causing agent.) “We don’t know, however, how much NDMA could possibly cause cancer,” says Michael Ganio, PharmD, director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists in Bethesda, Maryland.

The FDA suspects that NDMA was somehow introduced during the manufacturing process.

“One possibility could be wastewater that contained the NDMA and made its way into the factory where the valsartan was manufactured,” says Ganio.

Not all drugs containing valsartan have been recalled, and the FDA is advising patients to check the FDA website for the names of the companies recalling their valsartan products and then check their medication bottles to see if they are taking a recalled version.

“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. This is why we’ve asked these companies to take immediate action to protect patients,” says Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

The companies that have announced a recall include:

• Major Pharmaceuticals
• Solco Healthcare
• Teva Pharmaceuticals Industries Ltd.

But even if the brand you are taking has been recalled, don’t stop taking the drug before speaking with your physician, advises the FDA and the American Heart Association.

“Patients taking the recalled valsartan-containing medicines should consult their doctor or pharmacist and continue taking their medicine until they have a replacement product, as the conditions the medication treats are serious, and patients could be harmed if they suddenly stop taking it,” says Mary Ann Bauman, MD, a cardiologist and spokesperson for the American Heart Association.

Some drugs containing valsartan were recalled by the European Medicines Agency (EMA), which regulates medications for the countries of the European Union, about a week and a half before the FDA announced the recall in the United States. Both the EMA and the FDA say they are looking at what measures can be taken to reduce or eliminate the impurity from future batches produced by Zhejiang Huahai Pharmaceutical.

Ganio says the FDA has “clear expectations on purity of medications and they have inspectors that look at manufacturing facilities, but they can’t check every product all the time. It’s up to the manufacturers to follow the guidelines the FDA has set forth.” Ganio says it’s rare for a drug to be recalled because of an impurity and says ASHP hopes the valsartan recall will help increase funding for FDA inspectors. “FDA has asked for more resources for this very reason, says Ganio, “because drug manufacturing has become more global.”