Resident affected by medicine recall

ELKINS — An Elkins resident was stunned to discover that a medication she was prescribed to treat high blood pressure is currently on a nationwide voluntary recall list, and she is hoping to warn other patients.

At the end of July, Solco Healthcare U.S. issued a notice to patients that a nationwide voluntary recall was in place regarding several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.

The Food and Drug Administration reports that the recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled.

“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” according to the FDA. “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

The Elkins resident, who wished to remain nameless, said she has been taking Valsartan for the past 10 years daily up until she received notice about the recall from Walmart’s pharmacy. Since the recall, the resident has stopped taking Valsartan, but has replaced the medication. Currently, she is only taking Clonidine, which she was taking along with Valsartan.

Since taking just the Clonidine, the resident says her blood pressure is stable.

The FDA reports that Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China.

“Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company,” states the FDA in a press release. “Zhejiang Huahai 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.”

The Elkins resident said she is “appalled” to learn that the medication was being manufactured in China and is currently on recall.

“I just can’t believe it,” the resident said.

Now, she is hoping to warn community members about the recall and to stress the importance of keeping up-to-date with any and all medications.

Because valsartan is used in medicines to treat serious medical conditions, the FDA recommends patients taking the recalled valsartan-containing medicines to continue taking their medicine until they have a replacement product. The FDA advises that in order to determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

Patients should also contact their health care professional if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.


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