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A Common Blood Pressure Drug is Recalled due to Contamination

It’s usually an essential when visiting the doctor.  A blood pressure check.

You might be one of about 75 million American adults (29%) that have high blood pressure (hypertension). That’s 1 in every 3 American adults. “Anyone, including children, can develop high blood pressure. It greatly increases the risk for heart disease and stroke, the first and third leading causes of death in the United States,” according to the American Heart Association.

High blood pressure can be controlled in a variety of ways.  Often, mild hypertension will normalize simply through a change in diet and exercise.

More serious cases will need a doctor prescribed medication.

In mid-July (2018), the US Food and Drug Administration (FDA) put doctors and patients on high alert after several drugs that were made in China were found to contain a possible human carcinogen.

Three companies based in the US have agreed to stop selling specific medications that contain valsartan – an ingredient commonly used to treat high blood pressure and heart failure.

“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 Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

To be clear, not all products containing valsartan are being recalled, just the ones that were found to contain N-nitrosodimethylamine (NDMA), which is classified by the US Environmental Protection Agency (EPA) as a probable human carcinogen.

Every single one of these contaminated products was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd.

The FDA is warning patients who take valsartan to make sure their medication was not manufactured by the offending company. If the medication’s label does not explicitly name the manufacturer, or if there is any confusion whatsoever, the agency is advising patients to call their doctor or pharmacy and make sure their drug is not part of the recall.

For some patients, however, valsartan is a life-saving drug, and giving up treatment is not an option. In these cases, the FDA has told patients to continue taking the drug until their health care provider is able to provide them with a substitute.

In most cases, including this one, drugs found to have possible unsafe side effects are voluntarily taken off the market by the manufacturers.

Then there are other cases where a pharmaceutical continues to be on the market despite safety warnings, or an adverse effect hits patient before it is discovered that the drug is harmful.

Theodoros & Rooth takes cases of product liability very seriously, whether it is a medical drug or another product on the market.   If you believe that you or a loved one has been harmed by a product that you believed to be safe, this could be caused by negligence on the part of the manufacturer.  The attorneys at Theodoros & Rooth want to hear about your experience.  If we determine you have a solid case, we will represent you aggressively until justice is served.

Photo courtesy U.S. Department of Human Services