Published: Wed, July 18, 2018
Medicine | By Douglas Stevenson

FDA recalls blood pressure, heart failure medications after cancer-causing agents found

FDA recalls blood pressure, heart failure medications after cancer-causing agents found

Several drug companies have recalled medications containing valsartan, an off-patent ingredient used in generic medications to treat heart failure and high blood pressure.

According to the FDA, an impurity called N-nitrosodimethylamine, or NDMA, was found in the recalled drugs.

Not all valsartan-containing medications are being recalled, however. Twenty-two other countries, including Germany and Canada, recalled it last week.

The FDA is investigating how much NDMA is in the recalled products and is trying to find out the possible effects on patients who have been taking them.

The human carcinogen NDMA is an organic chemical that is also used to make liquid rocket fuel, softeners, and lubricants.

Patients are urged to look at the drug name and company name on the label of their prescription bottle to determine whether a specific product has been recalled.

Novartis spokesman Eric Althoff said after the initial recall last week that products sold in the United States were not affected by this recall, but the FDA's ongoing review and laboratory tests found otherwise.

It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare. "This is why we've asked these companies to take immediate action to protect patients", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. The FDA believes NDMA was found in the substance due to how it was manufactured.

"The FDA is committed to maintaining our gold standard for safety and efficacy".

Officials report that Solco Healthcare LLC.is notifying distributors and consumers by letter and email arranging for return of the recall product.

Patients should contact their doctor or pharmacist if their medication is part of the recall.

The FDA's investigation into the drug will continue.

Medical City McKinney cardiologist Dr. Dale Yoo estimates that ten percent of his patients use medications containing valsartan and recommends no patient stop taking the medication without talking with his or her doctor.

Apple, iPhone, and iPad are trademarks of Apple Inc., registered in the USA and other countries. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Like this: