Several Valsartan Blood Pressure Medications Recalled Due to Cancer Concerns

A voluntary recall has been issued for several medications used to control blood pressure and treat heart failure.

The recall was issued after an impurity in the medication’s active ingredient, valsartan, was linked to cancer. The US recall came after 22 other countries issued recalls of their own.

Chemical Linked to Cancer

According to the statement issued by the US Food and Drug Administration regarding the recall,

“[It’ 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 an organic chemical that is part of a family of potent carcinogens and has historically been used to make liquid rocket fuel, as well as lubricants and softeners. The chemical can also be produced during chemical reactions and is a byproduct of some pesticide and rubber tire manufacturing processes.

Lab studies conducted on animals show that NDMA is toxic and can result in the development of kidney, liver, or respiratory tract tumors. It can also present an immediate danger when taken in certain quantities. For instance, high levels of exposure are also linked to liver damage.

Several Valsartan Manufacturers Affected by Recall

The Valsartan and Valsartan/Hydrochlorothiazide recall affects the following manufacturers:

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

These specific medications were chosen because they failed to meet FDA standards regarding safety. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “This is why we’ve asked these companies to take immediate action to protect patients.”

FDA officials reported the carcinogen’s presence is believed to be linked to changes in the way the active substance was manufactured.”

Who Might Be Affected by the Valsartan Recall?

Valsartan is used in adults and in children age 6 years and older to treat high blood pressure. It is also used in adults for treating heart failure and to boost the chance of survival following a heart attack.

The medicine works by blocking the action of certain natural substances that cause blood vessels to tighten. This allows blood to flow more smoothly and the heart to pump more efficiently.

Valsartan is also sometimes used to treat diabetic nephropathy (kidney disease in people with diabetes and high blood pressure).

What Should You Do If Your Medication is Affected by this Recall?

To determine whether the medication you are using might be affected by this recall, check the name of the drug and company name on the label of the prescription bottle. If your bottle has no label, you can contact your pharmacists or doctor to determine the manufacturer of your medication.

If you are taking Valsartan or Valsartan/Hydrochlorothiazide, or any other blood pressure or heart failure medication you’re concerned could be linked to the recall, you should contact your doctor.

Never stop taking a prescribed medication without speaking to your doctor first.

Valsartan, also sold under the brand name Diovan, is one of the most commonly prescribed blood pressure medications on the market.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.