Members of the Henryetta and surrounding communities and countians should be aware of a voluntary recall of several drug products which contain the active ingredient, valsartan, according to a press release issued July 13 by the U.S. Food and Drug Administration (FDA).

Upon researching valsartan, brand name drugs that use the ingredient are Diovan and Diovan HCT.

Valsartan is used to treat high blood pressure and heart failure.

The mass recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in recalled products. NDMA is classified as a probably human carcinogen or a substance that could cause cancer based on results from laboratory tests performed by the FDA.

Not all products containing valsartan are being recalled so please check with your doctor or health care professional if you suspect you are taking a medication with valsartan.

FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb, MD, said.

“When we indentify lapses in the quality of drugs and problems with their manufacturing that have taken the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

Important information for patients and health care professionals includes:

• Because valsartan is used in medicines to treat serioues medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product;

• To determine whether a specific product has been recalled, patients should look at the drug name and company name on the lable of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine;

• If a patient is taking one of the recalled medicines, they should follow recall instructions provided by the specific company. This information will be posted to the FDA website and clicking on Drugs/DrugSafety/DrugRecalls;

• Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatement, which may include another valsartan product not affected by this recall or an alternative treatment option.

The following companies are recalling all lots of non-expired products that contain valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China: Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals, Inc.

“We have carefully assess the valsartan-containing medications sold in the U.S. 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,” Janet Woodcock, MD, Director of the FDA Center for Drug Evaluation and Research, said.

FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

If you would like to contact the FDA, call 1-888-INFO-FDA or e-mail: druginfo@fda.hhs.gov.