Joanna Szabo  |  December 3, 2018

Category: Legal News

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FDA Adds to Recall List of Valsartan DrugsThe U.S. Food and Drug Administration has added more medications to its list of valsartan drugs included in a recall first announced in July 2018. The recall was instigated because certain valsartan drugs—though not all—have been tainted with an impurity that may be able to cause cancer.

Most recently, Teva Pharmaceuticals added new valsartan combination drugs to its recall, according to a USA Today article. Teva is now recalling all lots of drugs that combine valsartan and amlodipine, including combinations of valsartan, amlodipine and hydrochlorothiazide, that were manufactured by Mylan India.

If you or a loved one were affected by the tainted valsartan drugs included in the FDA’s recall, you may qualify to join an ongoing valsartan lawsuit investigation.

Background of Valsartan Drugs

Valsartan is a generic ingredient used to help patients with high blood pressure, as well as to treat heart failure. Patients recovering from a heart attack may also be prescribed valsartan in order to reduce their risk. Some valsartan medications are combination drugs that mix valsartan with other cardiovascular drugs like amlodipine and hydrochlorothiazide.

The FDA’s Recall of Valsartan Drugs

This past summer, the FDA announced a voluntary recall—that is, the manufacturers agreed to pull the products—of valsartan products that have been tainted with an impurity known as N-nitrosodimethylamine, or NDMA.

The U.S. Environmental Protection Agency (EPA) considers NDMA a possible carcinogen, or substance capable of causing cancer. Because of certain chemical reactions, NDMA may have been accidentally brought into the manufacturing process of valsartan drugs. The FDA learned that the drug’s manufacturer, Zhejiang Huahai Pharmaceuticals, had found NDMA in some of its valsartan drugs, and took steps to prevent contaminated products from affecting U.S. patients. Zhejiang Huahai Pharmaceuticals has been placed on an import alert, so its pharmaceutical products are not permitted to enter to the U.S. for the time being.

After the initial recall was announced in July 2018, the FDA has conducted testing of valsartan-containing products to determine whether they too were affected by the impurity and therefore should be included in the recall. Though the recall has not affected all valsartan drugs, the FDA is continuously updating its list of valsartan drugs affected by the recall. Recently, the FDA added a group of products sold under the name RemedyRepack to the list.

The FDA reports that this NDMA impurity may have been affecting valsartan drugs for up to the last several years. Valsartan drugs have also been recalled in at least 22 other countries.

For patients who are currently taking one of the valsartan drugs included in the FDA recall, the FDA recommends they keep taking their valsartan drugs until they consult their doctor to decide on a suitable replacement medication.

Filing a Lawsuit Over Recalled Valsartan Drugs

If you or someone you love has taken one of the valsartan drugs included in the FDA recall, and has since suffered from cancer or other side effects, this may be the result of exposure to the NDMA impurity, and you may be eligible to pursue litigation. Although filing a lawsuit cannot, of course, undo the side effects caused by contaminated valsartan drugs, it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more. A pharmaceutical products attorney can help you navigate the complexities of this type of litigation.

If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.

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