Valsartan is a medication that has been approved by the U.S. Food and Drug Administration (FDA) for treating high blood pressure, congestive heart failure and heart attack sufferers. It’s the type of medication that blocks natural substances that constrict blood vessels. It relaxes the blood vessels and releases those substances. That results in better breathing, enhanced blood flow and less strain on the heart. One of the manufacturers of Valsartan is Zhejiang Huahai Pharmaceuticals (ZHP) in Linhai, China. As a result of an impurity issue that can cause significant health issues for users, the FDA issued voluntary recalls of numerous medications containing valsartan that were made in China. Those recalls were issued on July 18, 2018. The FDA has periodically updated the recall through August 22, 2018. Expect further FDA updates.
The NDMA Cancer Link
The impurity at issue is known as N-nitrosodimethylamine (NDMA). The NDMA is a result of a change in the manufacturing process that ZHP implemented in 2012. That’s not good news for long-term users of valsartan. Unfortunately, it didn’t get the attention of the FDA until six years later. Along with the possibility of causing liver damage, NDMA is a probable human carcinogen. It has been linked to significantly increased risks of liver, kidney and lung cancer, but it carries the potential to cause cancer in nearly all organs. Symptoms might include dizziness, fever, nausea, jaundice and an enlarged liver, along with reduced liver kidney and lung functions.
As per the FDA, NDMA is a known contaminant. It’s found in cured meats, smoked meat, grilled meat and bacon. NDMA is also used as an additive to certain lubricants, softeners and even rocket fuel. To date, a total of 22 countries have issued recall notices on medications containing valsartan.
What Should I Do?
Not all valsartan drugs have been recalled at this point in time. You’ll want to get your prescription bottle, and contact your doctor and pharmacist to find out if the specific lot that your medication came from has been recalled. That’s because not all of them have the NDMA contamination.
There are plenty of other substitute medications that contain valsartan that haven’t been contaminated. Some pharmacies are even sending their valsartan customers letters about the valsartan recall. If you receive such a letter, save it along with your prescription bottle and medication.
The FDA is Now Following Valsartan Closely
The FDA has continued its investigation and research in connection with Valsartan and NDMA contamination. The agency is also studying the effects of the medication on people who have been using it. In its efforts to reduce or rid NDMA contamination from future shipments of Valsartan, the manufacturing process for the medication is also being reviewed. Dr. Scott Gottleib is the commissioner of the FDA. He remarked that “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 were manufactured.” Dr. Gottleib also stated that “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek 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.”
Contact a Louisville Personal Injury Lawyer.
We expect that the first valsartan lawsuits will be filed soon. We’ll be monitoring them closely. If you live in or around Louisville or anywhere else in Kentucky and you or a family member have been diagnosed with any form of cancer while taking valsartan, contact our offices to arrange for a free consultation and case evaluation We’re going to listen to you closely. If we believe that we might be able to move forward with a lawsuit, we’ll advise you accordingly.