Valsartan May Cause Cancer or Liver Damage
The drug recall attorneys at McWhirter, Bellinger & Associates law firm, are reviewing potential Valsartan lawsuits. Valsartan (Diovan) is a drug prescribed by doctors for congestive heart failure and to treat high blood pressure. This medication has been known to relax blood vessels and improve blood flow. It also helps to lower high blood pressure and can prevent kidney problems, heart issues, including heart attack, and stroke.
The FDA (Food and Drug Administration) recalled the popular medication in July 2018 after it was discovered that it contained a chemical linked to cancer. The FDA was slow in recalling the drug and only did so after 22 other countries had taken it off the market.
The Problem with Valsartan
The FDA found the chemical N-nitrosodimethylamine (NDMA) in the Valsartan that had been recalled. NDMA is a known human carcinogen and may increase the risk of developing cancer in some people. In the past, scientists have used this chemical to create antioxidants, lubricants and even liquid rocket fuel. More recently, the medical science community only uses the organic chemical for research purposes. NDMA is used by the food industry in cured, smoked and cooked food products because it has no odor or taste.
NDMA is highly toxic, especially in the liver, and is known to cause cancer in lab animals. In the United States, NDMA is classified as an extremely hazardous substance and is subject to strict reporting requirements by facilities that produce, store, or use it in significant quantities.
FDA Recalls Valsartan
On July 13, 2018 the Food and Drug Administration issued a Safety Communication Warning to alert the public, patients and healthcare professionals of a voluntary recall of all products containing N-nitrosodimethylamine, including the drug Valsartan. NDMA was found in Valsartan and Valsartan hydrochlorothiazide tablets produced by three different major pharmaceutical manufacturing facilities: Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited, in India, and Zhejiang Tianyu, in China. Because of the impurities in the drug and the chemical’s probable carcinogenic effect, the FDA issued the recall of contaminated Valsartan.
The commissioner of the FDA, Dr. Scott Gottlieb, stated that the agency “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 are manufactured.”
Dr. Gottlieb also stated that: “When we identify lapses in the quality of drugs and problems with their manufacturing that have a potential to create risks to patients, we are 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, are 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.”
Janet Woodcock, The FDA’s Center for Drug Evaluation and Research spokesperson, stated that: “The presence of [N-nitrosodimethylamine (NDMA)] was unexpected and is thought to be related to changes in the way the active substance was manufactured.” “We have carefully assessed the valsartan-containing medication sold in the United States, and we have found that the valsartan sold by these specific companies does not meet are safety standards. This is why we have asked these companies to take immediate action to protect patients.”
Is Your Valsartan Affected By The Recall?
The FDA recommends that you contact your doctor or pharmacist to determine if the medication you are currently taking is affected by the recall. However, they do not recommend that you stop taking your medicine until your doctor has given you a replacement medication.
To determine if your drug has been recalled, contact your pharmacist to help identify the the manufacturer of your medication. You can also check the FDA recall list.
Potential Risk of Valsartan
Exposure to N-nitrosodimethylamine (NDMA) by taking contaminated Valsartan may increase the potential risk of liver damage and\or cancer of the liver, G.I. tract, stomach, kidney and colon. If you have taken Valsartan that had the presence of NDMA, you should speak to your doctor right away. You should also consider taking legal action against the manufacturer who marketed and sold the defective drug. There is a limited amount of time to protect your rights, so you should call our office today!
If you or a loved one has been prescribed Valsartan that has been recalled, please contact the defective drug lawyers at McWhirter, Bellinger and Associates at 888-353-5513 for a free case evaluation.
McWhirter, Bellinger and Associates has offices in Aiken, Camden, Columbia, Lexington, Newberry, Orangeburg and Sumter, South Carolina. For over 45 years we have been helping injured South Carolinians with Auto Accidents, Workers’ Compensation, Wrongful Death Cases, Medical Malpractice, Dangerous Drugs and Products and all other Personal Injury cases. It won’t cost you anything to see if we can help.