The U.S. Food and Drug Administration (FDA) announced a voluntary recall of several generic drugs containing active ingredient valsartan in July 2018. Valsartan could increase the risk of certain types of cancers and create other adverse health effects such as long-term liver damage. The ingredient found in batches of drugs most commonly used to treat hypertension, recent heart attacks and people in heart failure, could be tainted by a probable human carcinogen, N-nitrosodimethylamine (NDMA) and dangerous to anyone who takes the medication.
“We have carefully assessed the valsartan-containing medications sold in the United States, 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,” said in an FDA Safety Announcement by Dr. Janet Woodcock, director of Center for Drug Evaluation and Research at the FDA.
Wagner Reese, LLP’s Indianapolis defective drug lawyers are currently representing clients sickened or injured by generic drugs containing valsartan and are available to speak with others who were prescribed a valsartan medication and have since been diagnosed with liver damage, tumors, or cancers.
Contact us today to share your valsartan injury story. We provide free and confidential initial consultation. If you wish to discuss your case, please call (888) 204-8440.
Jason Reese Discusses Valsartan Recall
Not All Drug Makers Have Joined the FDA Valsartan Recall
Three U.S. companies that sell the generic drug have joined the recall effort. Patients should know that not all drugs containing valsartan were named in the official FDA voluntary recall. The current list of drugs containing valsartan is expected to be expanded as more defective medications may be added.
Valsartan containing medicines named in the recall:
- Valsartan by Major Pharmaceuticals
- Valsartan by Solco Healthcare
- Valsartan by Teva Pharmaceuticals Industries Ltd.
- Valsartan/Hydrochlorothiazide (HCTZ) by Solco Healthcare
- Valsartan/Hydrochlorothiazide (HCTZ) by Teva Pharmaceuticals Industries Ltd.
22 other countries had previously recalled valsartan containing products used to treat serious conditions like high blood pressure and heart failure. Use of drugs with tainted valsartan is widespread making the U.S. recall slow and difficult. While some U.S. pharmaceutical companies are communicating with distributors and customers by letter and email to arrange for return of all recalled products, it remains doubtful all persons will be reached before being impacted.
Cardiac Medicines Tainted with Dangerous Carcinogen
FDA investigators found that medications containing valsartan supplied by the Chinese company, Zhejiang Huahai Pharmaceuticals may have been exposed to N-nitrosodimethylamine’s (NDMA) carcinogenic and toxic impurities since 2012. They have been supplying these dangerous drugs to U.S. pharmaceutical companies for processing and distribution in the US market through July 2018. According to the Environmental Protection Agency (EPA), NDMA is a semi-volatile organic chemical that forms in both industrial and natural processes. The B2 (probable human) carcinogen should not be found within an active ingredient in a patient’s life-saving medication.
- NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes.
- It was formerly used in the production of liquid rocket fuel, antioxidants, additives for lubricants and softeners for copolymers.
- NDMA can also be found naturally, in trace amounts in certain foods. NDMA is released in these foods through chemical reactions during the food preparation process. For example, NDMA can be produced by grilling, browning, and salting of certain meats.
- NDMA can be unintentionally produced in and released from industrial sources through chemical reactions, such as those that involve alkylamines.
NDMA’s physical and chemical properties are most often found in manufacturing plants, tanneries, pesticide manufacturing plants, rubber and tire manufacturers, fish processing facilities, foundries, dye manufacturers, and surfactant industries.
Valsartan Medication & Known Patient Warnings
Valsartan is an active ingredient found in a number of generic drugs most commonly used to treat hypertension, heart failure, left ventricular failure, and left ventricular dysfunction following myocardial infarction. The drugs are believed to be putting consumers at risk of developing a number of life-threatening cancers because of the NDMA universal carcinogen exposure with the potential to cause sickness to almost all human organs.
Studies have specifically shown NDMA to induce tumors to form in the liver, kidney, and respiratory tract resulting in:
- Liver cancer
- Gastric cancer
- Colorectal cancer
- Kidney cancer
- Lung cancer
NMDA exposure has also been associated with non-cancerous liver damage, according to the US Department of Health and Human Services. The high level short-term and low level, long-term exposures of NMDA which cause liver issues can result in internal bleeding and death if left untreated.
Prescribing Physicians Should Be Alerted
FDA drug safety officials have alerted health care systems and medical professionals of the tainted drugs but say patients should not stop taking the recalled products without first contacting their treating physicians. Health professionals will need to prescribe a replacement drug.
According to FDA warnings, patients who show signs of the following medical issues are especially at risk:
- Hereditary angioedema
- Volume depletion
- Severe congestive heart failure (CHF)
- Hepatic or renal impairment
- Aortic stenosis
- Mitral valve stenosis
Pregnant women should talk to their doctor about taking generic drugs containing valsartan as the carcinogen laced ingredient can result in fetal toxicity, and cause injury and death to the developing fetus or newborn.
Filing a Valsartan Lawsuit & Personal Injury Claim
Wagner Reese is already representing a victim of a valsartan related injury and can help file a claim for you or your loved one as well. If you were taking any of the contaminated valsartan medications, and have experienced liver damage, tumor, cancer or other alarming health issues, our job is to seek damages for you including but not limited to:
- Past and future medical expenses to treat your injuries
- Past and future pain and suffering that results from your injuries, both physical and emotional
- Wage loss
- Financial losses experienced because of your injuries
- Punitive damages
Wagner Reese has an experienced team of product liability and medical malpractice attorneys in Indianapolis who will continue to investigate claims against manufacturers and distributors of the medications containing the active ingredient Valsartan in hopes to help consumers at risk of developing a number of life-threatening cancers or related health injuries.
Have You Been Seriously Injured by a Defective or Dangerous Medicine Containing Valsartan?
Defective medication or health product cases are complex and often leave consumers in a vulnerable place. Whether your medicine-related injuries were caused by defectively designed or manufactured drugs, by hidden side-effects, or by inadequate warnings by drug sales representatives or medical professionals, we offer a free, no-obligation consultation to help you.
Our experienced defective drug attorneys can provide you the legal support and advice you need so that you can focus on your own health and healing.
Simply give us a call today at (888) 204-8440 to schedule a free consultation or speak with us by submitting our online form and our attorneys will review your information regarding your Valsartan concerns. By filling out the contact form, you agree to receive telephone calls and text messages at the telephone number provided above (including any mobile number provided) from Wagner Reese and their third-party companies.
Note: While at this time we are not filing claims related to a Valsartan lawsuit, we are happy to retain your information during our investigation. If we are able to move forward with a lawsuit, we will contact you.
Valsartan FDA Recall Video Transcript
In July 2018, the FDA recalled a widely used medication called Valsartan amid concerns that it was contaminated with a cancer-causing chemical called NDMA. Valsartan is used to treat high blood pressure and heart failure. Twenty-two countries previously recalled the drug. Valsartan is the generic version of a drug called Diovan. Many versions of Valsartan containing medications were recalled from several different manufacturers.
Attorneys at Wagner Reese, LLP are exploring mass tort litigation against the manufacturers and distributors of Valsartan. We have compiled some questions we’ve heard frequently from those who may have been affected by the recent recall. One of the most common questions we have heard is what medications are included in the recall? It’s important to understand that not all Valsartan containing medications have been recalled, only Valsartan medication manufactured by certain companies have been included, including those from Teva Pharmaceutical, Major Pharmaceuticals, Soleco Healthcare, and others. The recall continues to be expanded as the FDA investigates. You can find a full list of recalled medication on the FDA website. Visit www.FDA.gov.
Another question we hear frequently is from those who took Valsartan wondering what should they do. We recommend contacting your pharmacist to learn if your medication has been part of the recall. You should ask your pharmacist whether any of the blood pressure medications you have taken since 2012 may have been included in the recall.
Another question we see is after those have confirmed that their medication was part of the recall, what should they do next. Do not stop taking your medication. Consult your prescribing doctor to discuss your options. Abruptly stopping Valsartan without a replacement could cause serious harm. We also recommend keeping prescription bottles and any recall notices, and of course, contact Wagner Reese for a free consultation.
Another question we hear is from those who have been diagnosed with cancer wondering could their cancer diagnosis have been due to Valsartan medication. Research shows a 1 in 8,000 chance of getting cancer about being exposed to the excessive levels of carcinogens in some Valsartan medications. Although this may not seem like a lot, this is a significant and potentially deadly risk to many thousands of patients. Toxicologists are still investigating the types of cancer that may be caused by the chemical contaminant NDMA, which could include cancers of the liver, kidney, stomach, colon, esophagus, respiratory tract, mouth, and others.
Another question we hear is those wondering whether there are other harmful effects caused by NDMA. Liver and kidney damage are being reported across the country. Consult your primary care physician to obtain appropriate testing if you have concerns regarding your liver or kidney function after taking Valsartan medications.
Does it matter how long an individual was taking Valsartan? The answer is yes. We believe that patients taking recalled Valsartan longer than 30 days warrant investigation. Patients taking Valsartan from 2012 to the present may have the strongest possibility of receiving the contaminated medication.
If you or a loved one may have been harmed by recalled Valsartan medication, contact the aggressive trial lawyers at Wagner Reese, LLP at the phone number listed on your screen. There is no fee if no recovery is made on your behalf.