What is Going on with the Valsartan Recall?

What is Going on with the Valsartan and Losartan Recalls?

As federal drug regulators scramble to address the global issue of the cancer-causing chemicals that were discovered in valsartan and its rival blood pressure medications irbesartan and losartan, lawsuits are beginning to pile up against the drug makers responsible for manufacturing the tainted drug products, and patients taking these medications are now wondering what is going on with the valsartan recall and how it affects them. If you took valsartan or another recalled “sartan” drug, and you have since suffered colorectal cancer, bladder cancer, uterine cancer, gastric cancer, liver damage or another serious side effect, contact a reputable drug injury lawyer as soon as you can to discuss your possible compensation options.

Contaminated Angiotensin II Receptor Blockers

Valsartan, the generic version of Diovan, belongs to a class of drugs that also includes irbesartan (Avapro) and losartan (Cozaar), which are commonly used to treat high blood pressure and heart failure, either on their own or in combination with other medications. These drugs, known as angiotensin II receptor blockers (ARBs), work by inhibiting a hormone in the body called angiotensin, which can cause the blood vessels to constrict and cause hypertension, or high blood pressure.

There is currently an ongoing investigation into the contamination of these valsartan drugs and the health risks they pose for patients. According to the FDA, the drugs contain carcinogenic impurities like N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), which are probable carcinogens, meaning they can cause cancer in humans. The issue with these drugs is that the generic versions were being made in labs overseas, almost exclusively by Zhejiang Huahai Pharmaceutical Co. (ZHP) of China and Hetero Labs Limited of India, and the manufacturing process the labs were using to make the drugs produced as byproducts the carcinogenic impurities NDMA, NDEA and NMBA. These impurities contaminated the blood pressure medications, which were then shipped to the United States for consumer use.

Blood Pressure Medication Recalls

There have been multiple recalls affecting hundreds of lots of valsartan, irbesartan and losartan, the first of which was announced in July 2018, after it was discovered that batches of drug products containing valsartan that were manufactured by ZHP of China were tainted with NDMA. According to reports, the tainted medications had been distributed in the United States by Teva Pharmaceutical Industries, Major Pharmaceuticals and Solco Healthcare. After the first valsartan recall, the FDA launched an investigation into the contamination and several other drug recalls followed, which affected medications distributed by Torrent Pharmaceuticals, Mylan Pharmaceuticals, Aurobindo Pharma USA, Inc., and other drug makers.

In addition to widespread valsartan recalls issued by the FDA, dozens of lawsuits have also been filed by individuals across the country who allege that contaminated valsartan, losartan and irbesartan products caused them to suffer potentially life-threatening side effects, like kidney cancer, kidney damage, liver cancer, liver damage, colorectal cancer and gastric cancer. The product liability lawsuits also allege that the drug companies knew about the potential contamination of their valsartan products for years, yet did nothing to warn patients about the potential health risk.

Drug Products Affected by Recalls

Not all blood pressure medications have been tainted with carcinogenic impurities, but as the FDA continues its investigation into the massive contamination of these drugs, additional recalls are expected. Most recently, on April 26, the FDA announced that it would be expanding its recall of the tainted blood pressure drugs for the fifth time this year. The recall announcement indicated that additional lots of losartan manufactured by Hetero Labs Limited were found to be contaminated with trace amounts of NMBA. At that time, the FDA reported that “Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.” In January, several valsartan products were recalled due to the amount of NDEA found in the valsartan active ingredient.

Nitrosamine chemicals like NDMA, NDEA and NMBA are environmental contaminants that can be found in water and certain foods, like dairy products, meats and vegetables, but their presence in medications is “not acceptable,” as the FDA states. According to the National Cancer Institute, “Some nitrosamines cause cancer in laboratory animals and may increase the risk of certain types of cancer in humans.”

Find Out if You are Eligible for Compensation

Consumers expect their medications to be reasonably safe and free from impurities that could potentially affect their health, and those who took valsartan and other tainted blood pressure medications may have grounds to file a lawsuit to pursue compensation for any harm they suffered. To date, plaintiffs have filed lawsuits against as many as 40 manufacturing companies, including ZHP of China, Mylan, Teva and a number of generic drug makers in India. In all, thousands of lawsuits are expected to be filed against the makers of generic valsartan, losartan and irbesartan products in the coming months and years. If you or a loved one has been adversely affected by a recalled valsartan drug product, do not hesitate to protect your legal rights. Contact an experienced valsartan recall attorney as soon as possible to determine whether you may be eligible to file a product liability lawsuit against the drug manufacturing company.