The blood pressure and heart failure medication valsartan has been the subject of several recalls in 2018. Three separate recalls were announced by the U.S. Food and Drug Administration (FDA) from July through the end of September because of the presence of harmful impurities. Known carcinogens were found in several lots from multiple different pharmaceutical companies. Because of those recalls, the cost of this important medication has soared, patients have been put at risk of developing cancer, and the FDA has frozen imports of the drug from China.
Valsartan Recalls and Lawsuits
The recalls began in July of this year when the FDA announced there would be a voluntary recall over the presence of NDMA in several lots of the drug. This compound is categorized as a potential human carcinogen, meaning it could cause cancer. Companies involved in the recall included Major Pharmaceuticals, Teva Pharmaceuticals, Lake Erie Medical, Proficient Rx, NuCare Pharmaceuticals, and others.
More recalls were issued in August and September because another carcinogen, NDEA, was found in multiple lots of valsartan. The FDA announced the voluntary recalls and urged patients to continue taking the drug until speaking to their doctors about an alternative.
The FDA also placed a freeze on valsartan coming from China. It was the Chinese drug manufacturer Zhejiang Huahai Pharmaceuticals that was responsible for making the tainted drug that was sold and eventually recalled from the American companies.
Because of the recalls and the risks to patients caused by the impurities in the drug, many lawsuits have already been filed against the companies responsible. Class action lawsuits in New Jersey, New York, and Missouri have begun and are seeking damages to help patients recoup costs of the drug that could put them at risk for stomach, liver, colorectal, kidney, and pancreatic cancer.
Cost of Valsartan Soaring
Valsartan is a drug that many people rely on to control blood pressure and to treat heart disease and heart failure. Unfortunately for those patients who need the drug, the recent recalls have spurred a surge in the price. Not all lots or all manufacturers of valsartan faced the need for a recall, but because there were so many involved the drug is now more difficult to get and more expensive.
Over the course of just two months, from August to October, the cost of valsartan more than doubled. One 160 milligram tablet of valsartan increased from about 14 cents to 31 cents. The lower dose tablet, with 80 milligrams of valsartan went up from 9 cents to 20 cents. The price may go back down, but for the time being patients may struggle to buy the drug the need.
FDA Continues to Test Valsartan for Impurities
Because of the harmful substances found in so many lots of valsartan the FDA is continuing to test the drug. It is also investigating similar drugs to look for dangerous impurities. The FDA will post its results as it finds them to inform physicians and consumers and to determine if more recalls need to be made in the future.
The presence of NDMA and NDEA in valsartan may have serious impacts on patients. It is possible that the impurities have been in the drugs for years, and if this is the case patients could be at risk for developing cancers. There may be cases of new cancers in patients who used valsartan in the coming years, and along with these more lawsuits against the companies responsible.