Since July 2018, the FDA has been investigating negative side effects associated with pharmaceuticals containing the active ingredient valsartan. Their investigation began with a voluntary recall which was issued in response to the finding of the carcinogen N-Nitrosodimethylamine (NDMA). A carcinogen is a substance or exposure that can lead to cancer. In September, the FDA announced that its latest round of testing revealed a second impurity, N-Nitrosodiethylamine (NDEA). Both carcinogens are formed from a specific sequence of chemical reactions conducted in the manufacturing process.
The FDA has indicated that they found that Zhejiang Huahai Pharmaceuticals, a prominent valsartan manufacturer, knew that several batches of its valsartan products contained NDEA. Upon this discovery, the FDA began retesting the products that had already been recalled, as well as products currently marketed in America. The FDA expanded its initial recall to include five manufacturers and is working closely with global regulatory agencies to test and learn more about the effects of NDEA.
Valsartan is an oral medication that is prescribed to patients with high blood pressure. It falls within the class of medications called angiotensin II receptor antagonists. Valsartan is meant to operate with the ultimate goal of relaxing blood vessels and lowering blood pressure.
Which Valsartan Products Are Being Recalled?
The FDA has a running list of products included in the valsartan recall. They will continue to update this list as more information becomes available and more products are tested. If you have been prescribed medicine containing valsartan, the FDA advises you to continue taking your medicine and speak to your doctor. The FDA’s testing shows that not all valsartan medication contains impurities, so it is important to check this list as it will change as more testing is done.
More Information on Valsartan Recall
Earlier in October, the FDA announced a new detection method for identifying whether valsartan products contain NDMA and NDEA. Because updates on this recall are constantly occurring, the FDA has centralized a webpage that contains updates on valsartan recalls.
Many lawsuits have been filed against the manufacturers of valsartan alleging that it is linked to various forms of liver damage, tumors, and cancer due to the NDMA and NDEA. The valsartan lawsuits allege that the extent of damage depends on how long one has been exposed to its impurities. Symptoms associated with overexposure to NDMA include:
- Liver problems
Other forms of cancer suspected to be related to the exposure of valsartan medication containing NDMA and NDEA include kidney and gastric cancer. Claims relating to these injuries are currently being investigated against manufacturers and distributors included in the FDA’s recall.
If you or someone you love has developed any of the mentioned injuries after being prescribed valsartan, call (713) 932-0777 to learn more about your rights. For updates on the valsartan recall and other issues related to pharmaceutical manufacturers, check back at the Simmons and Fletcher, P.C., blog.