The U.S. Food and Drug Agency says that it has found another unexpected impurity in three lots of the drug Valsartan, made by Torrent Pharmaceuticals. In July, the drug was first recalled due an impurity, N-nitrosodimethylamine (NDMA), which was found in recalled products. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on laboratory results. The FDA began to review the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what steps can be taken by Torrent to eliminate the impurity from future batches.
On September 14, 2018, CNN reported that “the FDA said that three lots of the drugs made by Torrent Pharmaceuticals were contaminated with a second impurity, N-Nitrosodiethylamine, or NDEA, which is also a suspected carcinogen. The agency began testing the recalled products and the pills that have no been recalled for the substance after it learned that Zhejiang Huahai Pharmaceuticals found NDEA in several batches of its Valsartan active ingredient. Not all batches have been found to be contaminated.”
If you are a patient who takes Valsartan, it is encouraged that you speak to your doctor about whether your drug is on the recall list before changing a routine with your medicine. Not all Valsartan drugs have been recalled, and your physician may be able to switch you to a version of the drug made by another company. Millions of Americans take some form of blood-pressure medication containing Valsartan, and it is unknown the exact amount of patients that could be affected by this contamination.
Potential injuries as a result of Valsartan contamination:
- Liver damage
Potential symptoms of NDMA over-exposure:
- Abdominal cramps
- Enlarged liver
- Reduced function of liver, kidneys and lungs
If you or a loved one has sustained an injury as a result of a Valsartan drug impurity, please contact the attorneys at Montgomery & Ponder, LLC immediately at (205) 377-5004.