Valsartan Recalled Due to Impurity That Could Cause Cancer in Patients
When patients are prescribed a drug to treat high blood pressure or potential heart failure, they should be able to expect that the prescription medication is safe for use. After all, conditions such as high blood pressure and heart failure are extremely serious, and it is often impossible for patients who require medications to treat these conditions to simply stop taking a drug because it has been subject to a safety recall. Yet that is precisely the situation in which a recent drug product safety recall is putting patients. According to a report from CNN Health, common drugs that contain the medication valsartan have been recalled because of an “impurity in the drug that poses a potential cancer risk.”
The dangerous drug has already been subject to a product safety recall in 22 different countries after the incidence of product liability negligence was discovered. The impurity that is contained in the drug is known as N-nitrosodimethylamine (or NDMA), which is “classified as a probable human carcinogen,” according to the report. Valsartan is contained in a number of generic medicines, including some of those produced by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries. It is important to note that valsartan is a “component of other generic medicines,” and “not all medicines containing the ingredient are involved in the recall.” In other words, if you take a medication containing valsartan, your prescription drug may or may not be subject to the recall, and you should speak with your physician as soon as possible. After you discuss with a doctor, consult a drug recall lawyer if it turns out your prescription was involved in the recall.
What is the impurity in the valsartan, and how did such an example of product liability negligence happen? According to the U.S. Food and Drug Administration (FDA), researchers believe that the presence of NDMA has resulted from “changes in the way the active substance was manufactured.” In studies, NDMA has been shown to cause cancer and significant liver damage in rats.
Patients who are taking a medicine containing valsartan should not panic, and they certainly should not stop taking the medicine before speaking with a physician. However, it is a good idea to get in touch with your healthcare provider as soon as learn about alternatives if you are currently on one of the recalled drugs. You also should consider contacting a product liability lawyer to discuss your options.
Getting the Facts About Dangerous Drugs and Drug Recalls
Why are drugs recalled, and what should patients do about a recall? According to WebMD, drug recalls frequently occur for one of the following reasons pertaining to product liability negligence:
- Drug has been mislabeled;
- Drug has been packaged poorly;
- Drug has possibly been contaminated with a substance that could be harmful;
- Drug label provides the wrong information about the type of drug contained; and/or
- Manufacturing defect in the product.
In the case of the valsartan, it looks as though the drug maker will be facing claims of a manufacturing defect since the impurity is thought to occur during the process of manufacture. What should you do if you are taking a drug that has been recalled? WebMD recommends the following steps:
- Do not panic;
- Learn more about the drug recall;
- Discard the drug if you are not actively taking it;
- Contact your doctor immediately if you are still using the drug to learn about your options.
If you were injured by a dangerous drug, you should speak with a product liability lawyer about your case.