Heart Failure Medication Recall Expanded by FDA
Have you read about the recent series of medication recalls for the heart failure and hypertension drug valsartan? If you or someone you love takes this medication, you should be paying close attention to the product recall notices and to the news coverage surrounding this dangerous drug. According to a recent report from Medscape, the recall on valsartan has expanded to include an additional 80 lots of medication that contains valsartan “because of the presence of the probable carcinogen N-nitrosodiethylamine (NDEA).” To be clear, this is not a new heart medication recall, but an expansion of a previous drug recall involving medications containing valsartan.
The latest valsartan medication recall was announced on December 31, and it “includes amlodipine valsartan tablets, valsartan hydrochlorothiazide tablets, and valsartan tablets.” These medications were distributed across the country, and nearly any U.S. consumer who uses one of these medications could be affected. Although the manufacturer, Aurobindo Pharma USA, has not indicated that any patients have reported injuries, this does not mean that valsartan-containing products could not result in patient injury if consumers continue to use the recalled drugs. As such, it is important to be aware of the information surrounding the drug recall and explore your options for a valsartan lawsuit if you or a loved one have been affected.
In related medication recall news, at the start of the New Year, the U.S. Food and Drug Administration (FDA) also reported that Torrent Pharmaceuticals has expanded a drug recall of Iosartan potassium tablets due to the presence of NDEA. The company initially recalled two lots of 100-mg tablets in late December 2018, and its expanded recall now includes 25-mg tablets, 50-mg tablets, and 100-mg tablets. Like the valsartan products, these drugs were distributed nationwide. Iosartan is used to treat hypertension (also known as high blood pressure).
The article reports that Aurobindo Pharma USA is “notifying its distributors and customers by telephone and in writing to discontinue distribution of the specific lots being recalled and to notify holders of their subaccounts.” In other words, consumers using any of the heart medications involved in the recalls are supposed to receive notice from the company. However, if recent drug recalls have taught consumers anything, it should be that consumers should not rely on product manufacturers to make sure that all dangerous products are removed from the market and that any consumers who may have purchased the products are notified promptly.
Learning More About Medication Recalls
What do you need to know about drug recalls? The FDA provides a fact sheet about recall classifications and alerting the public to recalls concerning dangerous drugs. Here is how the FDA explains medication recall classifications, which are important for consumers to understand the gravity of the recall:
- Class I: this is the most serious classification of drug recall, and it is used in situations where “a dangerous or defective product . . . could cause serious health problems or death.”
- Class II: this is the second-most serious recall classification, and it is used when drugs “might cause a temporary health problem, or pose [a] slight threat of a serious nature.”
- Class III: this is the least serious medication recall classification, and it is used for products that are “unlikely to cause any adverse health reaction,” yet the products violate “FDA labeling or manufacturing laws.”
What should you do if you are using valsartan or another recalled drug? You should contact your healthcare provider immediately to learn whether you should stop taking the drug and how you may be able to obtain a replacement medication. You should also speak with a dangerous drug lawyer about your options pertaining to a valsartan recall lawsuit.