Valsartan is a blood pressure medication used by thousands of patients in Kentucky and throughout the United States. It is also used to treat patients with congestive heart failure. Until July of 2018, there were no problems reported with Valsartan and it appeared to be a fairly safe medication for blood pressure and congestive heart failure patients. That changed in July of this year.
Valsartan is an older drug and is now off-patent so there are many generic medicines on the market using the formulation. The drug was originally approved by the FDA in 1996 and had the brand name Diovan. It is currently available under both names.
Why Has Valsartan Been Recalled by the FDA?
In July, the Food and Drug Administration (FDA) issued a recall of several batches of the drug Valsartan due to problems associated with the presence of a chemical known as NDMA. The chemical NDMA has been linked to an increased risk of cancer in scientific studies. The chemical has been labeled as a probable human carcinogen by the government which means it is known and proven to cause cancer in humans.
Some levels of NDMA are thought to be safe in humans. Unfortunately, the amount of NDMA that has been found in some batches of Valsartan exceed these safe levels thereby placing the user at an increased risk of cancer as a result of ingesting the chemical in these unsafe levels. The toxins associated with NDMA can cause liver fibrosis also known as scarring of the liver and liver tumors. NDMA is an organic chemical that can be found in nature and in industrial processes. It is used in a variety of applications from fuel to lubricants. It’s dangers to humans and animals has been known for quite some time.
Cancers Linked to NDMA Exposure in Humans Include:
- Stomach cancer
- Bladder cancer
- Renal cancer
- Lung cancer
- Pancreatic cancer
- Intestinal cancer
- Colon cancer
Several companies have issued a voluntary recall of medicines containing Valsartan currently include, Major Pharmaceuticals, Solco Healthcare, and Teva. Please note that not all medicines that contain Valsartan are part of the recall or thought to contain the NDMA impurity.
The Medicines Recalled Were Tablets Sold By:
- AvKare (Teva/Actavis) and (Hetero/Camber)
- A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
- Bryant Ranch Prepack Inc. (Teva/Actavis)
- Hetero Labs (labeled as Camber Pharmaceuticals Inc.)
- H J Harkins Co., Northwind Pharmaceuticals (Teva/Actavis)
- NuCare Pharmaceuticals Inc. (Prinston/Solco)
- Preferred Pharmaceuticals Inc. (Hetero/Camber)
- Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
- Proficient Rx LP
- Remedy Repack
- Remedy Repack (Prinston/Solco)
- Remedy Repack Inc. (Hetero/Camber)
- Remedy Repack Inc. (Torrent)
- Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
- Teva Pharmaceuticals USA (labeled as Actavis)
- Torrent Pharmaceuticals Limited
The List of Recalled NDMA-Containing Drugs Continues to Grow
The FDA initially created a list of the batches that were recalled due to the possibility of being tainted with NDMA on 7-23-19, but has since updated and expanded that list several times. Here is the current list of recalled batches.
The matter of how this occurred is still being investigated. There is testing underway at both Torrent Pharmaceuticals Limited and by RemedyRepack which is repackager for Torrent. The investigation is also focusing on the Chinese company Zhejiang Huahai Pharmaceuticals which manufactures the active pharmaceutical ingredient (API) for Torrent. Other companies being investigated for the safety of their products includes: Camber Pharmaceuticals Inc., Teva Pharmaceuticals, Prinson Pharmaceuticals, A-S Medication Solutions LL, and AvKARE. It is possible more will be added to this list including:
- Bryant Ranch Prepack Inc.
- H. J. Harkins Company Inc. (this company was not originally included on either list)
- Lake Erie Medical, doing business as Quality Care Products LLC
- NuCare Pharmaceuticals Inc.
- Northwind Pharmaceuticals
- Proficient Rx
Not All Valsartan Products Have Been Recalled
While not all of the Valsartan-containing products manufactured or repackaged by these companies may contain NDMA, due to the serious risk of harm posed by NDMA, the FDA is looking into all possible contamination scenarios to warn the public.
WARNING: If you are currently taking medicines that contain Valsartan you should consult your physician before stopping the medication. This is extremely important due to the serous health conditions for which many of these medications are prescribed.
Consult With Your Doctor and An Attorney to Protect Yourself
The bottom line is this: if you are taking a blood pressure or congestive heart failure medicine that may contain Valsartan you should contact your physician immediately to discuss. You should also contact an attorney to determine your rights against the Chinese company Zhejiang Huahai Pharmaceuticals and the India company Hetero Labs Limited that may have produced certain batches of valsartan contaminated with NDMA.
Gray & White Law has a long history of successfully representing clients in Kentucky and throughout the Untied States in Injury claims against pharmaceutical companies. Please contact us today for a free consultation.