Valsartan Contamination – Cancer Risk & Side Effects
Valsartan is used to treat high blood pressure and other heart conditions. It is an angiotensin II receptor blocker (ARB) medication which was originally sold under the brand name Diovan.
Valsartan has been widely available as a generic medication since 2012 but recently, many manufacturers of valsartan products have recalled most or all of their formulations due to potential contamination.
Contaminants that have been found in various batches of valsartan medications include:
- NDEA (N-Nitrosodiethylamine)
- NDMA (N-nitrosodimethylamine)
- NMBA(N-Methylnitrosobutyric acid)
All three of the possible contaminants are potential carcinogens and are used in clinical research studies to stimulate tumor growth in rats. The cancer-causing chemicals strictly regulated by the Environmental Protection Agency (EPA) or are banned for use in other industries.
Valsartan Ingredient Contamination
Multiple valsartan manufacturers have been affected by potential contamination as many drug makers use the same chemical supply companies to provide raw ingredients including active pharmaceutical ingredients (API).
Valsartan API manufactured by Hetero Labs Limited (India) and Zhejiang Huahai Pharmaceuticals (China) have been found to have one or more of the contaminants NDEA, NDMA or NMBA. Any company who uses API supplied by one of these companies has been forced to recall their valsartan and valsartan-containing products. Valsartan imports from both Zhejiang Huahai Pharmaceuticals and Hetero Labs Limited have been halted by the FDA.
The recalls have affected manufacturers in the U.S., Canada and the European Union. At least 22 national health agencies outside of the U.S., along with the U.S. Food and Drug Administration (FDA) have been involved in the ongoing safety issues and have issued a number of recalls and safety alerts.
Drug manufacturers that have been affected by recalls include:
- A-S Medication Solutions LLC
- A-S Medication Solution
- Aurobindo Pharma USA
- Bryant Rank Prepack
- Camber Pharmaceuticals
- H J Harkins Company Inc.
- Major Pharmaceuticals
- Mylan Pharmaceuticals
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals
- Preferred Pharmaceuticals
- Prinston Pharmaceutical Inc.
- Proficient Rx
- RemedyRepack Inc.
- Solco Healthcare
- Teva Pharmaceuticals
- Torrent Pharmaceuticals Limited
Contamination announcements began in July 2018 and have continued to expand with increasing number of manufacturers affected and contaminants involved. The FDA has stated that contamination may have started as early as 2012 and discovery is ongoing. Numerous recalls have been announced, however there may be product that expired prior to July 2018 which was not included in the recalls but have not been discarded by consumers.
Because so many generic formulators have been affected, some consumers have experienced shortages of valsartan-containing medications. The FDA has acted by fast-tracking approval of other generic formulations which have been shown to be manufactured from uncontaminated valsartan supplies.
While recalls initially only included valsartan (generic for Diovan), they have been expanded to include other formulations containing valsartan including combinations of valsartan/hydrochlorothiazide (generic for Diovan HCT), valsartan/amlodipine (generic for Exforge), and valsartan/hydrochlorothiazide/amlodipine (generic for Exforge HCT).
Valsartan Side Effects
Separate from concerns about cancer development due to potential contamination, valsartan may cause a number of side effects including:
- Abdominal pain
- Hypotension (low blood pressure)
- Joint pain
- Back pain
Most of these side effects are mild to moderate and may go away with time. Bothersome or persistent side effects should be reported to a health care professional. Sudden changes in health status, signs of heart attack or symptoms of other serious conditions may warrant emergency treatment.
Because valsartan is used to control blood pressure or other cardiac conditions, the medication should not be suddenly discontinued. Anyone who takes valsartan should talk to a pharmacist or health care practitioner to see if their medication is included in the recall and get a different medication, if needed.
Valsartan Cancer Risk
The potential contaminants NDEA, NDMA and NMBA are known to be carcinogens under certain conditions but the FDA has stated that the risk of cancer development from valsartan contamination is low. The agency has estimated less than 1 additional diagnosis of cancer for every 8,000 cases however lawsuits may still be expected.
People who develop certain kinds of cancer may be eligible for compensation including those with:
- Colorectal cancer
- Intestinal cancer
- Kidney cancer
- Liver cancer
- Stomach cancer
Most recall information has been announced since mid-2018, but the FDA has indicated that contamination may have occurred as early as 2012, lengthening the potential time of exposure to carcinogens for some valsartan users.
Valsartan Lawsuits and Legal Information
A number of valsartan lawsuits have already been filed including both class action and product liability lawsuits. The number of cases is expected to increase as recalls continue to increase and awareness of the events expand.
Valsartan Class Action Lawsuits
A valsartan class action lawsuit against Prinston Pharmaceutical, Huahai, Solco and Teva Pharmaceuticals was filed in August 2018 by Eric J. Erwin and on behalf of others affected by valsartan recalls. The companies have been accused of knowing the medications were potentially contaminated but continuing to sell them. The Erwin lawsuit has been consolidated with other similar cases into multidistrict litigation (MDL).
Valsartan Product Liability Lawsuits
In February 2019, several individual lawsuits, including that filed by Mr. Erwin, were consolidated into multidistrict litigation (MDL 2875) in the U.S. District Court for the District of New Jersey.
Valsartan lawsuits are currently in the beginning stages and no settlements are available yet, however past legal claims have sought compensation for:
- Medical costs including cancer treatments and other care
- Lost wages including loss of future income
- Pain and suffering both physical and emotional distress
- Punitive damages where appropriate
People who have developed cancer or have been seriously damaged by valsartan contaminated or recalled products should seek legal advice.
- FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, U.S. Food and Drug Administration 8/2018
- FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products, U.S. Food and Drug Administration 9/2018
- Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient, U.S. Food and Drug Administration 12/2018
- FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall, U.S. Food and Drug Administration 3/2019