News about a blood pressure med cancer risk has patients and caregivers around the globe scrambling and wondering whether their medication is safe to take. In early summer 2018, word spread that Valsartan, the generic form of Diovan, may be tainted with a potentially cancer-causing agent from the manufacturer. As a result, several government agencies have issued recalls. If you or a loved one have taken Valsartan, read on for important information.
Blood Pressure Med Cancer Risk: What You Need to Know
Valsartan is a blood pressure medication commonly prescribed in the US to treat high blood pressure (hypertension) and congestive heart failure. The medication is available as Valsartan and Valsartan HCTZ, the latter also containing a diuretic. In mid-2018, a Chinese manufacturer voluntarily disclosed that its production of Valsartan may be tainted with unacceptable levels of n-nitrosodimethylamine (NDMA), a compound believed to cause cancer in humans. Later, a second Chinese manufacturer also released news of possible Valsartan contamination. As a result, government agencies around the globe have issued recalls due to the fear of the blood pressure med cancer risk.
What is NDMA and How Is It Harmful?
NDMA is a chemical that does not occur naturally but can result from certain chemical reactions or as a byproduct from the breakdown of rocket fuel. In the United States, its production and use in its pure are limited to research.
The use in the production of rocket fuel ceased after unusually high levels of the compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant. According to the Centers for Disease Control, NDMA is “very harmful to the liver of animals and humans.”
U.S. Response to Contamination of Blood Pressure Med
Agreeing with the precautions taken around the globe, on July 13, 2018, the U.S. Food and Drug Administration, has issued a voluntary recall of the tainted Valsartan. The FDA later updated and expanded the Valsartan recall to include additional Valsartan products.
Currently, the FDA is investigating whether other medications and manufacturers’ products are at risk of NDMA contamination. The investigation is ongoing. If the FDA finds unacceptable levels of NDMA in other medications, those medications may be added to the recall.
Blood Pressure Med Cancer Risk: Are You Affected?
Not all forms of Valsartan are tainted by NDMA or affected by the recalls. The recall applies to only certain distributors of Valsartan, all of which obtain the medication from the affected manufacturing plants in China.
If you take any form of Valsartan, check the prescription bottle the identification of the manufacturer. The FDA’s voluntary recall affects certain dosages of Valsartan from the following manufacturers:
- Teva Pharmaceuticals labeled as Major Pharmaceuticals
- Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC
- Teva Pharmaceuticals labeled as Actavis
- AvKARE (Teva/Actavis)
- RemedyRepack Inc. (Prinston/SOLCO)
- A-S Medication Solutions LLC Teva/Actavis & Prinston/Solco)
- Bryant Ranch Prepack Inc. (Teva/Actavis)
- H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco)
- Proficient RX LP
- Northwind Pharmaceuticals (Teva/Actavis)
- Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc.
- NuCare Pharmaceuticals Inc. (Prinston/Solco)
- Remedy RePack Inc. (Hetero/Camber)
- AvKARE (Hetero/Camber)
- Preferred Pharmaceuticals, Inc. (Hetero/Camber)
- Torrent Pharmaceuticals Limited
- Remedy RePack, Inc. (Torrent)
If your Valsartan bottle lists one of these manufacturers, look further on the FDA website for updated information on drug recalls.
If your particular medication is on a recall list, contact your medical care provider right away and ask what steps you should take. You might also contact your pharmacy to ask how to obtain a non-recalled Valsartan. If possible, save your current Valsartan medicine bottles, receipts, and prescriptions in your possession in sealed plastic bags or plastic refrigerator tubs.
The presence of NDMA in your body can be detected in blood and urine by a test, but this test is not usually available and has not been used as a test for human exposure or to predict possible health effects.
What is the FDA Doing About Blood Pressure Med Contamination?
Due to the concern for blood pressure med cancer risk, the FDA is testing samples of Valsartan to confirm the extent and amount of NDMA contamination and to help inform the FDA’s ongoing investigation. The agency has also contacted manufacturers of Valsartan not currently subject to recall to determine whether their manufacturing processes are at risk for the formation of NDMA.
Valsartan is an angiotensin II receptor blocker (ARB). The FDA is also investigating whether other types of ARBs are at risk for the presence of dangerous NDMA.
Further, the FDA is releasing a test method to help manufacturers and regulators to detect and quantify NDMA in finished drug products.
What Should You Be Doing About Blood Pressure Med Cancer Risk?
If you or a family member are taking Valsartan or Valsartan HCTZ and are worried about the blood pressure med cancer risk, contact your prescriber right away, but you may also consider contacting an attorney whose experienced can help you determine whether you might have a claim for damages. The attorneys at the Law Offices of Kelly R. Reed are caring and committed to using their experience to get the best outcome possible for you. For a free consultation, click here to complete our online contact form or call us at (304) 292-2020.