Certain high blood pressure drugs were recently recalled due to some “unexpected” impurity. The U.S. Food and Drug Administration (FDA) announced voluntary recall of various drugs that contain valsartan. These drugs are generally used to treat heart failure and high blood pressure.
The drugs were recalled by FDA due to an impurity known as N-nitroso dimethylamine (NDMA). This substance is a potential carcinogen based on certain laboratory tests.
Most of companies that manufacture blood pressure drugs are now voluntarily recalling the drugs containing valsartan. These pharmaceutical companies include Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries Ltd.
The FDA explained that NDMA impurity was completely unexpected and is somehow related to certain changes in the process, the active substance was synthesized.[1]
Dr. Victoria Shin, a cardiologist, Torrance Memorial Medical Center, California explains that valsartan is not exactly the problem. A particular contaminant that somehow was produced during the manufacturing process; is the real problem. She asserts that patients must not altogether lose faith in these blood pressure drugs. She also adds that the recall would not affect the patients because other valsartan drugs are available.
The FDA is working to ensure that the United States has sufficient availability of unaffected blood pressure drugs.
What Must Patients Do Now?
The FDA has listed all the recall instructions provided by the blood pressure drugs manufacturers, including the return, disposal and the drug lot number that are being recalled.[2]
The patients should carefully look for the drug and the manufacturer to check if it is listed for FDA recall or not. They may also contact the pharmacy from where they bought those blood pressure drugs.
These drugs are generally used for treating rather serious medical conditions such as high blood pressure and a heart failure. Shin warns that patients must not stop taking this medicine, without consulting their doctor as higher and uncontrolled blood pressure may possibly lead to negative health consequences.
You doctor can also help you to find alternative blood pressure drugs. This can be any other valsartan drug or some angiotensin receptor blocker. These receptor blockers include irbesartan, losartan, Olmesartan and others.
It would be best to monitor the blood pressure closely, once you have changed your medications.
The U.S. Environmental Protection Agency (EPA) states that the NDMA is produced during both natural and industrial processes[3]. It was earlier used in the production of antioxidants, liquid rocket fuel and various lubricant additives.
The EPA states that certain laboratory studies have indicated its negative impacts on human health. Prolonged exposure to high levels of NDMA may possibly lead to liver damage.
The long-term risk of cancer due to NDMA contaminated valsartan products is still unknown.
The FDA officials are now investigating the amount of NDMA, that was present in the recalled drugs and are analyzing the effects on patients’ health who have consumed these drugs before recall.
