Hello. I’m Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA. I’d like to talk to you about the ongoing recall of drugs called ARBs. You may know them as Valsartan, Losartan, or Irbesartan, or perhaps you just call them “my blood pressure medicine” or “my heart medicine.”
For over 35 years, ARBs have been helping people who have heart conditions, high blood pressure, or may be at risk of a stroke or heart attack. These medicines help control the conditions, and they don’t have a lot of terrible side effects. So, people can take them quite easily. Many of my own friends and family take these medicines.
In July, the FDA learned that some of these ARBs may contain chemicals known as nitrosamines. These chemicals can cause cancer when taken for long periods of time, even in relatively small amounts. You may have heard of the chemical names like NDEA or NDMA in connection with these ARBs. These chemicals are forms of nitrosamines. As soon as the FDA discovered that some ARBs contained nitrosamines, we moved quickly to remove them from the market. We know from all the calls we’ve received that people are worried that they might get cancer from these drugs. So, I want to talk to you about that risk for a moment.
The FDA calculated that if you took the very highest dose of one of the affected medicines over four years, and you took the medicine that was the most contaminated, the risk is an additional one case in 8,000 people. To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetimes. Here’s the reality for all of us.
We’re exposed to these nitrosamines every day in small amounts in our food, our water, and our soil. For example, low levels of nitrosamines are present in smoked foods like bacon and grilled and processed meats. They also occur naturally in fresh vegetables and water.
The risk estimate is a worst-case scenario, and in fact no one would have been exposed to that much nitrosamine from ARBs, because most batches of the drugs contained much lower levels. Nitrosamines are allowed in our food and water supply in small amounts, and we seldom give it much thought. But, they shouldn’t be in our drug supply, and the FDA is going to make sure that they are removed completely from any drug that you might take.
There have been nearly 40 recalls of ARBs since last July. This is happening as the FDA and companies continue to test medicines to make sure none of these medicines contain the nitrosamines. What can you do to be safe? Well, first, don’t stop taking your medicine! The risk of exposure to cancer is so much lower than your risk of a heart-related or other problem if you would stop your medicine.
If you think your current medicine is subject to a recall, talk to your healthcare provider or pharmacist about finding a replacement. There are many other therapeutic options that can be prescribed. Visit our website – www.fda.gov/ARBrecalls – for a list of ARB medicines that have not been recalled.
The problem is not over yet. The FDA is continuing to test all ARBs on the market to make sure they’re safe. We’ll continue to work with companies to identify affected drugs, while also ensuring that patients have the medicines they need. Finally, we’ll continue our broader investigation to find the source of the contamination and ensure that the future supply of ARBs will be safe. Thank you.