High blood pressure medicine and FDA recalls

November 13, 2019 Swedish Heart & Vascular Team

We answer common questions about the FDA’s recall of several high blood pressure medicines and how to determine if you’re at risk.

  • Certain blood pressure medicines were recalled due to possible cancer-causing ingredients.
  • Find out what to do if your medication has been recalled.

[3 MIN READ]

If you’re one of the 75 million people in the U.S. who have high blood pressure, news reports about the Food and Drug Administration’s recall of several blood pressure drugs may have you concerned for your health and confused about what to do if your medication shows up on the FDA’s recall list.

Here are the answers to some of your most pressing questions.

What medications have been recalled?

During the past year, multiple batches of prescription drugs known as angiotensin II receptor blockers, or ARBs, were recalled because they were found to contain impurities that could potentially cause cancer. The medications are commonly called valsartan, losartan or irbesartan. 

The recalls do not affect every medication that contains valsartan, losartan or irbesartan. The FDA maintains a searchable list of all recalled ARB medications. To check whether your prescription is included you’ll need the following information:

  • Manufacturer’s or labeler’s name
  • National Drug Code (NDC)
  • Lot number
  • Active ingredients

All the required information should be easily found on the medication’s label or packaging. Contact your doctor or pharmacist if you have trouble locating or identifying the information you need.

Why were they recalled?

The recalled drugs contain potential carcinogens known to cause cancer that were generated unintentionally by a chemical reaction that occurred during the manufacturing process.

The contaminants that have been identified are:

  • N-Nitrosodimethylamine (NDMA)
  • N-Nitrosodiethylamine (NDEA)
  • N-Nitroso N-Methyl 4-amino butyric acid (NMBA)

These compounds are known environmental contaminants and small amounts may also be in some dairy products, meats and water. Because of their cancer-causing properties, the FDA considers their presence in medication unacceptable.

Am I at risk?

Even if your blood pressure medication is on the recall list, there is no need to panic. The likelihood of it causing cancer is extremely small, according to the FDA. Estimates indicate that if 8,000 people took the highest dose of one of the contaminated prescriptions for four years it would result in one additional case of cancer. The recalls are a preventive measure meant to reduce even minimal risk.

What should I do if my medication is on the recall list?

Even if your high blood pressure medicine is on the recall list you should continue taking your medication. Do not stop taking any prescription medication without consulting your doctor first. In many cases you may be able to switch to a medication made by another manufacturer. If that’s not possible, discuss alternate treatment options with your doctor and pharmacist.

Take any of your unused medication to your local pharmacy to dispose of it properly and safely.

What’s being done to prevent this from happening in the future?

All of the recalled medications were made in China or India. The FDA has placed import alerts on medications containing contaminants and carcinogens to prevent further sale in the United States. The agency is also working with prescription drug manufacturers to identify and change the processes that created the issue in the first place.

Find a doctor

The Swedish cardiac care team works together to develop a treatment plan that keeps your high blood pressure under control safely. Find a doctor you can trust in our provider directory.

Working to help our patients stay #hearthealthy @swedish

Related resources

Should you use generic medication over brand name?

Lowering your blood pressure – beyond diet and exercise

How to be your own health advocate

FDA recall list: Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

This information is not intended as a substitute for professional medical care. Always follow your healthcare professional's instructions.

About the Author

The Swedish Heart & Vascular Team is committed to bringing you many years of expertise and experience to help you understand how to prevent, treat and recover from cardiovascular diseases and conditions. From tips to eating better to exercise and everything in between, our clinical experts know how to help you help your heart.

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