The U.S. Food and Drug Administration is investigating several potentially cancer-causing substances, called nitrosamines, recently found in some drugs, including those used to treat elevated blood pressure, heartburn, and acid reflux. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, and nizatidine – have been recalled because of nitrosamine impurities. The FDA knows this is a concern.
Patient safety is the FDA’s top priority. We continue to work with manufacturers to investigate the source of nitrosamines in drugs and whether they are at a high enough level to pose risks to human health. The FDA and manufacturers are testing samples of certain medications that may contain nitrosamines and will continue to take quick and appropriate action when needed to protect American consumers.
So, what are nitrosamines? Nitrosamines are organic compounds that we are exposed to in our everyday lives. They exist in low levels in our water and foods, including meat, vegetables, and dairy products.
Nitrosamines come from chemical reactions and can form in drugs during manufacturing. These chemicals are scientifically called N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Some nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. People taking drugs that contain NDMA at or below the acceptable daily intake limits every day for 70 years are not expected to have an increased risk of cancer.
Here’s what to do if you’re concerned about your medication:
Continue to Take Your Medications
Don’t abruptly stop taking your prescription medications without first talking to your health care provider. Your health care professional has a more complete picture of your health and health history and can help you make the best decisions for your care.
They know about your health condition, including understanding what other drugs have worked for you or not, and can help determine the next steps if your drug has been recalled.
Consumers taking nonprescription ranitidine or nizatidine can consider using other over-the-counter (OTC) products to treat their condition.
Find Out if Your Medication Is Recalled or Affected
If you have a question about your medication or want to find out if it has been recalled, call your pharmacist or the FDA. The FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email, firstname.lastname@example.org, and by phone, 1-855-543-DRUG (3784) and 301-796-3400.
For general recall information, visit the FDA website. The FDA also has specific pages for ARBs (valsartan, losartan, and irbesartan), which are used to treat high blood pressure and heart failure – www.fda.gov/arbrecalls – and for ranitidine, commonly known as the brand-name drug Zantac, which is used to treat acid reflux – www.fda.gov/ranitidine.
If your medication is not recalled, continue to take it, and stay informed. Sign up for FDA email alerts about your medications here to get timely updates.
Some metformin diabetes medicines in other countries were reported to have low levels of NDMA, but there are no metformin recalls currently affecting the United States. The FDA will provide timely updates about any recalls to patients and health care professionals.
What to Do if Your Medication Has Been Recalled
If your medication is affected by a recall, call your pharmacy. They’ll know if the specific batch dispensed to you is part of the recall. If it was, talk to your pharmacist and health care provider to discuss your options, including switching to another medication, so that you don’t go without treatment.
The FDA encourages patients to talk to their health care professional if they have questions about their medicine, as the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines. The FDA and the international scientific community do not expect nitrosamines to cause harm when ingested at low levels.
The FDA urges patients to continue to take their medications and check with their health care professionals about alternative treatments if needed. For more information, visit these FDA pages for answers to your questions about nitrosamine impurities found in ranitidine, ARBs, and metformin.