Patient safety is the FDA’s top priority. 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, acid reflux, and diabetes. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin – have been recalled because of nitrosamine impurities.
The FDA has requested manufacturers withdraw all ranitidine (brand name Zantac) products on the U.S. market. The FDA knows this is a concern.
Most recently, the FDA announced that its testing showed levels of the nitrosamine N-Nitrosodimethylamine (NDMA) in some samples of the extended release (ER) formulation of the diabetes medicine metformin that exceed the agency’s acceptable intake limit. The FDA requested that five manufacturers of those medicines voluntarily recall metformin ER with NDMA above the acceptable intake limit.
The agency is also asking all manufacturers of ER versions of metformin to evaluate their risk of excessive NDMA and to test at-risk products before each batch is released onto the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and should not release the batch to the U.S. market.
The FDA continues to work with manufacturers to investigate the source of nitrosamines in drug products and whether they are at a level that may 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 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 nizatidine can consider using other over-the-counter (OTC) products to treat their condition.
The FDA has requested that manufacturers withdraw all remaining prescription and OTC ranitidine on the U.S. market, known commonly by the brand name Zantac. This means ranitidine will not be available for new or existing prescriptions or OTC use in the U.S. Consumers should stop taking any OTC ranitidine they may currently have. Patients currently taking prescription ranitidine should contact their health care professional to discuss alternatives before they stop taking the medicine. Multiple drugs are approved for the same or similar uses as ranitidine. Consumers should dispose of any ranitidine products properly, and not buy more of it.
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 metformin, ARBs (valsartan, losartan and irbesartan), which are used to treat high blood pressure and heart failure, and for ranitidine, which is used to treat acid reflux.
If your medication is not recalled or withdrawn, continue to take it, and stay informed. Sign up for FDA email alerts about your medications here to get timely updates.
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.