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U.S. FOOD AND DRUG ADMINISTRATION
FDA Urges Withdrawal of All Ranitidine Products Zantac from Market
FDA Advises Public Following New Studies Highlighting Public Health Risks
April 01, 2020
FOR IMMEDIATE RELEASE:
The United States Food and Drug Administration has announced it is requesting immediate withdrawal of all prescription and over-the-counter ranitidine drugs commonly known as Zantac from the market. This action follows recent investigations by our agency into a contaminant called N-Nitrosodimethylamine NDMA, which was found in some ranitidine medications, rsing concerns for public health safety.
The FDA has determined that the NDMA impurity in certn ranitidine products increases over time and under conditions such as higher than room temperatures. This may result in unacceptable levels of exposure to consumers leading to potential health risks. Consequently, we have decided to request manufacturers to remove these products from distribution immediately. As a result of this urgent market withdrawal initiative, ranitidine drugs will no longer be avlable for new or existing prescriptions or OTC use within the United States.
The FDA is committed to ensuring that medicines provided to Americans are both safe and effective, sd Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at FDA. We strive to provide informed recommations based on the best avlable scientific evidence while taking every effort to investigate potential health risks in our medicines.
NDMA has been identified as a probable carcinogen a substance that could lead to cancer. In summer 2019, we became aware of indepent laboratory findings suggesting NDMA presence in ranitidine. While low levels are commonly present in dietary intake and water sources, these would not be expected to pose an increase in risk for cancer. However, continuous exposure to elevated levels might potentially increase the risk.
Following new FDA investigations prompted by third-party data on NDMA, we confirmed that this impurity increases even under normal storage conditions and is found to rise significantly when the product experiences temperatures higher than room temperature - such as during distribution and handling by consumers. The testing revealed that older ranitidine products or those with a longer manufacturing age have higher levels of NDMA.
In response to today's announcement, we are sing letters to all manufacturers requesting immediate withdrawal of their ranitidine products from the market. We also advise public consumption of OTC ranitidine by asking individuals to stop using any tablets or liquid they currently possess and properly dispose them, while recomming alternative treatment options such as other approved OTC medications.
As for prescription users, patients should discuss with their healthcare professionals about alternative treatments before discontinuing use of ranitidine products. To date, FDA's testing has not identified NDMA in famotidine Pepcid, cimetidine Tagamet, or products contning electronic radiation and regulated tobacco products.
This action by the FDA is a crucial step to ensure public health safety. We encourage both healthcare professionals and patients to report adverse reactions or quality issues with drugs through MedWatch Adverse Event Reporting:
Online at www.fda.govmedwatchreport.htm
Download and complete the form for submission via fax at 1-800-FDA-0178
The FDA, part of the U.S. Department of Health and Services, safeguards public health by ensuring the safety, effectiveness, and security of drugs, vaccines, medical devices, food supplies, cosmetics, dietary supplements, electronic radiation-emitting products, and tobacco products.
Contact Information for Inquiries:
Sarah Peddicord
FDA Office of Public Affrs
Phone: 301-796-2805
Consumer Hotline:
1-888-INFO-FDA 1-888-463-6332
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FDA Urges Withdrawal of Zantac Products Ranitidine Contaminant NDMA Risk Public Health Risks in Medicines Immediate Market Withdrawal Requested Alternative Treatment Options Suggested FDAs Commitment to Consumer Safety