Defense Health Agency Ask Beneficiaries To Stop Zantac Use

Defense Health Agency Ask Beneficiaries To Stop Zantac Use

Introduction

On Monday, Defense Health Agency (DHA) officials, who manage Tricare, warned military beneficiaries to stop the use of the over-the-counter version of Zantac, as the heartburn medications might contain high levels of N-nitrosodimethylamin (NDMA), a probable human carcinogen.

Recently, on April 1, the Food and Drug Administration ordered all the manufacturers of Zantac to withdraw all prescription and over-the-counter ranitidine products, stating that the levels of NDMA increase over time, and when stored at higher than room temperatures.

Last September, several manufacturers of generic ranitidine, including Novartis and Apotex, voluntarily recalled their products sold in the U.S. Three weeks later, Sanofi also issued a recall of its products.

In the April 1 announcement, FDA officials stated that they did not observe unacceptable levels of NDMA in the samples of ranitidine they tested. However, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research stated that since they are unsure about the product storage, they have decided that this heartburn drug should not be available to consumers and patients unless its quality can be assured. 
DHA officials said patients should follow FDA advice, speaking with doctors before stopping prescription versions of the medication and disposing of all versions of the drug. 

The FDA has advised consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more. Patients who wish to continue treating their condition should consider using other approved over-the-counter products, the FDA has stated in its statement. 

The FDA has also recommended consumers some guidelines for the disposal of heartburn drugs. Consumers who wish to dispose of Zantac should mix uncrushed pills or liquids with an unappealing substance, such as dirt, cat litter, or used coffee grounds.

The public was not aware of the high levels of NDMA produced by Zantac until September 2019. An independent pharmacy, Valisure, conducted testing on Zantac, which claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA. The testing by Valisure indicated that 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, contrary to 96 ng set by the FDA.

Considering the facts about Zantac, the FDA has requested to recall all the Zantac products from the U.S. drug market. In the ongoing investigation of Zantac to check the contamination level of N-Nitrosodimethylamine (NDMA) in this drug used for preventing ulcer.

FDA has determined that Zantac, technically known as ranitidine has shown the result of an increase in impurity over time and when kept at a high temperature. Due to the request by the FDA for immediate market withdrawal of this drug used for heartburn treatment., Zantac will now not be available for prescriptions or over-the-counter usage.

The U.S. Food & Drug Administrations (FDA) posted a recall notice on its website following which American Health Packaging recalled ranitidine tablets, as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

After this, the mixture should be placed in a container, such as a sealable plastic bag. Then the container should be thrown away in a bag after removal of all personal information on the prescription labels of empty medication bottles or packaging and recycling.

DHA officials have asked the patients to follow the FDA's advice to dispose of all versions of the drug and speak with their doctors to switch prescriptions.