Washington, DC—With the current COVID-19 pandemic, pharmacists should remind patients and customers that prescription and OTC ranitidine drugs should be disposed of at home and not returned to a drug take-back location, which could increase exposure risks.
Those seeking to get rid of the OTC medications can follow the specific disposal instructions in the medication guide or package insert or follow the FDA’s recommended steps, which include ways to safely dispose of these medications at home.
The FDA announced it is requesting manufacturers withdraw all prescription and OTC ranitidine drugs from the market immediately. The action is related to an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, marketed as Zantac.
Public health officials have determined that the impurity in some ranitidine products increases over time and when stored at higher-than-room-temperatures. That means consumers could be exposed to unacceptable levels of the impurity. The FDA’s response has been to make sure that ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Last summer, the FDA became aware of independent laboratory testing that found NDMA, a probable human carcinogen, in ranitidine. While low levels of NDMA, which are present in food and water, are commonly ingested in the diet, sustained higher levels of exposure might increase the risk of cancer in humans, the agency notes.
While the FDA warned of the potential risks and suggested alternatives in September, it didn’t have enough scientific evidence then to remove the products from the market.
“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” according to an agency press release.
“The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
The FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more but consider using approved OTC products.
Pharmacists should remind patients taking prescription ranitidine that they should speak with their healthcare professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.
NDMA has not been found so far in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec).
Ranitidine is not on the FDA’s so-called flush list, so the medications are advised to be mixed with an unappealing substance such as dirt, cat litter, or coffee grounds, placed in a sealed plastic bag, and thrown away in the trash at home.
The agency advises that tablets or capsules not be crushed and that all personal information on the prescription labels always be deleted before trashing or recycling.
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Those seeking to get rid of the OTC medications can follow the specific disposal instructions in the medication guide or package insert or follow the FDA’s recommended steps, which include ways to safely dispose of these medications at home.
The FDA announced it is requesting manufacturers withdraw all prescription and OTC ranitidine drugs from the market immediately. The action is related to an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, marketed as Zantac.
Public health officials have determined that the impurity in some ranitidine products increases over time and when stored at higher-than-room-temperatures. That means consumers could be exposed to unacceptable levels of the impurity. The FDA’s response has been to make sure that ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Last summer, the FDA became aware of independent laboratory testing that found NDMA, a probable human carcinogen, in ranitidine. While low levels of NDMA, which are present in food and water, are commonly ingested in the diet, sustained higher levels of exposure might increase the risk of cancer in humans, the agency notes.
While the FDA warned of the potential risks and suggested alternatives in September, it didn’t have enough scientific evidence then to remove the products from the market.
“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” according to an agency press release.
“The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
The FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more but consider using approved OTC products.
Pharmacists should remind patients taking prescription ranitidine that they should speak with their healthcare professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.
NDMA has not been found so far in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec).
Ranitidine is not on the FDA’s so-called flush list, so the medications are advised to be mixed with an unappealing substance such as dirt, cat litter, or coffee grounds, placed in a sealed plastic bag, and thrown away in the trash at home.
The agency advises that tablets or capsules not be crushed and that all personal information on the prescription labels always be deleted before trashing or recycling.
« Click here to return to Weekly News Update.
