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FDA Requests Removal of Ranitidine Products (Zantac), Citing Cancer Risk

Below is a press release from the FDA published April 1, 2020.

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, 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, M.D., 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.”

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

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. 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.

With today’s announcement, 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; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care 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. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.

The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The photo pictured above is attributed to The New York Times, published in an article by Katie Thomas on April 1, 2020. Full article can be found:

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Research Opportunity

Nova Southeastern University

6100 Griffin Road, Fort Lauderdale, Florida 33314-4416

PHONE: (954) 262-7726 800-986-3223, Ext. 27726


 Participant Letter for Anonymous Surveys NSU Consent to be in a Research Study Entitled: 

Clinical Practices in Head and Neck Cancer: 

A Speech-Language Pathologist Practice Pattern Survey 

Who is doing this research study? 

The person completing this study is Ashley Geer, MS, CCC-SLP, BCS-S within the Department of Speech-Language Pathology at Nova Southeastern University. They will be helped by Mario Landera, SLP.D, CCC-SLP, BCS-S as faculty advisor. 

Why are you asking me to be in this research study? 

You are being asked to take part in this research study because you are a speech-language pathologist who is involved in the treatment of patients with head and neck cancer. 

Why is this research being done? 

The purpose of this study is to find out the current practice patterns of speech-language pathologists treating patients with head and neck cancer. 

What will I be doing if I agree to be in this research study? 

You will be taking a one-time, anonymous survey. This will take approximately 15 minutes to complete. 

Are there possible risks and discomforts to me? 

This research study involves minimal risk to you. To the best of our knowledge, the things you will be doing have no more risk of harm than you would have in everyday life. 

What happens if I do not want to be in this research study? 

You can decide not to participate in this research and it will not be held against you. You can exit the survey at any time. 

Will it cost me anything? Will I get paid for being in the study? 

There is no cost for participation in this study. Participation is voluntary and no payment will be provided. 

How will you keep my information private? 

Your responses are anonymous. Information we learn about you in this research study will be handled in a confidential manner, within the limits of the law. No personal identifying information will be collected. The data will be available to the research, the Institutional Review Board and other representatives of this institution, and any granting agencies (if applicable). All confidential data will be kept securely in a password protected file on a password protected computer. All data will be kept for a minimum 36 months from the end of the study and will be destroyed by deletion of electronic records. 

Who can I talk to about the study? 

If you have questions, you can contact Ashley Geer, MS, CCC-SLP, BCS-S at (916) 213-8604 or Mario Landera, SLP.D, CCC-SLP, BCS-S at (305) 243-9479. 

If you have questions about the study but want to talk to someone else who is not a part of the study, you can call the Nova Southeastern University Institutional Review Board (IRB) at (954) 262-5369 or toll free at 1-866-499-0790 or email at 

Do you understand and do you want to be in the study? 

If you have read the above information and voluntarily wish to participate in this research study, please follow this link: 

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Paid Research Opportunity

Living with COPD?

We are looking for adults with COPD to help us to better understand the influence of COPD on eating and drinking.

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NFOSD Presents the 2019 #IDDSIchallenge!

The National Foundation of Swallowing Disorders & the International Dysphagia Diet Standardisation Initiative Presents:

The 2019 #IDDSIchallenge!

You are invited to participate in the second annual contest showing the world how you have been creating culinary delights using the IDDSI Framework.


June 1 – June 20, 2019 = Post your creations for National Dysphagia Awareness Month

June 20 – June 26, 2019 = Vote for your Favorite Creations

June 27, 2019 = Announce the Top 3 Winners

Prizes:  3 prizes of $100 gift cards

Who can enter? Everyone! You can enter as an individual, a family, a corporation, a restaurant, a healthcare organization.

How to enter:

1. Share a photo of your culinary masterpiece with the NFOSD on Facebook or Twitter and include a written description of your IDDSI testing method(s).

2. Include #IDDSIchallenge and tag @NFOSD in your post between June 1 – June 20 (deadline is midnight GMT)

**Make sure your post is public so that we can share this!**

3. Like and share your creation on Facebook and Twitter with all of your friends!

Here’s an example:

Chef Cynthia’s Puree Waffle.
Level 4: When you hold a bite on the fork, a small amount flows through and forms a tail below the fork.

Rules and Regulations ApplyClick Here for more Information

How to win:

1. All photos will be viewed by an expert panel of judges and the top 5 entries will be selected for voting by the global audience.

2. Vote using ‘likes’ to choose the winners on Facebook and Twitter.

3. Judges will add bonus points for a creative name for your masterpiece.

Meet the Judges:  Click Here

Winners will be announced and showcased on both the IDDSI and NFOSD websites.

What is IDDSI?

The IDDSI Framework was developed to provide safety, through a standardised way of naming and describing texture modified foods and thickened liquids for people with swallowing difficulties across the lifespan.  It is a person-centred rather than profession-centred approach providing practical and validated measurement techniques to ensure that what is prepared in hospital, can reliably be prepared at home or other settings to reduce the risk of choking and aspiration. The common language of the framework can be used by persons with dysphagia, caregivers, clinicians, food service professionals and industry partners, allowing us to speak the same language the world over. Learn more at:

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Dysphagia in the News: Florida Weekly

[rescue_button colorhex=”#421c52″ url=”″ title=”Visit Site” target=”blank” class=”center” border_radius=”3px”]Read Article[/rescue_button]

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