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Rethinking Medication Intake for Those with Pill Dysphagia

Disclaimer: Although the following article references specific brand-name products, the National Foundation of Swallowing Disorders does not endorse or promote any particular brands. Individuals with dysphagia should always consult their healthcare providers prior to using any new products or interventions.

Pill dysphagia or difficulty swallowing tablets or capsules is more common than many realize, affecting up to 40% of the general population and up to 80% in nursing homes and skilled nursing facilities (Schiele et al., 2013). Clinically known as Medication Intake Problems (M.I.P.), this condition can have physical, neurological, or psychological origins (Radhakrishnan et al., 2021). Despite its prevalence, it remains underrecognized and often mismanaged. Current mitigation strategies such as crushing pills or mixing them with food may seem practical, but they frequently compromise medication safety and effectiveness (Koziolek et al., 2019).

Crushing pills, a commonly used workaround, often alters a medication’s effectiveness and can even cause harm (Burridge, 2015). Extended-release tablets, for instance, are designed to dissolve slowly. When crushed, they can deliver their full dose all at once. This is known as “dose dumping” which can lead to an accidental overdose. Other medications can lose stability when crushed, leading to reduced efficacy (Burridge, 2015).

Crushing pills with an enteric coating destroys that protective layer, exposing both the drug and the digestive tract to risks. Without the coating, medications can degrade prematurely or become inactive in the stomach acid, and the exposed drug can irritate the esophagus and stomach lining, leading to ulcers and drug-induced esophagitis (Adams et al., 2024). Moreover, caregivers tasked with crushing pills face exposure to harmful dust and increased physical strain, making this method unsafe for both patient and provider.

Some patients attempt to mask pills in fruit products like juice or applesauce, but this, too, can lead to unpredictable medication interactions. Grapefruit juice is well-documented for increasing the amount of the active ingredient absorbed of certain medications by 2–3 times, potentially leading to toxicity (Bailey, 2010). On the flip side, apple and orange juice can drastically reduce drug absorption. For instance, when the beta blocker Celiprolol was taken with orange juice, only 20% of the active ingredient remained bioavailable – an 80% loss (Lilja et al., 2004). These interactions are due to bioflavonoids in fruit that block medication absorption, with effects that can last up to four hours post-ingestion.

Dairy products like yogurt and pudding are often used to help swallow pills but also interfere with drug absorption. Casein, a protein in dairy, can bind to medications, rendering them ineffective. One study found that up to 60% of acetaminophen’s active ingredient was lost when taken with yogurt (Carson, Pardoe, Robertson, & Glass, 2011). Additionally, calcium and magnesium present in dairy can block medication uptake, and the lack of lubrication from thick dairy products can result in pills getting stuck in the esophagus, increasing the risk of ulcers.

Thickened liquids, commonly used in dysphagia management, present their own problems. While they may help prevent aspiration, they may also slow drug dissolution and disintegration. Only 40% of a standard acetaminophen tablet was dissolved after an hour when taken with a thickened liquid (Cichero, 2013). Drugs in BCS Classes I and III, such as beta blockers, metformin, and gabapentin, demonstrate significantly reduced bioavailability when combined with these agents. The ionic charge of thickening agents also negatively impacts the medication’s release and overall effectiveness.

There are few solutions available to help individuals safely and effectively take their medications, especially for those who struggle with pill swallowing (pill dysphagia). These solutions range from alternative formulations to swallowing aids. This following paragraphs will focus on one solution that is specifically designed to improve safety and ease of swallowing pills — Gloup.

Gloup is a purpose-designed swallowing gel, offers a safer and scientifically validated alternative. Made from sea algae and available in various flavors and IDDSI thickness levels, Gloup is bioequivalent to water and remains cohesive until reaching the stomach, where it breaks down quickly due to pH and temperature. It encapsulates medication to facilitate swallowing without impacting absorption. Studies show it can eliminate the need for pill crushing in up to 40% of cases. Gloup leaves no residue in the mouth, improving oral hygiene, and most importantly, it has no known drug interactions unlike food-based alternatives.

Gloup is a cost-effective solution as well, priced at only $0.39 per intake, making it more affordable than the common but less safe alternatives of applesauce, pudding, yogurt, and thickened liquids. With a shelf life of 60 days and no need for refrigeration, Gloup may be an option for some individuals to more safely and effectively swallow pills.

By offering a solution rooted in clinical science, Gloup shifts the standard of care for individuals with pill dysphagia. As the significant risks associated with traditional compensatory methods for medication intake are better understood, the case for adopting safer, evidence-based practices becomes increasingly compelling.

For more information on Gloup, visit www.pillswallowgel.com.

References:

Adams, R., et al. (2024). The psychological impacts of pill dysphagia: A mixed methods study. Dysphagia, 39(6), 1202–1212. https://doi.org/10.1007/s00455-024-10703-4
Bailey, D. G. (2010). Fruit juice inhibition of uptake transport: A new type of food-drug interaction. British Journal of Clinical Pharmacology, 70(5), 645–655. https://doi.org/10.1111/j.1365-2125.2010.03722.x

Burridge, N. (Ed.). (2015). Australian Don’t Rush to Crush Handbook: Therapeutic options for people unable to swallow solid oral medicines (2nd ed.). Society of Hospital Pharmacists of Australia.


Cichero, J. A. Y. (2013). Thickening agents used for dysphagia management: Effect on bioavailability of water, medication and feelings of satiety. Nutrition Journal, 12, Article 54. https://doi.org/10.1186/1475-2891-12-54


Carson, S., Pardoe, E., Robertson, S., & Glass, B. (2011, March). Implications of crushing paracetamol tablets prior to administration in yoghurt to elderly patients: Is there a dilemma? Paper presented at the Medication Safety for Older People meeting, Adelaide. Retrieved from https://propartner.se/wp-content/uploads/2016/05/Sue-Carson-Paracetamol-yoghurt-4.pdf

Koziolek, M., Alcaro, S., Augustijns, P., Basit, A. W., Grimm, M., Hens, B., Hoad, C. L., Jedamzik, P., Madla, C. M., Maliepaard, M., Marciani, L., Maruca, A., Parrott, N., Pávek, P., Porter, C. J. H., Reppas, C., van Riet-Nales, D., Rubbens, J., Statelova, M., Trevaskis, N. L., Valentová, K., Vertzoni, M., Vitali Čepo, D., & Corsetti, M. (2019). The mechanisms of pharmacokinetic food-drug interactions: A perspective from the UNGAP group. European Journal of Pharmaceutical Sciences, 134, 31–59. https://doi.org/10.1016/j.ejps.2019.04.003


Lilja, J. J., Juntti-Patinen, L., & Neuvonen, P. J. (2004). Orange juice substantially reduces the bioavailability of the beta-adrenergic-blocking agent celiprolol. Clinical Pharmacology & Therapeutics, 75(3), 184–190. https://doi.org/10.1016/j.clpt.2003.11.002


Radhakrishnan, C., Sefidani Forough, A., Cichero, J. A. Y., Smyth, H. E., Raidhan, A., Nissen, L. M., & Steadman, K. J. (2021). A difficult pill to swallow: An investigation of the factors associated with medication swallowing difficulties. Patient Preference and Adherence, 15, 29–40. https://doi.org/10.2147/PPA.S277238


Schiele, J. T., Quinzler, R., Klimm, H. D., Pruszydlo, M. G., & Haefeli, W. E. (2013). Difficulties swallowing solid oral dosage forms in a general practice population: Prevalence, causes, and relationship to dosage forms. European Journal of Clinical Pharmacology, 69, 937–948. https://doi.org/10.1007/s00228-012-1417-0



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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: https://www.nytimes.com/2020/04/01/health/zantac-cancer-fda.html



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Real Science; Real Hope! – Adult Stem Cell Human Tongue Infusion Initiative Moves into the Lab (update 2)

 

Pictured at left: Myoblasts (muscle) cells under high power magnification growing in culture.

On March 9th and 29th, we published two articles about a ground breaking swallowing treatment initiative to infuse adult stem cells into a human tongue by Christmas day 2014. The high level project hypothesis is that by increasing muscle mass in a human tongue by way of an adult human stem cell infusion, this will create a stronger tongue resulting in an improved swallowing function.  This article summarizes the work to date taking place at the Institute for Regenerative Cures (IRC) at the University of California Davis Campus.

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Real Science; Real Hope! – Adult Stem Cell Human Tongue Infusion Initiative (Update)

On March 9, 2013 we published an article on a ground breaking swallowing treatment initiative to infuse adult stem cells into a human tongue by Christmas day 2014. [Click here to view that article].

Two days later, on March 11, 2013, we received an “A List” tour of the UC Davis Institute for Regenerative Cures (IRC). The NFOSD would like to thank our hosts Dr. Peter Belafsky (Phase I trial Principal Investigator), Dr. Jan Nolta (IRC director), Gerhard Bauer (Director of Good Manufacturing Practices), and Jane McClusky (tour facilitator extraordinaire).

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Breaking News – UC Davis (UCD) Launches Human Tongue Stem Cell Initiative

Stem cell initiative imageUC Davis (Sacramento), March 9, 2013 – Researchers at this University of California campus have announced plans to develop a clinical trial where they would infuse adult human stem cells into the tongues of a small set of swallowing impaired patients by Christmas day 2014. Although stem cells have been used successfully in the treatment and repair of other human organs and tissue, this will be the first step in a process to strengthen and restore a vital part of one’s swallowing function.

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