Swallowing Problems and Dietary Supplements: Data From U.S. Food and Drug Administration Adverse Event Reports, 2006–2015

Abstract

Letters19 November 2019Swallowing Problems and Dietary Supplements: Data From U.S. Food and Drug Administration Adverse Event Reports, 2006–2015Cecile Punzalan, MD, MPH, Daniel S. Budnitz, MD, MPH, Stuart J. Chirtel, MStat, MSc, Andrew I. Geller, MD, Olivia E. Jones, MPH, Robert P. Mozersky, DO, and Beverly Wolpert, PhD, MSCecile Punzalan, MD, MPHU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Daniel S. Budnitz, MD, MPHCenters for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.), Stuart J. Chirtel, MStat, MScU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Andrew I. Geller, MDCenters for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.), Olivia E. Jones, MPHU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Robert P. Mozersky, DOU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), and Beverly Wolpert, PhD, MSU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-0947 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: To facilitate swallowing of medications and promote patient adherence to medical treatment, the U.S. Food and Drug Administration (FDA) has provided voluntary guidance regarding the size of generic drug tablets and capsules (1). The FDA recommends that generic products not exceed 17 mm in a single dimension. If a branded product already exceeds 17 mm, then the generic product should be no larger. No tablets or capsules should exceed 22 mm. Currently, similar guidelines do not exist for dietary supplements; however, these products have been implicated in swallowing problems, particularly among adults aged 65 years and older (2).Objective: ...References1. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance Document. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015. Accessed at www.fda.gov/downloads/drugs/guidances/ucm377938.pdf on 31 May 2019. Google Scholar2. Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med. 2015;373:1531-40. [PMID: 26465986] doi:10.1056/NEJMsa1504267 CrossrefMedlineGoogle Scholar3. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. CFSAN Adverse Event Reporting System (CAERS). Accessed at www.fda.gov/food/complianceenforcement/ucm494015.htm on 31 May 2019. Google Scholar4. Dietary Supplement Health and Education Act of 1994. Pub L 103-417, 108 Stat 4325 (1994). Accessed at www.congress.gov/bill/103rd-congress/senate-bill/784 on 5 August 2019. Google Scholar5. Qato DM, Wilder J, Schumm LP, et al. Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016;176:473-82. [PMID: 26998708] doi:10.1001/jamainternmed.2015.8581 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: U.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.)Centers for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.)Disclaimer: The findings and conclusions in this study are those of the authors and do not necessarily represent the official position of the FDA, the U.S. Centers for Disease Control and Prevention, or the U.S. Department of Health and Human Services.Acknowledgment: The authors thank William R. Mindak, BS, formerly of the FDA and now head of Mindak Professional Services, Springfield, Virginia, for his assistance in measuring the pill samples. Mr. Mindak was not compensated for his assistance. The authors also thank Travis Canida, BS, and John Ihrie, MStat, MSPS,Indiana University School of Medicine of the Center for Food Safety and Applied Nutrition FDA Biostatistics and Bioinformatics Staff for estimating the proportional reporting ratios.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0947.>Reproducible Research Statement: Study protocol: Available from Dr. Punzalan (e-mail, Cecile.[email protected]hhs.gov). Statistical code: Available from Dr. Punzalan, Mr. Chirtel (e-mail, Stuart.[email protected]hhs.gov), or Mr. Canida (e-mail, Travis.[email protected]hhs.gov). Data set: Available with legally required redactions at www.fda.gov/food/compliance-enforcement-food/cfsan-adverse-event-reporting-system-caers. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byIdentifying elements of a ready-to-eat meal desired by older adultsEffect of the rheological properties of the liquid carrier on the in vitro swallowing of solid oral dosage formsAre Medication Swallowing Lubricants Suitable for Use in Dysphagia? Consistency, Viscosity, Texture, and Application of the International Dysphagia Diet Standardization Initiative (IDDSI) FrameworkOsteoporosis: evidence for vitamin D and calcium in older peoplePreventing Lethal Prostate Cancer with Diet, Supplements, and Rx: Heart Healthy Continues to Be Prostate Healthy and "First Do No Harm" Part IIMultivitamin pill aspiration leading to hemorrhagic bronchial necrosis 19 November 2019Volume 171, Issue 10Page: 771-773KeywordsAdverse eventsCalciumDysphagiaElderlyFoodFood and Drug AdministrationNutritionSafetySerious adverse eventsSwallowing ePublished: 20 August 2019 Issue Published: 19 November 2019 PDF downloadLoading ...