Washington, D.C.—A new report summarized FDA data regarding consumers’ problems swallowing supplements, and found that, over the time period 2006-2015, out of 20,791 adverse event reports submitted, 3,962 indicated swallowing problems. 85.6% of those reports were from women. Only 64.5% of the reports included age data, but of those, 76.8% involved adults aged 65 or older.
As background, the report notes that FDA recommends that generic drug products not exceed 17mm in a single dimension; no tablets or capsules should exceed 22mm. Similar guidelines to not exist for dietary supplements. Multivitamins and calcium supplements were heavily implicated in the adverse events reports, being seven out of the 10 most commonly reported supplements; one particular multivitamin product marketed to older women was involved in 40.6% of swallowing problem reports. The average size of the 10 most commonly reported dietary supplements—which accounted for 76.4% of swallowing problems—was 19.3mm long, 9.8mm wide, and 7.8mm high. All exceeded 17mm in length.
The report, published in Annals of Internal Medicine, noted that the study had limitations, including possible underreporting of swallowing problems and the fact that data regarding frequency of use for specific products were not available. However, the researchers noted, the data still identified a specific harm—choking—that may be preventable.
Related: Adverse Event Reports: A Look at the Data on Dietary Supplements
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The Council for Responsible Nutrition released a statement from Andrea Wong, Ph.D., VP of scientific & regulatory affairs, which is as follows:
“At CRN, consumer safety is our top priority, and we appreciate any opportunity to remind consumers of ways to safely consume dietary supplements. Choking is preventable, and there are many reasonable solutions for consumers who may have difficulty swallowing dietary supplements, as indicated in this letter. For example, adult supplement users can talk with their pharmacist or other healthcare practitioner about modifying dosage form characteristics. Adult supplement users can also choose alternative, innovative delivery options, including liquids, gummies, melts or effervescent powders. With three quarters of Americans taking dietary supplements each year, it is important that the task of swallowing a supplement does not get in the way of consumers’ access to good nutrition. If swallowing anything – a dietary supplement, an over-the-counter or prescription drug, or food—is a struggle, we recommend consumers seek the attention of a medical professional.”