It should be easier to report food issues to the FDA


What do you think of when you hear “MedWatch”? A special wristwatch that tells you when to take your meds? A TV series with doctors patrolling the beaches? A government program that collects information on food safety issues? Probably not the last, but that is, in part, what MedWatch is.

MedWatch is a program that the United States Food and Drug Administration uses to collect adverse event reports related to a wide range of products, including prescription and over-the-counter drugs, medical devices, cosmetics, food , etc. Although the name “MedWatch” may suggest that the system only addresses drug-related issues, if a consumer or healthcare professional wishes. report a problem with food, the FDA asks them to complete the same MedWatch formally designed for drugs.

The FDA uses this program to learn about unusual allergic reactions to foods, inaccurate food labels, and foods that appear to be contaminated (especially with dangerous substances, like poppy seeds contaminated with opiates). When it receives this information, the FDA will investigate the issue and may even ask the company to issue a recall.

Unfortunately, MedWatch is widely underused to report these diet-related issues. (This is also not great for drugs.) It certainly doesn’t help that the MedWatch formulary asks questions that don’t make sense when it comes to food, asking about “strength.” Product and asking, “Why did the person use the product?” These questions might prompt anyone reporting a problem with a food to wonder if it is in the right place.

CSPI researchers have been involved in several studies, the results of which indicate the need for an improved system for reporting food-related adverse events to the FDA. The last of these studies, published this month, identified 379 sesame-related adverse events reported through an online survey between October and December 2018, including 360 allergic reactions that resulted in anaphylaxis. In contrast, a search for “sesame” of the FDA’s Adverse Event Reporting System (CAERS), a public database where food-related MedWatch reports are compiled, found only one report of 2018 anaphylaxis.

Another one to study by CSPI researchers published earlier this year found that 604 adverse events involving poppy seeds were reported to poison control centers between 2000 and 2018, but only 18 adverse events involving poppy seeds were reported in CAERS during of a similar period. That’s 34 times fewer reports to the FDA than to poison control!

A third to study conducted by a team of FDA scientists, with CSPI President Dr Peter Lurie, found that between 2008 and 2015, 13,753 adverse events related to caffeinated energy drinks were reported to poison control centers, against 510 of these events reported in the CAERS. That’s 27 times fewer reports to the FDA than to poison control.

The FDA needs a better system for reporting food-related adverse events so the agency can monitor potentially serious risks, from food allergies to inadequate labeling to microbial contamination. The FDA is working on a new and improved food-specific adverse event reporting system, and the CSPI is advocating that the agency make it a priority. But until then, spread the word: MedWatch isn’t just about drugs.


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