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FDA takes first step to protect children from medications that look and taste like candy

As children’s ER visits for accidental overdoses are on the rise, a cautionary guide for "candy-like" over-the-counter products is needed, health officials say.
Gummy vitamins
Gummy vitamins.Juanmonino / iStockphoto/Getty Images

Is that gummy a vitamin or candy? It can be hard to tell, especially for children.

Since 2019, there’s been a spike in the number of children younger than 4 who were taken to the emergency room for ingesting gummy multivitamins and over-the-counter sleep aids like melatonin.

That’s why the Food and Drug Administration convened a meeting of experts Monday to discuss what, exactly, makes a drug “candy-like.”

The experts, who included more than a dozen doctors, drugmakers and poison control center directors, noted that risks of candy-like drugs being accidentally ingested depended on taste, packaging and how the products were formulated, such as chewable gummies versus hard tablets that must be swallowed.

“I’ve heard of situations where babysitters didn’t know which are the gummies or which are the medications,” Dr. Suzanne Doyon, medical director of the Connecticut Poison Control Center and an assistant professor of emergency medicine at UConn Health in Connecticut, said during the FDA meeting.

Making over-the-counter medications more appealing to children is not inherently a bad thing. Many children’s medications don’t taste very good, so drugmakers have tweaked their products to improve the flavor so children will take them.

Some of these products, however, may become so appealing that they run the risk of children eating them like they’re candy, not drugs.

“Children will get into anything, and children will especially get into anything that tastes or looks like candy,” said Dr. Theresa Michele, who leads the FDA’s office of nonprescription drugs.

Rachel Meyers, pediatric pharmacist and professor at Rutgers University’s Ernest Mario School of Pharmacy in New Jersey, warned about medications that taste so good that children end up eating too many.

“We need to get rid of the idea that it needs to be absolutely delicious to take it,” she said.

Data presented by the Centers for Disease Control and Prevention found that the root cause of many accidental ingestions by children was the practice of adults to leave the medications outside of containers, with many children unaware if they were medications or sweet treats.

Jeffrey Worthington, the president of Senopsys, a firm that works with drug companies to make their products easier to consume, recommended removing added colors and avoiding cartoon characters or iconic shapes.

“I think there are lots of things I can point to in a gummy that I would rather not see in a drug product,” he said. “Things like rings and worms, cartoon characters and a lot of the iconography that aligns with gummies and other dietary supplements.”

Others at the meeting recommended packaging and labels to include embossing or for pills to be individually wrapped to deter overdosing.

The meeting didn’t include a vote and the FDA didn't say whether there would be further discussions.

Dr. Christopher Hoyte, medical director of the Rocky Mountain Poison & Drug Center, suggested a straightforward definition for candylike medications.

Anything “reasonable that a person would look at it and have a sort of difficult time telling the difference between the two,” he said.

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