Parents Warned To Stop Using Infant Head Shaping Pillows

By Bill Galluccio

November 4, 2022

Cute newborn baby
Photo: Getty Images

The Food and Drug Administration is advising parents to stop using infant head shaping pillows immediately because they "may contribute to the risk of suffocation and death."

The FDA said the pillows are marketed as medical devices that can be used to treat flat head syndrome or other medical conditions. They usually have an indent or hole in the center to cradle an infant's head while they sleep. However, the pillows are not FDA-approved and could actually pose a danger to sleeping infants.

"The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose," the agency said in a safety communication. "The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death."

The FDA said that any parents who have a head shaping pillow should throw it away.

Any parents concerned about the shape of their child's head should speak with their doctor about other treatment options if they are necessary.

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