Infant Head-Shaping Pillows Can Kill Babies, FDA Says

Note to new parents and other caregivers: Babies should sleep on their backs and ditch the soft bedding — no padded crib bumpers, blankets or pillows, including those claiming to shape infant heads. All are potentially deadly, and the latter serves no medical purpose, according to federal health officials.

"The use of head-shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of of suffocation and death," the Food and Drug Administration warned on Thursday, noting that it had recently learned of companies claiming thee products can can prevent and treat so-called flat-head syndrome.

The pillows are not FDA-approved.

"Be aware that infant head shaping pillows are not safe or effective for preventing or treating flat-head syndrome or other medical conditions," the agency added. 

The products are sold nationwide by retailers including Amazon and Walmart. 

What is plagiocephaly?

The small baby pillows have indents or holes in their centers and are marketed as a means of alleviating flat-head syndrome. The issue is one that can arise when babies spend a lot of time on their backs, with flat spots developing on the back of their heads. But most cases of what's technically known as plagiocephaly, are short-lived and improve with age, according to the FDA.

The American Academy of Pediatrics began recommending back-sleeping for babies in 1994, a campaign that helped in dramatically reducing incidents of sudden infant death syndrome. The AAP also recommends that infants sleep on their backs without any soft bedding. 

Hundreds of infant deaths, and the ongoing risk of suffocation, has prompted new regulations for infant sleepers and the recall of millions of products, including rockers. 

First published on November 3, 2022 / 4:21 PM

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