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Infant baby sleep

Infant head-shaping pillows can cause suffocation, FDA warns

November 3, 2022

Infant head-shaping pillows should not be used on infants because they create an unsafe sleep environment and are not effective for preventing or treating positional plagiocephaly or other medical conditions, according to the Food and Drug Administration (FDA).

The agency is reminding parents, caregivers and health care providers in a safety communication that the pillows are unapproved medical devices that contribute to the risk of suffocation and death.

Still, the pillows continue to be marketed with claims that they can prevent or improve an infant’s head shape or symmetry.

Use of the pillows also may delay the necessary evaluation and management of conditions such as positional plagiocephaly and craniosynostosis.

Head-shaping pillows typically are small with an indent or hole in the center to cradle the back of a baby’s head while the infant lays face up on his or her back. Others are rectangular with no hole or indent.

Pediatricians should continue to remind parents not to use the devices and to discard (not donate) them. Health care providers also can educate their communities about the importance of a safe sleep environment for infants and etiologies and associated management options for positional plagiocephaly.

The FDA has cleared caps, helmets or headbands for use as cranial orthosis devices intended to improve cranial symmetry or shape in infants and toddlers ages 3-18 months, with moderate to severe nonsynostotic positional plagiocephaly.

If parents or caregivers experience a problem with an infant head-shaping pillow, they should report it to the FDA and the manufacturer.



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