FDA warns parents not to use infant head-shaping pillows

The Food and Drug Administration has released a safety bulletin urging parents and caregivers not to use head-shaping pillows intended to change an infant's head shape or symmetry.

There has been no proven benefit of using these pillows for any medical purpose, and in fact, using these pillows can create an unsafe sleeping environment for infants and may increase the risk of suffocation and death, the agency warned.

Editor’s Picks

Biden signs law banning sale of crib bumpers, inclined sleepers for babies

New study could help explain sudden infant death syndrome

Safety commission warns public to stop using certain infant loungers after 2 deaths

"Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome (also known as positional plagiocephaly or deformational plagiocephaly), or the more serious condition where the developing infant's skull bones join together too early (known as craniosynostosis)," the FDA said. "Do not use infant head shaping pillows due to the risk of sudden unexpected infant death (SUID), inclusive of sudden infant death syndrome (SIDS), and suffocation and death."

The agency advised anyone who owns one of these pillows to throw it away, and not donate it or give it to anyone else.

"Be aware that, in most cases, flat head syndrome will go away on its own as an infant grows, it is not painful and it does not cause any developmental concerns," the FDA said.

"If your infant has an unusual head shape, talk to your infant's health care provider about management options," the agency added. "Know that the use of infant head shaping pillows may delay the necessary evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis."

To promote a safe sleep environment, the National Institutes of Health and the American Academy of Pediatrics recommend infants sleep on their backs in a bare crib on a firm and flat (not inclined) surface without pillows, toys, soft objects or loose bedding.

The AAP also recommends that caregivers not share a bed with infants to reduce the risk of SIDS. Instead, parents and caregivers can share the same room with a baby 6 months and under and should check on them to make sure they don't overheat while sleeping.