FDA: Issues Warning On Infant Head-Shaping Pillows

By The Chicago Times Staff

November 4, 2022

WASHINGTON –  The Food and Drug Administration released a safety bulletin Thursday  urging parents and caregivers not to use head-shaping pillows intended to change an infant’s head shape..

According to the FDA, head-shaping pillows have no proven medical benefit and can create an unsafe sleeping environment for infants and may increase the risk of suffocation and death.

“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).  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 FDA said in a statement.

The FDA added “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. If your infant has an unusual head shape, talk to your infant’s health care provider about management options. 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.”