FDA Warns Against Using Infant Head Shaping Pillows

The US Food and Drug Administration (FDA) warns against using infant head shaping pillows intended to change a baby's head shape or claim to prevent or treat any medical condition.

The agency is unaware of "any demonstrated benefit" of using infant head shaping pillows for any medical purposes, such as preventing or treating flat head syndrome or craniosynostosis.

In its safety communication issued last week, the agency said that head shaping pillows could create an unsafe sleep environment for infants and increase the risk of sudden unexpected infant death (SUID), including sudden infant death syndrome (SIDS), and suffocation and death.

Flat head syndrome, also known as positional plagiocephaly, is a flat spot either on one side or the back of a baby's head. The syndrome usually occurs when a baby sleeps with the head turned to the same side during the first months of life. Having less hair on the part of the head or the ear looking pushed may also indicate positional plagiocephaly.

The syndrome is treated by laying a baby on the stomach for longer periods of time when they are awake, changing the head positions when they sleep, and holding a baby more often.

Craniosynostosis is a condition where the developing infant's skull bones join together too early. Some types of craniosynostosis require surgery, while special medical helmets may be used to treat very mild cases.

The number of sleep-related infant deaths in the US significantly decreased following an education campaign to put babies on their backs to sleep in the 1990s. However, approximately 3,500 infants still die in their sleep annually.

The Nationwide Children's Hospital recommends practicing the ABC's of safe sleep: Babies should always sleep Alone, on their Backs, in a Crib.

The American Academy of Pediatrics (AAP) also emphasizes the need for babies to sleep on their backs, as well as on flat noninclined surfaces without soft bedding and details.

Despite the recommendations, infant head shaping pillows that typically have an indent or hole in the center to cradle the back of an infant's head while they lay face up are widely available online.