Parents should not use infant head shaping pillows to change a baby’s head shape or symmetry, the Food and Drug Administration advised on Thursday.
The agency warned that these products can create an "unsafe sleep environment" for babies and raise their "risk of suffocation and death," as well as of sudden infant death syndrome. No such products have been approved, the FDA said.
Head shaping pillows typically look like a small mat that slopes downward in the middle to an indent or hole designed to cradle the back of an infant’s head. They often resemble a misshapen donut but can come in a variety of shapes, including hearts or ovals with animal-shaped ears.
Not all such pillows are labeled as "head shaping" — some are called baby head support pillows, head cushions, flat head pillows, or anti-flat head pillows.
The National Institutes of Health and the American Academy of Pediatrics recommend that infants sleep without any pillows, toys, loose bedding or soft objects nearby. Instead, they should be on their backs in a bare crib on a flat surface.
According to the FDA, marketing claims for head shaping pillows commonly suggest that they can improve an infant’s head shape and symmetry or prevent or treat flat head syndrome. But the agency said it is not aware of any "demonstrated benefit" of the products for "any medical purpose."
Flat head syndrome, also known as positional plagiocephaly, can arise when a baby sleeps with its head on the same side during the first few months of life. This can cause a flat spot on one side or the back of the head, according to Johns Hopkins All Children’s Hospital.
In most cases, flat head syndrome goes away on its own as the infant grows and does not cause any developmental issues, the FDA said.
Johns Hopkins suggests parents who are worried about this can, however, practice more supervised tummy time with their babies, vary which direction their infant faces in the crib or hold their baby more often.
"If you own an infant head shaping pillow, throw it away; do not donate or give it to anyone else," the FDA said in its advisory.
It added: "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." (Craniosynostosis is a condition in which a baby's skull bones join together too early.)
The FDA also urged health care providers to discourage the use of infant head shaping pillows and to educate parents on the risks associated with them.