Don’t use infant head shaping pillows, FDA warns


Parents and caregivers should not use infant head-shaping pillows meant to change an infant’s head shape or that claim to treat a medical condition, the US Food and Drug Administration said Thursday.

“The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death,” the FDA said in a news release.

The FDA’s statement clarifies that the pillows, created with an “indent or hole in the center” to cradle an infant’s head while they sleep on their back, are not FDA-approved.

“The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose,” the agency said in a statement. “The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.”

Infant head-shaping pillows are intended to treat or prevent flat head syndrome, or plagiocephaly, a common problem for babies because they spend a lot of time sleeping on their backs, the UK’s National Health Service says.

The FDA news release explains that flat head syndrome typically goes away on its own, it is not painful for infants, and does not cause any developmental concern.

“If you own an infant head shaping pillow, throw it away; do not donate or give it to anyone else,” the agency said.

For health care providers, the FDA recommends they discourage the use of infant head shaping pillows, and ensure that patients understand the risk of infant death with use. The FDA advises health care providers to promote awareness of safe sleeping environments, and educate patients about safe treatment options for flat head syndrome.

If parents do notice unusual head shape in infants, they should seek advice from their healthcare provider. Helmets, headbands and caps are FDA-cleared options that health care providers can offer to treat flat head syndrome.

According to the FDA, using infant head shaping pillows could delay necessary evaluation and treatment – not just for flat head syndrome, but for more serious conditions as well, such as craniosynostosis, where a developing infant’s skull bones join together too early.

Infant head shaping pillows are easily available, and found at many major infant retailers according to Dr. Sarah Schaffer, pediatrician at the National Children’s Hospital.

“Hopefully this recommendation will lead to their removal from these websites,”Schaffer said.

“Sudden Unexpected Infant Death (SUID), which includes Sudden Infant Death Syndrome (SIDS), is the leading cause of injury death in infancy,” said the American Academy of Pediatrics on their website. “Sleep is a big challenge for families with babies, but following safe sleep recommendations can prevent many SUID fatalities.”

To create a safe sleeping environment, infants should sleep on their backs in a wearable blanket on a firm, level sleep surface according to the National Institutes of Health. There should be no toys, blankets, or other items in their sleeping area.

“Do not use any pillow or head shaping device that did not come in the box with your baby gear,” Schaffer said, noting that car seat attachments are also unsafe.


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