The Food and Drug Administration on Thursday released a warning to parents to not use infant head-shaping pillows to prevent or treat any medical conditions.
In a news release, the FDA suggested that parents and caregivers not use infant head-shaping pillows that could change the infant’s head shape or symmetry or claim to prevent or treat any medical condition. This is because the head-shaping pillows can create an “unsafe sleep environment,” possibly contributing to the risk of suffocation and death.
“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 in the news release. “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.”
The FDA said that infant head-shaping pillows are not FDA-approved.
According to Good Morning America, there is no proven benefit of using these kinds of pillows.
“Recently, the FDA became aware of companies marketing infant head shaping pillows with claims for the prevention and treatment of flat head syndrome without FDA clearance or approval. The FDA has communicated our concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these medical devices,” the FDA said.
To learn more about a safe sleep environment for infants, visit the FDA’s recommendations on their website.
According to GMA, the National Institutes of Health and the American Academy of Pediatrics recommend that infants sleep on their backs in a “bare crib on a firm and flat” surface with no pillows, toys, loose bedding or soft objects. It is also recommended that parents and caregivers do not share a bed with infants. Parents and caregivers can instead share the same room with a baby six months and younger to check on them.
If you experience adverse events with using an infant head-shaping pillow, file a voluntary report through MedWatch. Provide a device or brand name, manufacturer’s name, details on the adverse event and medical and/or surgical interventions if they apply.
Any questions can be emailed to the Division of Industry and Consumer Education at Dice@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
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