According to a warning letter published by the U.S. Food and Drug Administration, parents and child caregivers should stop using “infant head-shaping pillows” due to potential suffocation risks. Infant head-shaping pillows are designed to alter an infant’s head shape or treat “flat head syndrome,” the U.S. Food and Drug Administration warned last Thursday. According to U.K.’s National Health Service, Flat Head Syndrome (Plagiocephaly) is a common issue for infants since they typically sleep on their backs, and their skulls are still relatively soft.
The U.S. Food and Drug Administration warned that the use of infant head-shaping pillows could create a dangerous sleep environment for babies and can lead to suffocation and death. Moreover, the U.S. Food and Drug Administration’s press release describes these pillows as having an “indent or hole in the center” that cradles a baby’s head while they are sleeping on their back, which is not FDA-approved.
In its warning letter, the U.S. Food and Drug Administration states that the agency is unaware of any demonstrated medical benefits “infant head-shaping pillows” provide to infants. However, the U.S. Food and Drug Administration believes that using head-shaping pillows produces an unsafe sleep environment for babies and creates a “risk of suffocation and death.”
According to the U.S. Food and Drug Administration’s media release, flat head syndrome normally corrects itself over time, is not painful for newborns, and will not cause developmental issues. The agency urges parents and child caregivers to throw the infant head-shaping pillows in the garbage and to never give the pillows away due to the life-threatening risks associated with the infant pillows.
The U.S. Food and Drug Administration is also asking healthcare providers to discourage parents from using infant head-shaping pillows and explain the pillow’s risk of infant death. The FDA is also asking healthcare providers to discuss how to create safe sleeping environments for infant children and educate patients about safer treatment options for flat head syndrome.
Should parents notice their baby has an unusual head shape, they should contact their healthcare provider. The U.S. Food and Drug Administration has approved headbands, helmets, and caps as flat head syndrome treatment options.
The U.S. Food and Drug Administration also warns parents and caregivers that infant head-shaping pillows may also delay the necessary diagnosis and treatment of other more serious medical conditions such as craniosynostosis. Craniosynostosis is a medical condition where a developing newborn’s skull bones converge too early.
According to the American Academy of Pediatrics website, Sudden Unexpected Infant Death (SUID) and Sudden Infant Death Syndrome (SIDS) is the number one cause of infant fatalities. The American Academy of Pediatrics believes that following safe sleep guidance will prevent a lot of SUID incidents.
The National Institutes of Health recommends creating a safe sleeping environment for babies, including having babies sleep on their backs, on a firm, level sleep surface. They also recommend that babies sleep in a wearable blanket, and the sleep space should be free of blankets, toys, or other items.
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