Toddler head-shaping pillows are ineffective and harmful to child, FDA warns

Toddler head-shaping pillows are usually not permitted by the U.S. Meals and Drug Administration and shouldn’t be used, the company warned Thursday.

The pillows can create an unsafe sleep setting for infants, doubtlessly contributing to the danger of suffocation and dying.

Marketed as altering an toddler’s head form or symmetry or claiming to deal with different medical circumstances, they haven’t any demonstrated profit, the company mentioned in a information launch.

“Should you personal an toddler head-shaping pillow, throw it away; don’t donate or give it to anybody else,” the alert mentioned. “Bear in mind that toddler head shaping pillows are usually not protected or efficient for stopping or treating flat head syndrome or different medical circumstances.”

Usually, flat head syndrome will go away by itself as an toddler grows up, the FDA mentioned. It isn’t painful and it doesn’t trigger any developmental considerations. Utilizing a head-shaping pillow could delay vital medical evaluations and masks one thing extra severe, reminiscent of craniosynostosis, the place a growing toddler’s cranium bones be a part of collectively too early.

The U.S. Nationwide Institutes of Well being and the American Academy of Pediatrics each suggest infants sleep on their backs in a naked crib on a flat—not inclined—floor with out pillows, toys, smooth objects or free bedding.

These suggestions are supposed to assist cut back the danger of Sudden Surprising Toddler Demise (SUID), a class that features Sudden Toddler Demise Syndrome (SIDS).

Well being care suppliers ought to discourage the usage of toddler head-shaping pillows and educate their sufferers in regards to the dangers, the FDA added.

Toddler head-shaping pillows are sometimes small, with an indent or gap within the heart designed to cradle the again of an toddler’s head whereas the toddler lays face up.

Some would not have the indent and are rectangular-shaped.

The FDA has cleared caps, helmets or head bands to enhance head symmetry or form in infants and toddlers from 3 months to 18 months of age.

Some units are additionally supposed for infants from 3 to 18 months of age whose head form has been surgically corrected, however who nonetheless have a moderate-to-severe flat head, the FDA mentioned.

The company mentioned it has communicated its considerations about promotional supplies to corporations that make these pillows and can proceed to watch claims for these merchandise.

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