Parents Should Not Have Their Infants Sleep On Head-Shaping Pillows, FDA Warns

The US FDA says the safety and efficacy of pillows to correct the shape of an infant’s head have not been demonstrated. The devices could pose a risk of serious harm to the infant, including death.

The US Food and Drug Administration is advising parents and caregivers not to use pillows designed to change the shape and symmetry of an infant’s head. Using these devices can create an unsafe sleeping environment for infants and may contribute to the risk of suffocation and death, the FDA warns in a safety communication issued on 3 November.

The pillows claim to treat flat-head syndrome, or plagiocephaly, a condition that can develop if a newborn sleeps on the...

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