Infant sleep positioners, which manufacturers claim can help prevent sudden infant death, are themselves deadly, according to a harsh warning released Wednesday by federal regulators.
Over the past 13 years, 12 infants have died after suffocating in sleep positioners, according to the Consumer Product Safety Commission and the FDA, two federal agencies overseeing the safety of in-home products.
Most of the infants suffocated after rolling from a side to stomach position.
Sleep positioners often make wide-ranging safety claims, including that they reduce the risk of SIDS by helping to keep infants on their backs; aid in food digestion; ease colic; and prevent flat head syndrome. But the FDA has never validated any of these claims, and Dr. Joshua Sharfstein, the agency's principal deputy commissioner and a pediatrician, says parents shouldn't take them at face value.
"To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS," Sharfstein says. "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners."
American Academy of Pediatrics tips for healthy sleep:
For more information, or to report a problem with an infant sleep positioner, visit the FDA's safety website.
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