Baby sleep positioners -- mats with barriers to prevent a baby from rolling over -- carry a risk of suffocation and death, and should not be used under any circumstances, the FDA and Consumer Product Safety Commission (CPSC) warned.
The advisory was prompted by reports of 12 deaths among infants from 1 to 4 months of age received by the CPSC over the past 13 years, in addition to dozens of additional nonfatal cases in which babies awoke in unsafe positions after being placed in a sleep positioner.
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The FDA has approved 18 infant sleep positioners since the early 1980s because of some evidence that the devices ease the symptoms of gastroesophageal reflux disease (GERD) and prevent flattening of one side of the skull, but many more than 18 such products are available on the market, according to Dr. Joshua Sharfstein, principal deputy commissioner of the FDA.
Many manufacturers claim that their products can also reduce the risk of sudden infant death syndrome (SIDS), although the FDA has not approved any devices for this indication. Sharfstein said on a conference call with reporters that he is not aware of any studies supporting that claim.
He said that none of the devices should be used and that "the modest evidence of benefit does not outweigh the risk."
The FDA recently contacted the manufacturers of the agency-approved devices asking them to stop marketing their products unless they can submit data showing that the benefits outweigh the suffocation risks.
Sharfstein said the agency has not heard back from all of the device makers, but expects all of them to comply with the demands.
CPSC chairman Inez Tenenbaum said the warning against infant sleep positioners is one component of the agency's Safe Sleep Initiative. Others include new standards for cribs and bassinets that are under development and efforts to educate parents about keeping soft bedding out of the infant sleep environment and placing babies on their back to sleep at night and during nap time.
Dr. Rachel Moon, a pediatrician at Children's National Medical Center in Washington and chair of the SIDS task force for the American Academy of Pediatrics, said the AAP supports the warning about the sleep positioners.
"Because there's no scientific evidence that sleep positioners protect against SIDS and suffocation, they make gastroesophageal reflux better, or they prevent flat head, and given that there is at least a risk of injury or even death when infants are placed in these devices," she said, "to me, they do not pass the test of 'First, do no harm.'"
The FDA may follow up with enforcement actions or recall specific products in the future, Sharfstein said, adding that a warning was considered the fastest way to convey the message about the dangers of infant sleep positioners to the public.