Associated Press
Those soft fabric sleep positioners that parents put in the crib to keep babies safely sleeping on their backs could be dangerous, even deadly, for little ones, the government warned Wednesday.
Citing 12 deaths, the Food and Drug Administration and the Consumer Product Safety Commission said the positioners are not safe and that parents, caregivers and others should not use them at all because of a suffocation risk.
The babies, ranging in age from 1 to 4 months, died when they suffocated in the positioner or became trapped between the positioner and the side of a crib and then suffocated. The deaths spanned the last 13 years.
Most of the babies suffocated after rolling from a side to stomach position, the agencies said in their joint announcement.
"In most instances, these products provide no real benefit and the risk of harm when they are used is significantly greater," cautioned FDA deputy commissioner Joshua Sharfstein, during a teleconference with reporters.
CPSC Chairman Inez Tenenbaum said her agency has received dozens of reports of babies who were placed on their backs or sides in the positioners and were later found in a potentially dangerous position inside the positioner or next to it.
The positioners are usually made of a soft cloth mat with a cushion on each side to hug or cradle the baby on her back. Marketed for babies ages 6 months and younger, positioners are promoted as a way to keep a young infant from rolling onto his tummy during sleep, or as a way to prevent sudden infant death syndrome, or SIDS, or to ease acid reflux.
Judy Sage lost one of her twin sons in 2002 when 8-week-old Andy suffocated in a positioner. Following Wednesday's warning she said: "Andy's smiling down on us for sure."
Sage said it was heartbreaking that it took multiple deaths to bring change, but she added that she hoped the government warning would "keep another family from the grief our family has suffered."
The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. He said FDA has approved 18 sleep positioner products over the years, mostly for reflux or flat head syndrome.
FDA has reached out to all of the 18 manufacturers and asked them to stop selling their products and provide the agency with any information they might have that the benefits of the positioners outweigh the risks, Sharfstein said.
Neither CPSC or FDA has had any recalls of sleep positioners, but Sharfstein said to expect recalls in the future.
Nancy Cowles, executive director of Kids In Danger, said the warning to consumers was a good first step. "We look to the leadership of retailers to stop selling what has now been declared an unsafe and unnecessary product," said Cowles.
The American Academy of Pediatrics has long urged parents not to use positioners.
Dr. Rachel Moon, chair of the SIDS task force at the academy, said there is no evidence to support claims that positioners reduce the risk of SIDS.
For parents concerned about reflux, Moon said they don't need to do anything special for their babies other than burping them after feedings and placing them on their backs for sleep.
Citing 12 deaths, the Food and Drug Administration and the Consumer Product Safety Commission said the positioners are not safe and that parents, caregivers and others should not use them at all because of a suffocation risk.
The babies, ranging in age from 1 to 4 months, died when they suffocated in the positioner or became trapped between the positioner and the side of a crib and then suffocated. The deaths spanned the last 13 years.
Most of the babies suffocated after rolling from a side to stomach position, the agencies said in their joint announcement.
"In most instances, these products provide no real benefit and the risk of harm when they are used is significantly greater," cautioned FDA deputy commissioner Joshua Sharfstein, during a teleconference with reporters.
CPSC Chairman Inez Tenenbaum said her agency has received dozens of reports of babies who were placed on their backs or sides in the positioners and were later found in a potentially dangerous position inside the positioner or next to it.
The positioners are usually made of a soft cloth mat with a cushion on each side to hug or cradle the baby on her back. Marketed for babies ages 6 months and younger, positioners are promoted as a way to keep a young infant from rolling onto his tummy during sleep, or as a way to prevent sudden infant death syndrome, or SIDS, or to ease acid reflux.
Judy Sage lost one of her twin sons in 2002 when 8-week-old Andy suffocated in a positioner. Following Wednesday's warning she said: "Andy's smiling down on us for sure."
Sage said it was heartbreaking that it took multiple deaths to bring change, but she added that she hoped the government warning would "keep another family from the grief our family has suffered."
The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. He said FDA has approved 18 sleep positioner products over the years, mostly for reflux or flat head syndrome.
FDA has reached out to all of the 18 manufacturers and asked them to stop selling their products and provide the agency with any information they might have that the benefits of the positioners outweigh the risks, Sharfstein said.
Neither CPSC or FDA has had any recalls of sleep positioners, but Sharfstein said to expect recalls in the future.
Nancy Cowles, executive director of Kids In Danger, said the warning to consumers was a good first step. "We look to the leadership of retailers to stop selling what has now been declared an unsafe and unnecessary product," said Cowles.
The American Academy of Pediatrics has long urged parents not to use positioners.
Dr. Rachel Moon, chair of the SIDS task force at the academy, said there is no evidence to support claims that positioners reduce the risk of SIDS.
For parents concerned about reflux, Moon said they don't need to do anything special for their babies other than burping them after feedings and placing them on their backs for sleep.
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