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FDA: Sleep positioning devices dangerous for babies

The federal government is warning parents against using devices designed to keep their babies sleeping on their backs, saying they can actually increase the risk of infant deaths instead of preventing them.

The Food and Drug Administration, Consumer Product Safety Commission and the American Academy of Pediatrics issued the joint warning Wednesday advising against the use of such products.

Sudden infant death syndrome, more commonly known as SIDS, is a condition in which an infant dies suddenly for unexplained reasons in their sleep. More than 4,500 infants die suddenly for no obvious reason each year in the United States, and about half of those are due to SIDS, according to the federal Centers for Disease Control and Prevention. It is the leading cause of death of infants in their first year of life.

But there are a number of things parents can do to reduce the risk for SIDS. Most notably, studies have shown that putting babies to sleep on their backs can significantly reduce the risk. The number of SIDS deaths fell by half since public health officials began a campaign to get more parents to make sure their babies sleep on their backs. Making sure babies are sleeping on firm surfaces without any soft objects such as stuffed animals and loose bedding also prevents SIDS.

Two government agencies are warning parents and other caregivers not to put babies in sleep positioning products as two recent deaths underscore concerns about suffocation. (FDA)

Sleep positioning devices are often used on infants younger than six months and are supposed to hold infants in one spot, supposedly preventing the baby from rolling over on his or her stomach or wiggling too close to the edge of the crib where he or she could become trapped. The most common types of sleep positioners have bolsters attached to each side of a thin mat and wedges to elevate the baby's head.

Some companies advertise the products also can prevent gastroesophageal reflux disease (GERD)--in which stomach acids back up into the esophagus--and "flat head syndrome," which is a deformation caused by pressure on one part of the skull.

But officials say they issued the warning after reviewing reports of 12 known infant deaths associated with the products over the past 13 years, including two recent deaths.

"Most of the babies suffocated after rolling from the side to the stomach." according to a posting on the FDA Web site.

In addition to the deaths, the Consumer Product Safety Commission has received "dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product," the statement said.

"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep," said Inez Tenenbaum, chairman of the Consumer Product Safety Commission.

Susan Cummins, a pediatric safety expert at the FDA, said parents and caregivers can create a safe sleep environment for babies if they leave the crib free of pillows, comforters, quilts, toys and other items.

"The safest crib is a bare crib," she said. "Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC's of safe sleep--Alone on the Back in a bare Crib."

The warning was welcomed by consumer advocates.

"We strongly urge parents to ignore the hard sell for many of these infant products, and we beseech companies to be more careful before they sell products that could potentially kill our babies," said Diana Zuckerman of the National Research Center for Women & Families in Washington. "It is unfortunate that we live in a society where so many parents think they need to buy fancy products to help their infants sleep. There are many safe and effective and free strategies that parents can use to help babies sleep, such as burping them after they eat and putting them to sleep on their backs."

By Rob Stein  | September 29, 2010; 12:30 PM ET
Categories:  FDA, Infant health, Injury prevention, Kids' health, Motherhood, Parenting, Sleep  
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If they know the child suffocated, how could it be SIDS, which indicates that the cause is unknown?

Posted by: CalBears1 | September 29, 2010 3:28 PM | Report abuse

Seems like bologna to me. 12 babies in 13 year’s time seems like an extremely low number to me. Not to forsake their deaths but I think the positioners were not used right or something else about each situation isn't 100%. If you use the right positioner properly the baby should never be at risk to fall onto their face. If they do, you as the parent shouldn't be far behind to correct it. Don't you have to feed them every 3 hours? Also, if you have a positioner, didn't you also invest in a baby monitor (with video)? My two sons used positioners and they were fine. In fact, I would believe more than fine because when they spit up, it was able to drain to the side and into the absorber on the positioner, not back into their throat. I don't know about you but no matter how much I burp my son before putting him down he always manages to regurgitate something from what he ate. Good luck.

Posted by: bossee | September 29, 2010 4:30 PM | Report abuse

This is beyond ridiculous. Specially coming from the FDA that's always asking for rigurous studies to be able to claim anything. Anecdotal evidence from 12 cases where positioning devices were used doesn't mean anything without comparable information about cases where they were not used. Where is the double-blinded study? Also, the CPSC received "dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product", again how often are babies not using the devices found in "hazardous positions"???

Posted by: ogs123 | September 29, 2010 4:41 PM | Report abuse

I guess we'll never know how many deaths infant positioners prevented in those 13 years.

Posted by: nlynnc | September 30, 2010 11:17 AM | Report abuse

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