September 29, 2010
Two government agencies and the American Academy of Pediatrics are warning parents and other caregivers not to put babies in sleep positioning products as two recent deaths underscore concerns about suffocation.
The Food and Drug Administration (FDA) and the Consumer Product Safety Commission issued the warning after reviewing reports of 12 known infant deaths associated with the products.
Sleep positioners have been on the market for more than 20 years, especially for acid reflux or “flat head syndrome.” The FDA cleared 18 positioning devices for sale at that time, but the FDA now believes that the modest potential benefit does not outweigh the risks.
According to the FDA, “The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.
Some of these products claim that they reduce the risk of Sudden Infant Death Syndrome (SIDS), but there is no evidence that they are effective. To reduce the risk of SIDS, the American Academy of Pediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding.
Dr. Diana Zuckerman, president of the National Research Center for Women & Families, points out that parents should be careful what they put in places where babies sleep. “For many years, companies have sold products that they claim reduce SIDS, that they claim help babies sleep, or that are supposed to comfort babies, but many of these products have been found to increase the risk of suffocation. In addition to infant sleep positioners, we are concerned about pillows, soft, fluffy and shaggy blankets, comforters, and mattress covers, and other products that can cover a child’s nostrils or interfere with an infant’s breathing. Parents should keep cribs and basinets free of products or materials like that, using a regular fitted sheet or simple baby blanket. And babies should sleep on their back (remember – infants should go back to sleep.”
STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.
NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.
ALWAYS place a baby on his or her back at night and during nap time.
REPORT an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission by visiting www.cpsc.gov/cgibin/incident.aspx5 or calling 800-638-2772, or to FDA’s MedWatch program6.
Suffocation and Other Dangers
In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.
In addition to the deaths, the 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.
“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,” says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.
FDA pediatric expert Susan Cummins, M.D., M.P.H, says 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 says. “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.”
Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD)-in which stomach acids back up into the esophagus-or flat head syndrome, a deformation caused by pressure on one part of the skull.
Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new information suggests the positioners pose a risk of suffocation.
As a result, FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products’ benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data.
Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately, agency experts say, adding there’s no evidence the devices have benefits that outweigh the risk of suffocation.
“At this time, there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners,” says Cummins.
This article appears on FDA’s Consumer Updates page7, which features the latest on all FDA-regulated products.
Posted: September 29, 2010