Previously issued MedWatch Safety Alert email contained information from the 2010 MedWatch Safety Alert on Infant Sleep Positioners. Most current MedWatch Safety Alert:
Infant Sleep Positioners: FDA Warning - Risk of Suffocation
AUDIENCE: Consumer, Pediatrics
ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.
Each year, about 4,000 infants die unexpectedly during sleep time from accidental suffocation, SIDS, or unknown causes, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The federal government has received reports about babies who have died from suffocation associated with their sleep positioners. In most of these cases, the babies suffocated after rolling from their sides to their stomachs.
In addition to reports about deaths, the federal government also has received reports about babies who were placed on their backs or sides in positioners—but were later found in other, dangerous positions within or next to these products.
To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.
BACKGROUND: The two most common types of sleep positioners feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head. The positioners are intended to keep a baby in a specific position while sleeping and are intended for infants under 6 months old.
RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.
- NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
- NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
- ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
- ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the Consumer Update, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm578531.htm
