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FDA Emphasizes Danger of Sleep Positioners

A recent U.S. Food and Drug Administration (FDA) news release emphasizes that infants should only be put to sleep on their backs on a cleared, firm surface with no use of sleep positioners.

Sleep positioners, also referred to as anti-roll supports or nests, can be dangerous. These products are most commonly formed by two raised pillows attached to a mat designed to hold babies six months old or younger. These products claim that by placing the baby to sleep on the mat, the positioner will keep the baby in a specific position throughout sleep.

However, the American Academy of Pediatrics states that sleeping near soft objects like pillows, toys, and positioners increases the risk of suffocation and Sudden Infant Death Syndrome (SIDS). Each year, about 4,000 infants die unexpectedly while sleeping.

The FDA explained that some infants have been found in dangerous positions next to a positioner, and others have died after being put to sleep with these products (usually due to suffocation). The FDA regulates products that claim to treat, cure, or prevent a condition or disease. Some positioner companies claim that the products help to prevent SIDS, but the FDA indicates that it has never cleared a sleep positioner that makes these claims.

Companies making positioners that were previously approved after claiming to reduce flat head syndrome and gastroesophageal reflux disease have been asked to stop marketing these items because the risks outweigh any potential benefits.

Parents are encouraged to talk to their baby’s doctor about safe sleep approaches.

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