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New FDA warning advises parents against using head pillows for babies

By Cradlewise Staff

A recent advisory issued by the U.S. Food and Drug Administration (FDA) on November 3, 2022, recommends that “parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition.” 

If you are a parent, this might come as a surprise, considering that these cute little infant head-shaping pillows are widely marketed as a solution to prevent (and sometimes treat) plagiocephaly, also known as flat head syndrome.

However, the FDA states that there is no demonstrated benefit of using such pillows for medical purposes. In fact, head-shaping pillows can be dangerous for babies, as they have the potential to create unsafe sleep environments and may even lead to suffocation and death.  

What are head-shaping pillows?

The FDA recognizes head-shaping pillows as “typically small pillows, with an indent or hole in the center designed to cradle the back of an infant’s head while the infant lays face up, flat on its back.”

However, sometimes these pillows are rectangular and don’t have a hole or indent in the center. Besides being called head-shaping pillows, some of these pillows will also be labeled and sold under names like baby head support pillows, head cushions, flat head pillows, or anti-flat head pillows. They often claim to help plagiocephaly because they support the baby’s head and neck. 

Plagiocephaly refers to an easily treatable disorder that occurs when a baby’s head is flat in either the back or on one side of the head. It can develop when a baby spends too much time lying on their back or when they sleep with their head on the same side during the first few months after birth. Plagiocephaly doesn’t interfere with a baby’s development.

It’s important for parents to note that infant head-shaping pillows are not FDA-approved. And, as the Administration warns, “The safety and effectiveness of using these medical devices have not been demonstrated.”

Why did the FDA issue this warning?

Recently, various companies that have been marketing baby head-shaping pillows for the prevention and treatment of plagiocephaly came to the FDA’s attention because they were being marketed without FDA clearance or approval. 

The FDA has communicated its concerns about such promotional materials to these companies and, as they said in their statement, “will continue to monitor promotional materials and claims for these medical devices.”

Although head-shaping pillows are a big no-no, the FDA has cleared caps, helmets, or headbands for infants and toddlers (3 months to 18 months) to improve head symmetry or shape.

What to do if you’re worried about your baby’s head shape

  • Talk to your doctor. If the shape of your baby’s skull is flat and you’re worried about it, it’s best to first talk to your pediatrician about your concerns, rather than start any type of home treatment on your own.

    Although it’s likely not a cause for concern, your doctor will want to rule out more serious conditions associated with abnormal head shape, such as craniosynostosis, which is a birth defect that occurs when the bones in the skull join too early. They might also recommend a treatment plan that includes lifestyle changes (like maximizing tummy time or wearing a helmet) or maybe even physical therapy.

    As the FDA states, “Know that the use of infant head-shaping pillows may delay the necessary evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis.” 

    It’s also important to note that it’s common for babies to have a flat head, and you might not need any treatment at all, other than a little patience and time. As the FDA says, “Be aware that, in most cases, the flat head syndrome will go away on its own as an infant grows, it is not painful, and it does not cause any developmental concerns.”
  • Don’t donate your baby’s pillow. If your little one uses a head-shaping pillow, the FDA advises you to throw it away immediately, rather than giving it away or donating it, since it might pose a risk to another baby’s life. Remember that head-shaping pillows pose a health risk of sudden unexpected infant death (SUID) and sudden infant death syndrome (SIDS) for children.
  • Keep the sleep surface and area safe. Always ensure that your baby is sleeping on their back, on a firm and flat surface, with no toys, pillows, blankets, or loose clothing in their sleeping area. Follow the American Academy of Pediatrics’ safe sleep guidelines to ensure your little one’s safety.

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