WASHINGTON -  The U.S. Food and Drug Administration has issued a warning to parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, saying it can lead to death or serious injury.

The warning is meant especially for babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy type 1, Down syndrome, or cerebral palsy.

Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in the water.

The FDA says it has not evaluated the neck floats and is not aware of any demonstrated benefit with their use for water therapy interventions.

The risks of using baby neck floats include death due to drowning and suffocation, strain, and injury to a baby’s neck. Babies with special needs such as spina bifida or SMA Type 1 may be at an increased risk for serious injury.

The FDA says it is aware of one baby who died and one baby who was hospitalized related to the use of baby neck floats. In both cases, the babies were injured when their caregivers were not directly monitoring them.

Some neck floats are marketed for babies as young as two weeks old or premature babies and are designed to cradle a baby's head while their body moves freely in the water.

Parents and caregivers have used these products during a baby’s bath, while their baby is swimming, and as a physical therapy tool for babies with developmental delays or disabilities.

The FDA says that some manufacturers are claiming these products support water therapy interventions in babies with developmental delays or special needs and that the benefits of these products include increased muscle tone, greater flexibility, and range of motion, increased lung capacity, better sleep quality, and increased brain and nervous system stimulation.

However, according to the FDA, the safety and effectiveness of neck floats to build strength, promote motor development, or as a physical therapy tool, have not been established.

While the FDA believes that death or serious injury from neck floats is rare, health care providers, parents, and caregivers should be aware that these events can and do occur. It is also possible that some cases have not been reported to the FDA.

Anyone experiencing adverse events associated with using neck floats may file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.