Wednesday, January 2, 2019

FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed for Relieving Teething Pain or Providing Sensory Stimulation: FDA Safety Communication

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Here is a recent alert for parents of infants that are teething.  This is important info and should be read by all new and recent parents.
 

Audience
Parents or caregivers of infants with teething pain.
Parents or caregivers of individuals with special needs, such as autism or attention-deficit/hyperactivity disorder (ADHD), who use necklaces and bracelets to provide sensory stimulation or redirect chewing.
Health care providers who interact with these caregivers who use or may consider using necklaces and bracelets marketed for relieving teething pain or providing sensory stimulation.

Medical Specialties
All primary care specialties including general pediatrics, pediatric dentistry, family medicine, general internal medicine, family and pediatric nurse practitioners.
Psychologists, psychiatrists, developmental and behavioral specialists, occupational therapists, physical therapists, general nursing and certified nursing assistants.

Product
Teething jewelry includes necklaces, bracelets, and other jewelry that can be worn by either an adult or child, and is often marketed to relieve an infant’s teething pain. The beads of the jewelry may be made with various materials such as amber, wood, marble, or silicone. Jewelry marketed for teething pain is not the same as teething rings or teethers, which are made of hard plastic or rubber, and are not worn by an adult or child.

Teething jewelry may also be used by people with special needs, such as autism or attention-deficit/hyperactivity disorder (ADHD), to provide sensory stimulation or redirect chewing on clothes or body parts.

Purpose
The FDA is alerting parents, caregivers, and health care providers that necklaces, bracelets, and other jewelry marketed for relieving teething pain should not be used with infants or to provide sensory stimulation to persons with special needs, such as autism or attention-deficit/hyperactivity disorder. Such use could lead to strangulation, choking, serious injuries, or death. The safety and effectiveness of teething jewelry to treat teething pain and/or provide sensory stimulation have not been established.

Summary of Problem and Scope
The FDA has received reports of death and serious injuries to infants and children, including strangulation and choking, caused by necklaces and bracelets often marketed for relieving teething pain. Parents and other caregivers may use these products to help relieve teething pain or to provide sensory stimulation in people with special needs. The risks of using teething jewelry include choking, strangulation, injury to the mouth, and infection. Choking may occur if the jewelry breaks and small beads or the whole piece of jewelry enter the child’s throat or airway.

The FDA received a report of a 7-month old child who choked on the beads of a wooden teething bracelet while under parental supervision and was taken to the hospital as a precaution. Strangulation can happen if a necklace is wrapped too tightly around the child’s neck or if the necklace catches on an object such as a crib. The FDA received a report of an 18-month old child who was strangled to death by his amber teething necklace during a nap. Other concerns include potential injury to the mouth or infection if a piece of the jewelry irritates or pierces the child’s gums.

Recommendations for Parents and Caregivers

  • Do not use necklaces, bracelets, or any other jewelry marketed for relieving teething pain. The use of these products can lead to serious injuries including strangulation or choking.
  • Be aware that the use of jewelry marketed for relieving teething pain or provide sensory stimulation to people with special needs can lead to serious injuries including strangulation or choking.
  • Review the American Academy of Pediatrics’ recommendations for treating teething pain .
  • Talk to your doctor about alternative ways you can reduce teething pain such as:gently rubbing or massaging the gums with a clean finger
  • giving the teething child a teething ring made of firm rubberMake sure the teething ring is not frozen. If the object is too hard, it can hurt the child’s gums. Parents and caregivers should supervise the child during use.
  • Avoid teething creams and benzocaine gels, sprays, ointments, solutions, and lozenges for mouth and gum pain in infants and children younger than 2 years. Benzocaine and other local anesthetics can cause methemoglobinemia, a serious condition in which the amount of oxygen carried through the blood is reduced. This condition is life-threatening and can result in death.

Recommendations for Health Care Providers

  • Talk to parents or caregivers about safe ways to reduce teething pain , including the benefits and risks of available treatment options.
  • Discourage use of necklaces, bracelets, and other jewelry marketed for relieving teething pain. 
  • Discourage use of necklaces, bracelets, and other jewelry for providing sensory stimulation to people with special needs

FDA Actions
The FDA is closely monitoring adverse event reports associated with teething jewelry and is committed to protecting public health and assuring the safety of children and others. The FDA will update this communication if significant new information becomes available.

Reporting Problems to the FDA
If you experience an injury or adverse event when using teething jewelry, the FDA encourages you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program. Please include the following information in your reports:

  • Device Name (Brand Name)
  • Manufacturer’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices.

Additional Resources
American Dental Association- Teething Recommendations
FDA Safety Communication- Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
American Academy of Pediatrics Alert- Amber Teething Necklaces: A Caution for Parents
American Academy of Pediatrics- Sensory Integration Therapy
Consumer Update: Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children

Contact Information
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

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