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


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From FDA https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628900.htm

“Date Issued

December 20, 2018

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.

...

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.

...

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.”

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Is it just me that's doing an eye roll? I mean, I get it. Yeah, it could be dangerous. Yes, one toddler died because parents left it on and put the child in a crib & that is a tragedy.

But surely the real dangers are cars, guns, parents. 450 kids under 5 are murdered by their parents every year. Should  there be a gov't report saying "we have received a  report of the danger of parents..."  I mean the risks of so many other things are so much greater. Are the priorities in the right place?  

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Seriously.

Every teething bracelet/necklace I have seen come with a paper that says not to leave them on during naps/bedtime and the beads are individually knotted so that the choking hazard is minimal.

When my youngest was a baby, there were EIGHT recalls of infant pain relievers.  We couldn't get anything for teething.  Thanks, but I'll stick to something that wasn't going to poison my kid and is perfectly safe when used correctly. 

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Just now, Seasider too said:

Eye rolling because some things are just common sense, y’know?

But this is a good opportunity for me to ask about the whole amber bead necklaces on babies phenomena. That’s something that came after mine were way past the teething stage. What’s that all about? 

The amber releases a natural pain reliever that is absorbed through the skin.

I thought it was total bunk until I took my kid's necklace one day and wrapped it around my wrist.  Within 2 days the constant back pain I had had from my epidural was gone.  He slowly got crankier until I gave it back.  I don't believe it works for everyone, but it was a last ditch effort for us and it did work beautifully.  I nearly had a nervous breakdown from his crying until we got him one to wear.

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I'm gonna go with woo on the amber, before looking it up

If it releases a pain reliever, why not just apply the pain reliever every now and then and skip the necklace part, thus avoiding any chance of strangulation, etc.?  I mean, we don't wear ibuprofen necklaces.

 

Okay, looked it up, it's woo

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1 hour ago, HomeAgain said:

Every teething bracelet/necklace I have seen come with a paper that says not to leave them on during naps/bedtime and the beads are individually knotted so that the choking hazard is minimal.
 

Not arguing about effectiveness, I haven't used them so I have no idea. But the people I know whose babies/toddlers wear these tell me that they wear them 24/7 and never take them off. Ever.

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1 hour ago, gardenmom5 said:

I've actually been surprised they had these things on the market because the choking hazard has long been known about.  and I was having babies in the 80's.

Many of the products mentioned in the FDA warning are now used by a lot of older kids - like preschool and elementary age and even older - who are sensory seeking. So in that sense, they absolutely should still be on the market.

But those are typically marketed slightly differently. I wonder if the increased availability of those products are actually the issue here.

I can't imagine giving a baby a necklace like that. If you want them to be able to get it when they drop it (as they inevitably will) then making them on those tiny clips like pacifiers are would seem to make way more sense.

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13 minutes ago, Momto5inIN said:

But the people I know whose babies/toddlers wear these tell me that they wear them 24/7 and never take them off. Ever.

 

Below quoted instructions is scary from a safety standpoint because the caregiver might forget to remove the necklace.

 

“How Does a Baltic Wonder Necklace Help With Sleep?

While your baby can’t sleep with the necklace on (for safety reasons), Baltic Wonder amber teething necklaces are a great remedy for an overtired teether who can’t seem to settle down. If your baby tends to fall asleep in the car, slip on the necklace before you head out for a little pre-nap trip. The amber will start to work its magic, and after you’ve returned home with a slumbering little one you can slip the necklace off. If your baby is a fan of falling asleep on top of you, it’s even easier—just let him or her wear the necklace until they calm and drift off, and then make sure you remove the necklace before you put your baby in their bed.” https://www.slumber-baby.com/help-teething-baby-sleep-using-baltic-amber/

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Who would have thought that it might be a bad idea to put a necklace made of choking hazards on an infant. 🙄

Fyi, the temperature at which baltic amber turns into succinic acid is 187 degrees Celsius. So unless your baby is LITERALLY ON FIRE, it's a combination of woo and the placebo effect.

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59 minutes ago, Farrar said:

Many of the products mentioned in the FDA warning are now used by a lot of older kids - like preschool and elementary age and even older - who are sensory seeking. So in that sense, they absolutely should still be on the market.

But those are typically marketed slightly differently. I wonder if the increased availability of those products are actually the issue here.

I can't imagine giving a baby a necklace like that. If you want them to be able to get it when they drop it (as they inevitably will) then making them on those tiny clips like pacifiers are would seem to make way more sense.

new grandma here - they're marketing these for babies.  not preschoolers, or even toddlers, but babies.

and I agree -  - just make it like a pacifier clip.

and I'm familiar with the chewies for school age sensory seekers.

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So this is anecdotal, but I've used those amber teething necklaces with 4 kids so far.  I could never tell that they did anything for pain, but they definitely did something for one of my babies.  I thought he was done teething for a while and took his necklace off (yes I'm one of those people who left them on all the time).  He started drooling like crazy.  After a couple of days of this I put the necklace back on, and within an hour he'd stopped drooling.  Took it off again, and he started drooling a ton. This happened a couple different times, so it seems to me the necklace was doing something, whatever that something might be.

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14 hours ago, Farrar said:

Many of the products mentioned in the FDA warning are now used by a lot of older kids - like preschool and elementary age and even older - who are sensory seeking. So in that sense, they absolutely should still be on the market.

But those are typically marketed slightly differently. I wonder if the increased availability of those products are actually the issue here.

I can't imagine giving a baby a necklace like that. If you want them to be able to get it when they drop it (as they inevitably will) then making them on those tiny clips like pacifiers are would seem to make way more sense.

We just bought dd, who has anxiety, a chewelry necklace.  She really likes it, it's too big to be a chocking hazard (it's shaped like a donut) and the string has a safety clasp that will pull open with any kind of pull.  But, it is a long string so I've told her she's not to wear it to sleep.

It would never occur to me to allow a baby to wear something around their neck to bed.  But, I'm also pretty paranoid even with my older kids.

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fwiw, I think circumcision should be illegal

but the idea I get about the teething necklaces is that there is no actual benefit, aside from the placebo - there's absolutely no evidence at all for any actual effect.  circumcision does reduce UTI rates, I think (although I admit I haven't done the research myself), so there is a documented benefit.

 

Now for me, I don't care that it reduces UTI rates, I still think it's barbaric and cruel and insane.

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13 hours ago, hornblower said:

huh. I'm Polish, a country obsessed with amber - necklaces, bracelets, figurines, decorations, you name it, I have it - and I've never heard of amber for health or cranky babies

Same here. 

 

14 hours ago, Mergath said:

Who would have thought that it might be a bad idea to put a necklace made of choking hazards on an infant. 🙄

Fyi, the temperature at which baltic amber turns into succinic acid is 187 degrees Celsius. So unless your baby is LITERALLY ON FIRE, it's a combination of woo and the placebo effect.

LOL 

Now for all the over-regulations :

I do not like nanny state policies.  My husband keeps watching Science Channel, usually to my great annoyance (not because I hate science but because of the presentations and "ancient alien scientist says" type garbage.  Anyway, one of the overhyped shows-- so many channels have gotten into "Everyone dies" type stuff - which skew true dangers to some odd random happenings- was blaring something about nuclear power plants, etc in the list of dangers.  And that made me immediately think of that we need Potassium Iodide pills each because we do live close to nuclear plants and the last person travels to areas near nuke plants and I remembered seeing cheap packets on Amazon.  So I called my pharmacy and asked if they stocked it and would I need a script.  No, they do not stock it and yes, I need a script.  Went on Amazon and ordered them and getting them from Florida. Oh and btw, my doctor would have written it, etc but this is last minute stocking stuffer. Same thing with my nebulizer-  I wanted an international travel kind that no one had locally.  I had prescriptions but they couldn't get one for me in time for my trip.   Ordered one online at a med supply service and in that state, they didn't even need a prescription.    Also, I never bought flame resistant pajamas for anyone- and yes, I know cotton goes on fire quickly especially flannel kinds-- but much better than melting on your body and you can't get off the super hot melted goo.

And then there are all the people calling for more-   some drug addicts figured out that if you take super amounts of one of the anti-diarrhea you can get high, so some mom of a drug addict wanted to make it prescription only. 

I am becoming super libertarian on all these things.  Take responsibility for yourself and your family.

 

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8 hours ago, moonflower said:

fwiw, I think circumcision should be illegal

but the idea I get about the teething necklaces is that there is no actual benefit, aside from the placebo - there's absolutely no evidence at all for any actual effect.  circumcision does reduce UTI rates, I think (although I admit I haven't done the research myself), so there is a documented benefit.

 

Now for me, I don't care that it reduces UTI rates, I still think it's barbaric and cruel and insane.

Antibiotics will cure a UTI without the risks that circumcision carries. (And UTIs in boys are relatively uncommon anyway, so the benefit of circumcision is actually pretty minimal)

I have found that using my motherly instinct and common sense to be far more effective than listening to what the government has to say about what's best for babies. Like I said, I have never used amber teething necklaces but a lot of people I know swear that they work. I'd rather a mom try that then give her baby regular doses of tylenol or other pain relievers.

 

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