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FDA warns about benzocaine in baby pain gels
June 1st, 2012
12:15 PM ET

FDA warns about benzocaine in baby pain gels

When your baby begins to teethe and the pain is too much for you both to bear, your inclination is to reach for something to soothe those sore gums. But a new consumer update released by the Food and Drug Administration says babies and benzocaine–an ingredient found in many over the counter pain gels and liquids–don't mix.

Benzocaine is a local anesthetic that's in products like Anbesol, Orajel & Baby Orajel, Orabase and Hurricaine. The FDA says using benzocaine products to stop mouth and gum pain can cause a rare and sometimes fatal condition called methemoglobinemia. Methemoglobinemia is a blood disorder where the oxygen that's carried through the blood to the tissue drops to dangerously low levels. In severe cases it can cause death.

The FDA first sounded the alarm on these products in 2006. Since then there have been 29 reports of benzocaine gel-related cases of methemoglobinemia. FDA pharmacist Kellie Taylor says 19 of those cases were in children, 15 of those 19 were children under the age of 2.

The agency issued another warning in 2011. Some of the symptoms to look for include pale, gray, or blue-colored skin, lips and fingernail beds, shortness of breath, headache, light-headedness and rapid heart rate.

"Symptoms can occur within minutes to hours after benozcaine use," says FDA Pharmacist Mary Ghods said. "They can occur after using the drug for the first time, as well as after several uses."

If your child experiences any of these symptoms after using these products Ghods recommends seeking medical help immediately.

According to the American Academy of Pediatrics giving your child a chilled teething ring or gently massaging their gums with your finger are alternative ways to treat teething discomfort.

But it's not just children that are affected. Adults who smoke, those with heart disease or respiratory problems like asthma, bronchitis or emphysema are at increased risk of complications of methemoglobinemia.

The FDA advises that consumers who have these products store them out of their child's reach and use products with benzocaine only when necessary - and then no more than four times a day.


soundoff (77 Responses)
  1. BRUCE

    WHAT DID JUSTIN BIEBER SAY ABOUT THIS GEL?

    June 1, 2012 at 13:05 | Report abuse | Reply
    • Kissfan07

      It's all good.

      June 1, 2012 at 13:10 | Report abuse |
    • jason83

      who the hell is justin bieber? oh wait,,it's that stupid kid who keeps walking into glass everytime he says his own reflection in glass. Too bad he can't shatter instead of the glass!

      June 4, 2012 at 13:38 | Report abuse |
  2. Anna

    which is why putting a little whiskey on your finger and rubbing it on your baby's gums is the best option – all natural

    June 1, 2012 at 13:13 | Report abuse | Reply
    • weezer

      My mom did this - and also would give us whiskey and honey for a cough...would even leave the mixture by our beds if we needed it during the night. Both my sister and I have loved whiskey our entire lives - now i drink single malts. Thanks Mom!

      June 1, 2012 at 14:00 | Report abuse |
    • Borque

      All natural whiskey? Drawn from pristine whiskey hot springs in Kentucky.

      June 1, 2012 at 14:31 | Report abuse |
    • peridot2

      Bad idea in so many ways. Would you give a vodka to a 5-year old child? No? You're giving alcohol to an infant. Same difference, not to mention it's illegal. In addition, most kids who use alcohol at an early age go on to become alcoholics. I am not making this up.

      Give the baby a frozen mini-bagel to chew. They're hard and the icy texture makes the swollen gums feel better. Plus, no chance they could form a craving for booze at an early age.

      June 3, 2012 at 12:41 | Report abuse |
    • Concerned

      Really? Why don't you just give them some opium? Even more all-natural, comes from a flower! In fact, if we are talking all natural cures, how about cyanide (peach pits, apple seeds), strychnine (comes from a tree), anthrax (comes from bacteria).

      To the person who wants to give babies honey, that is a leading cause of infant botulism, which causes paralysis and respiratory failure. The American Academy of Pediatrics does not recommend honey under 1 year old for that reason.

      June 3, 2012 at 22:41 | Report abuse |
    • Mel

      Underage drinking is not illegal with a parent. And rubbing it on a baby's gums isn't making them drink it. I personally didn't do it but I don't see anything wrong with it.

      June 7, 2012 at 11:28 | Report abuse |
  3. maryam

    In May 1994, my son who was just 5 months old and teething suffered a sudden onset of skin rash and blisters all over his extremities. I had applied Anbesol to his gum because he was having teething pain.
    We had to rush him to emergency room at San Francisco General.
    The doctors took pictures of his skin and told us that they had never seen anything like this before.
    The red blotches and blisters were an awful sight to look at on a baby's skin. Both my husband and I were crying and were told that our son may not live.
    He was in acute care for 3 days until he finally came out to a regular ward. They had to do a blood transfusion.
    My husband, myself, and 4 members of our family gave blood that matched his.
    We wrote to SmithKline Beecham, the company that made Anbesol about it.
    They never responded.
    We were just thankful that SF General saved our son's life.
    The doctor at SFGeneral said that it was blood poisoning due to Lidocaine (Benzoncaine) in the gel.

    June 1, 2012 at 13:18 | Report abuse | Reply
    • Sunflower

      No lawsuit??? I would have been furious.

      June 1, 2012 at 13:40 | Report abuse |
    • Spencer

      Just so you know, Lidocaine and Benzocaine are two distinct anesthetics. It is an amide anesthetic and Benzocaine is an ester anesthetic. Lidocaine is not usually used in teething gels.

      June 1, 2012 at 16:41 | Report abuse |
    • maryam

      Anbesol contained LIDOCAINE in 1994 when we bought it. The pharmaceutical companies may have changed the chemical to BENZOCAINE now but that's what it contained.

      June 1, 2012 at 17:10 | Report abuse |
    • babybear

      oh my, the poor kid. Glad he made it through.

      June 1, 2012 at 18:21 | Report abuse |
    • riley

      15 reported deaths in kids under 2 since 2006? I wonder how many kids have used this in over 5 years? What is the incidence rate?

      June 2, 2012 at 23:46 | Report abuse |
    • peridot2

      Had you been wise enough to have retained an attorney, it's guaranteed you would have received a response from them. If anything like this happens again, lawyer up.

      June 3, 2012 at 12:43 | Report abuse |
    • justathought

      Probably no chance of a lawsuit even if she had tried. I'm pretty sure it said on the package, "not for use in children under 2"

      June 4, 2012 at 13:13 | Report abuse |
  4. Angelique

    Of course, another thing we shouldn't be giving our kids. There's a brand that makes homeopathic teething tablets, they've been making them since 1945! Search for them, I thought they worked great for my son. I think it comes in gel form as well, but I liked the tablets better. You crush them up a bit and put them on their gums.

    June 1, 2012 at 13:18 | Report abuse | Reply
    • Concerned parent

      Yeah, we used it for our son too, it's called Calcria Phos. You can get it at GNC, and other vitamin shops or Target =)

      June 1, 2012 at 13:34 | Report abuse |
    • rpmi1640

      The teething tablets contain Belladonna, also known as deadly nightshade. They were withdrawn from the market due to safety concerns, but have been rereleased.

      June 1, 2012 at 14:24 | Report abuse |
    • MM Nurse

      how about just toughing it out for a while....very safe and all natural

      June 1, 2012 at 14:38 | Report abuse |
    • Julie

      We use the Humphrey's teething pellets for our son when his teething pain is bad enough to need it. They have belladonna and chamomile in them and work almost instantly. Several of our friends used them as well. none had any adverse reactions at all.

      June 1, 2012 at 15:52 | Report abuse |
    • AngiG

      I have used the tablets for my children too, but I know what they contain. You guys DO know that belladonna (nightshade) is used to make seizure medication? It can induce hallucinations, and in high enough doses, death.

      June 1, 2012 at 16:30 | Report abuse |
    • DAVID

      THEY'RE CALLED HYLANDS TEETHING TABLETS AND THEY DISSOLVE IN THE BABY'S MOUTH. ALL NATURAL. HYLANDS MAKES DIFFERENT ALL NATURAL PRODUCTS FOR BABIE'S ILLS.

      June 1, 2012 at 18:08 | Report abuse |
    • Allsixesandsevens

      MM NURSE is right: tough it out. Turn it into a bonding moment. Make them feel safe when they hurt instead of trying to cover up the pain with bizarre concoctions.

      Skip the gels, pills, and all the rest! Your kiddos will be fine.

      June 2, 2012 at 23:25 | Report abuse |
    • peridot2

      Baby Tylenol drops also work great when there's extreme pain. What's wrong with using real medicine?

      June 3, 2012 at 12:45 | Report abuse |
  5. MM Nurse

    sorry those tablets are still on the market and still contain belladonna

    June 1, 2012 at 14:39 | Report abuse | Reply
    • MamaBear

      They are homeopathic. If you look at how much they are dilluted they actually are just milk sugar really with only an infinitesimal traces of belladona, or caffea cruda, or chamomile. They contain almost no actual medication, they should do nothing, they should not work. And, they are not harmful. However, for some reason they work. My husband had a toothache some years ago. He was controlling it with sizable regular doses of ibuprofen. We were on a car trip and ran out. As a mild joke I handed him some teething tablets. He was flabbergasted when they worked immediately. In my opinion they are much less harmful than benzocaine based teething gels.

      June 2, 2012 at 22:41 | Report abuse |
  6. Ethic's Board

    Treated a kid with methemoglobinemia just last month. Nothing that a little Methylene Blue can't fix. That being said, I would never give my own child Orajel.

    June 1, 2012 at 14:47 | Report abuse | Reply
  7. onlyinamerica

    give your teething tot a cold wash cloth the chew on, put it in the freezer for a while first

    June 1, 2012 at 15:03 | Report abuse | Reply
    • Karl

      Yes, we did that too and it worked great. Rinse and squeeze out well a wash cloth (several times to make sure there is no soap residue) and then freeze. Our little ones loved them, especially for those top teeth.

      June 1, 2012 at 16:30 | Report abuse |
  8. Michelle

    Well, we did try the orajel for our daughter. We found it really hard to actually apply to the area affected. Its gloopy, she's crying and flaying and much to our distress she ended up swallowing most of it – not good! We found out, at a later visit, that our pediatrician didn't recommend any of these types of medications. Ultimately, we found that motrin works the best. She only needed in the evening and it guarenteed at least 6 hrs of sleep for all.

    June 1, 2012 at 15:25 | Report abuse | Reply
  9. 1tag2

    I bet a tincture made from a high CBD strain of cannabis would be sufficient for a toothache.

    June 1, 2012 at 15:29 | Report abuse | Reply
    • BILL

      Using a natural plant based remedy is an outrage. The DEA should have been handling this since it looks like a very rare
      allergy is affecting 30 people nation wide. Schedule One baby!!! The DEA knows all there is to know about weed. *cough **cough** yes I'm being sarcastic as can be.... I have some Everclear extract tumbling as we speak.

      June 2, 2012 at 02:06 | Report abuse |
  10. juice

    Teething is natural phenomon and happed for eons since the beginning of human race. I don't understand why people would take medicine if there's nothing wrong.

    June 1, 2012 at 16:00 | Report abuse | Reply
    • fdgarrett

      Okay, dying is natural and has been happening for eons too, doesnt mean we avoid attempts to intervene. As our understanding of things broadens, we learn how to intervene in suffering, especially as it concerns our little one. No, pain won't kill a kid, but if you can ease their suffering, that is what a parent will do.

      June 2, 2012 at 10:15 | Report abuse |
  11. kat

    i am glad i am not the only one who used "whiskey" LOL.... i did this w/my first one late at night when i had nothing on hand (thanks mom :) and old wives tales)...I have used HYLANDS teething tablets for both kids since then.... never did the Oragel thins....the gel stuff wears off once a liquid comes in contact w/it (ie salvia) were as hylands teething tablets don't (supposedly work through via the blood stream??) howeverit works i tell ALL NEW moms about HYLANDS brand

    June 1, 2012 at 16:01 | Report abuse | Reply
    • Heather

      Hylands contains belladonna– I definitely would opt for a little benzocaine rather than a "natural" hallucinogen.

      June 2, 2012 at 06:48 | Report abuse |
  12. forgetthis

    When my son was teething, we would give him the spine from lettuce leaves or fennel stalks to chew on. They were cooling to the gums.

    June 1, 2012 at 16:04 | Report abuse | Reply
    • DamLa

      First thanks for the conemmt on my blog. Yes, it is scary when something is wrong with your baby and you aren't sure what. My little guy actually doesn't go #2 (as my kids call it) for at least 2-3 days so he gets very irritable when the time comes and boy does he get gas. It's amazing how much that gas will keep them up. Hope your little one is feeling better now. Love that smiling pic of him.

      September 13, 2012 at 23:13 | Report abuse |
  13. OrangePekoe

    I can't imagine giving a kid anything containing Belladonna! BAD idea.

    June 1, 2012 at 16:08 | Report abuse | Reply
  14. mahdeealoo

    Hylands teething tabs are safer...

    June 1, 2012 at 16:10 | Report abuse | Reply
    • Safe Mom

      Actually, Hyland's Teething Tablets also carry major safety concerns. They contain Belladonna, which is a sedative. The amount of Belladonna can also vary and is not regulated by the FDA. This product was recalled because of the Belladonna at one point, somehow it has made it back on the shelves while still containing this dangerous ingredient.

      October 14, 2013 at 01:46 | Report abuse |
  15. peckbag

    Babies don't feel pain.

    June 1, 2012 at 16:20 | Report abuse | Reply
    • jane

      Excuse me did you say babies don't feel pain? Your comment is false big time...

      June 1, 2012 at 16:29 | Report abuse |
    • michelle

      Not sure what planet you live on but in the real world that I inhabit babies most definitely feel pain!

      June 1, 2012 at 18:17 | Report abuse |
    • Horticulturist

      No, Peckbag is quite correct. Studies have shown that babies, like plants, do not feel pain the way we do. If your baby is crying, it's probably just due to a lack of sunlight – put him/her out in the sun for a few hours (no sunscreen!) and the situation is sure to improve. In the winter months you can use a grow light in the nursery.

      June 2, 2012 at 09:03 | Report abuse |
  16. jane

    Please be careful with the teething tablets. There was a recall on them a few years back and I do not remember the brand, but the company was adding to much benzocaine. I still have them because I didnt want a refund, I kept it just in case so I had proof if something happened to my baby.

    June 1, 2012 at 16:33 | Report abuse | Reply
  17. pbernasc

    in million of years every single human has grown up without the need of baby pain gel .. for teething.
    Now suddenly one is supposed to alleviate such incredible growing up pain by using a non well defined chemical that the company who sells it, says it absolute harmless. YEAH RIGHT.

    I have two small kids .. one gong through such phase .. no thank you. We will not igve poison to our kid just because some marketing manager somewhere needs to make more money

    CRITICAL THINKING IS THE BIGGEST WEAKNESS OF THE AMERICAN PUBLIC, THEY HAVE NO SUCH THINKING AND BELIEVE ANY CRAP

    June 1, 2012 at 17:28 | Report abuse | Reply
  18. o g daddy

    give dem babies a pork chop bone n dey will go to town when dey teethin

    June 1, 2012 at 17:33 | Report abuse | Reply
  19. lrhughes

    Forget the gels, pills, or anything else for that matter; let the child gnaw on your finger, or even if that's too much for you as well, get a pacifier with your finger in it. I'm not all for the orajel stuff. That disappears in a matter of minutes. You can never have too much of either of those and thank goodness they can't cause these crazy skin diseases! Let your child gnaw on your finger and spend some time with them rather than saying "Here's some orajel, now go back to the babysitter the television!"

    June 1, 2012 at 17:33 | Report abuse | Reply
  20. vlatona

    Just wondering why the FDA doesn't yank these products off the market? Why issue a warning, particularly when it comes to babies! First they refuse to ban the use of BPA in America (when almost every other country has banned its use), and now this. What is wrong with the FDA?

    June 1, 2012 at 22:14 | Report abuse | Reply
    • TheReaperD

      What's wrong with the FDA is that they are owned in full by the pharmaceutical and petrochemical companies. It's a revolving door of industry managers being appointed by paid for politicians to the FDA, serving their term and returning to higher paying jobs at the company they used to work for. The same can be said for the DOJ, EPA, SEC and the rest of the alphabet soup. We have the best government money can buy!

      June 2, 2012 at 20:53 | Report abuse |
    • Drew

      You are so right... problem is that not that many people realize the truth in what you just posted.

      June 3, 2012 at 23:23 | Report abuse |
  21. Benny

    Exactly why I would stay up with and nurture my baby through the teething stage. Any chemical can generally be avoided. Relying on some chemicals beside fever reducer is laziness.

    June 2, 2012 at 01:12 | Report abuse | Reply
  22. BILL

    I don't enjoy pain and take Alleve, bong hits,Aspirin for relief. I understand teething is natual and yadda but a baby can't understand that and relief should be granted. Nuture when they fall and compound fracture the arm. Would you deny them pain meds then as well? 30 folks nation wide and adults are at risk as well. You have to weigh the options and perhaps stay away from something you are not comfortable with.

    June 2, 2012 at 02:12 | Report abuse | Reply
    • Heather

      I agree, Bill. I bet a lot of the people saying "Just let them chew on your finger!" had epidurals when they gave birth. Or ithey've taken Sudafed for their runny nose or Advil for their menstrual cramps. I have. And therefore I won't let my baby scream through his teething just because that's how babies used to do it.

      June 2, 2012 at 06:51 | Report abuse |
    • Drew

      29 caaes in 300 million people and big brother FDA is issuing warning.. Go to hell FDA.. there are so many other things killing people right now and you dont issue statements or try to ban them. Try sun screen, cigs, etc. But your gonna make a big deal out of the ora=gel..

      June 3, 2012 at 23:25 | Report abuse |
  23. Steven

    ive been an er nurse at a level one trauma center for almost 10 years and have only seen one case of this, and it was in an adult

    June 2, 2012 at 05:47 | Report abuse | Reply
  24. Fred Baldino

    This is the first I've heard about Benzocaine. I been fighting mouth sores for 13 years, after I had Chemotherapy for cancer. I'm sitting here right now (No JOKE), with a bottle of ambesol and a can of Hurricaine. I use it at least 12 times a day or more. I have also used a prescription Lidocaine mixture. I always thought it may not be good to use these products for long periods but I suffer terribly, with pain. I'm glad I didn't use much Baby Orajel on my son, when he was teething. My Dad used the good old Whiskey on my gums, if I had Whiskey in my house ,I probably would have used that on my son's gums. I learned something important today, I'm glad I read this article.

    June 2, 2012 at 08:03 | Report abuse | Reply
  25. Mike

    Before lawsuits this was good, afterwards, not so much...

    June 2, 2012 at 20:17 | Report abuse | Reply
  26. sacchrainkiss

    I'm glad I never used orajel, I kept a couple damp rags in the freezer and gave them to my daughter to chew on when she needed it. On the worst days I gave her some tylenol before bed. My father in law is a dentist and he told me that those products cause damage to existing teeth as well.

    June 2, 2012 at 20:54 | Report abuse | Reply
  27. KDW31

    This is ridiculous fear mongering. 29 deaths since 2006. That comes out to an average of 5 deaths a year. More children die in car accidents in a month than have died from using benzocaine in 6 years. I bet everyone is still going to get in their cars tomorrow, though.

    June 2, 2012 at 23:19 | Report abuse | Reply
  28. jean

    My 8 month old baby is teething and you know what I use Cold teething rings safe and no medicine, you don't always have to use these products to help your children....

    June 3, 2012 at 12:27 | Report abuse | Reply
  29. Mintmom

    Nursing works.

    June 4, 2012 at 03:10 | Report abuse | Reply
  30. aprilrayne9

    a lot of people forget that back in the day the cry it out method was ok for teething because most families had a stay at home parent. that means only one person needed sleep and the other dealt with taking care of the kids all night.

    another thing is that all those tricks may work when you have all yout time to focus on one child but when you have multiple children it becomes a balancing act. ive done the all night comforting for my infant and then had to wake up and take care of both her and my barely 2 yr old first child and thats exhausting and dangerous. more kids get hurt when the parent has little to no sleep. that being said.

    ive sometimes given my kids ibuprofen, teething tablets and teething gel all at the same time and that seemed like the only relief.

    it seems like everything that was done parenting wise in the past is horrible and everything im thinking im doing right now is turning into a, bad thing too. don't use orajel, dont use tylenol, dont let them have a bottle in crib at night, dont neglect them during teething but dont ease their pain either... so confusing. one minute i think im doing the right thing and thr next im not. its hard enough to be a mother and wife as it is! and its hard to take every article on dangerous stuff and trust that its not just a filler or if its a true proven danger. im so exhausted and confused :(

    June 4, 2012 at 13:07 | Report abuse | Reply
  31. Seola

    Yes and kids can die from drinking too much water, it's rare to get sick from and even rarer to die from but it happens. 29 cases in 6 years... 5 cases a year out of millions of tubes sold. It's a med – they all have chances of side effects. Nothing you eat, drink, ingest, etc. is risk free, from water, to potassium overdose from too many bananas (which happens more than this) to even eating too many tomatoes.

    I'm tired of overreactions to every single thing. I realize children die from rare cases but unless you want to just kill the kid to start with, anything can be "dangerous". The dropside crib fiasco should have taught us something. Out of 14 million cribs estimated in use, something like 14 children died from improper assembly. So what did they do? Banned them entirely. For a rate of less than .001%. Injury rate of something like >.01%. They modified some problem designs requiring metal pieces for the drop sides instead of plastic on the cribs that used it, less injury reported but one parent on a crusade got them banned for millions.

    Cold medicine for kids – another banned product because parents were ODing their kids because they'd not pay attention to dosage. A few deaths where a parent gave almost a whole bottle because they didn't know the difference between TSP and TBSP in a day, and a couple of reactions in the hospital and complete ban. Forget the other 99.9993% of parents that used it safely.

    Closer and closer to bubble houses and mandatory inspections of the home and a ban of all kids under 6 months in public.

    June 5, 2012 at 02:53 | Report abuse | Reply
  32. P

    It is hard for parents to see their child in pain when teething and easy to jump to an over the counter product, assuming it is safe to help alleviate pain. Baby orajel sounds safe to use, however, if FDA states and have found evidence that using benzocaine products can cause methemoglobinemia, as a PharmD candidate, I am not going to recommend it for oral use.

    June 7, 2012 at 11:44 | Report abuse | Reply
  33. Mike Jensen

    15 cases in children under 2 since 2006. Wow! How many millions of times a year do parents use these products with good results. More children are killed every year driving to the grocery store with their parents. "Warning: Driving your kids in a car can be fatal. We recommend that you avoid it." These federal government fear peddlers are not going to be happy until we're all shut-ins, afraid to go out and get the mail.

    June 7, 2012 at 18:52 | Report abuse | Reply
    • Tiniko

      Poor baby Wills, who obviously clduon't get the shot, has had it pretty bad. Coupled with heavy teething (his top two came out this week, and one more is breaking too), he's had a tough time. And so

      September 13, 2012 at 23:19 | Report abuse |
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  39. joseph boyer

    First and foremost, did the parents get tested to carry "Methemoglobinemia". Because you can carry it and never even get affected, but pass it on to your kid and bam... the have this problem. we need more info CNN

    November 27, 2013 at 06:46 | Report abuse | Reply
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      ONLY IF SWALLOWED in a heavy amount. parents need to use a really small amount. good rule to fallow use it on yourself and see how much it takes to numb a small area. and Use ONLY THE CREAM on babys. AND DONT PUT IT ON TOYS THEY TEETH ON.

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