Scott, my husband, works for the FDA. He’s always been a bit (sometimes a lot) paranoid. His OCD tendencies are a running joke around here. Friends are tentative to invite us over for dinner for fear he won’t think the meat is cooked to temp or he might spy some cross contamination. I often have to reel him back to reality, reminding him that germs aren’t always a bad thing, and that he, in fact, survived many of the things he tries so hard to prevent Kendall from coming into contact with.
Pregnancy is always an especially trying time because, in his effort to protect his unborn child, he becomes even more obsessed with the things I put in my body. It drives me nuts, mainly because I hate to be told what to do. I know his intentions are good, and I try to look at it from his side, but I’m not a crack whore. It’s not like I’m huffing paint.
I can’t blame the guy, though. It’s his JOB. You can’t see what he sees and know what he knows and not react this way. I get that. And I’ll admit my natural instinct to challenge authority causes me to balk at his suggestions more than I should. (Though there really are sometimes that he’s completely lost it, and I need to straight up tell him that if he asks me one more time if I washed the grapes before I ate them I’m going to cut off his balls… or I just neglect to tell him about how Kendall licked the bottom of some other kid’s shoes at the Chick Fil A playground.)
Well, in case you haven’t heard, The FDA has issued a Consumer Safety Alert for Hyland’s Teething Tablets, stating,
Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.
Back when Kendall was beginning to teeth, and consequently become possessed, I was desperate for any sort of relief. These tablets got rave reviews across all the mommy message boards and from anyone I asked face to face. My pediatrician even said they were worth a shot. Scott, however, was not convinced. He didn’t like that they were a homeopathic, not as tightly regulated substance. “How bad could they be?!” I argued. Why oh why couldn’t he just chill and let me give the kid the damn magic tablets? EVERYONE else was doing it, it seemed. I was convinced he was overly paranoid once again. Hell, at least I wasn’t seriously considering the “whiskey on the gums” advice everyone over the age of 40 was telling me.
Well, he was right, and that sucks. That sucks because that means kids got sick off this stuff. And as much as I hate to eat crow, I apologized to Scott tonight. He wasn’t surprised to hear about the recall and advisory (he doesn’t hear about all of this stuff before it’s public since he’s on the food end of things), and, unlike how I may have reacted, he wasn’t “I told you so” at all about it. I know, though, that he’s storing this little win in his back pocket. The next time I want to give one of the kids some wonder-drug, I just know he’s going to remind me of the teething tablet debacle… and maybe he’ll be right… and maybe I’ll not put up such a big fight.
Hyland’s Teething Tablets have issued a voluntary recall. Check here for more info.
- 4Shares
25 comments
I saw your post on Twitter . . . I just wrote a post about this today: http://www.mamaeve.com/index.php/caring-for-baby-a-toddler/alternative-healthcare/199
Even though there’s a recall, there’s not much of an explanation about why. I don’t think a blanket “homeopathics are bad” or “hyland’s is bad” is the way to go on this one. A recall can happen for many reasons, and I think this needs a lot more information before judgment is made.
ugh- this does suck. for both reasons 😉
I also have friends who swear by the things… and it sucks because hylands actually seems to really try to do a good thing offering homeopathic stuff for kids rather than a bunch of chemical stuff… hopefully it all gets straightened out soon and that no kids were very sick off them. (I havent read the story since my kids are past teething age.)
I agree that this sucks! A.) Having to say you’re sorry and admit you’re wrong is never fun, and b.) it sucks they’ve taken them off the market because they’re awesome, and the amount of them that would need to be consumed before any potential adverse effects could be seen is in the thousands. Seems pretty silly to me….
No offense to Scott and his job, but I think the heads of the FDA rarely care about our health. They’re owned and operated by pharmaceutical lobbyists.
Here’s a (largely biased) alternative perspective. http://gaia-health.com/articles301/000321-fda-bans-hylands-homeopathic-teething-product.shtml
If they’re on the market, I’ll keep using them. Like they said, it takes a 10 lb child eating SIX bottles to see any adverse effect. That’s the point of homeopathy. Jonas ate a whole bottle while I was in the shower one day and when I called poison control they said “Hylands? It’s fine.” I asked if I should even go to the doctor just-in-case, and they said no.
I’d say the only reason the FDA doesn’t regulate homeopathy is that there’s zero dollars in natural remedies. You may have eaten crow a little too soon. 🙂
i totally agree with you here!!! Amen 🙂
You nailed it! Oh yeah!!
Kudos on being humble in your marriage and loving on your husband even when it isn’t fun!! It is a good reminder for all of us.
I am totally panicked about this and haven’t known what to post about it on my blog. I’m kinda with Gina in that I still don’t see what is wrong with Hyland’s, I knew it had small amounts of belladonna. We have never had issues with Hyland’s, I am VERY careful about how many I let Little Sir have within a 24 hour period (never more than 6).
I have a 1-year-old who is teething constantly and am about to have baby #2 who will also start teething and Hylands have been a LIFESAVER so far. I really cannot make myself be OK with feeding my children ibuprofen 24/7.
If anyone hears of any alternatives…I am open to them. I went out and bought 3 bottles yesterday before they pulled them off the shelves to stock up!!
I think the timing of this is SO freaky. I mean, I bought a bottle of these for the first time a couple months ago when my baby was really miserable from teething. I put them away the other day and hadn’t given another thought to them for a month.
Then he seemed miserable yesterday morning so I found the bottle and gave him the recommended dose of 3 pills. I then hopped on twitter and the blog world to find that they had just been recalled. Lovely.
He went to sleep shortly after I gave them to him and I was like a bird hovering over him, making sure he was still breathing. It REALLY freaked me out.
He’s still alive but I still threw the bottle away 🙂
We have a family friend who works for for the health department inspecting restarunts. Consequently we don’t eat out. Fun, no? As for Hylands. . . it’s so hard! I, too used them knowing they contained belladonna. I considered it better than the whiskey on the gums as well. Now? Maybe not so much.
So, without any proof of any sort—not even an attempt to find any proof—the FDA decided that Hyland’s Teething Tablets should be banned. They don’t even provide any estimate as to the amount of the product that would have to be ingested to cause harm. That, of course, is because they don’t care.
Not one shred of evidence is given that the product is dangerous, which isn’t surprising, because it would take an incredible quantity to cause even the mildest adverse effect. Yet, the FDA panders to fear by suggesting that parents consult with a “health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.”
They imply that children have been harmed because they’ve “received reports of children who consumed more tablets than recommended”. Notice that they don’t say how many, nor do they even try to indicate whether they’ve found any connection between the tablets and the possible symptoms. Here’s why:
It would take ingestion of at least a thousand tablets by a ten-pound child to see even the first hint of a negative response. That’s at least six bottles—and even this is an extremely conservative figure.
Why would the FDA target Belladonna? Here’s why ..
Many pharmaceuticals utilize a Belladonna derivative, atropine, as an antispasmodic. A typical potency is 0.4 – 0.8 milligrams per pill(1). In this form, it can be effective, but it also carries serious risks. In contrast, the amount of Belladonna in the Hyland’s formulation is a mere 0.0002 milligrams per pill. A single pill of the pharmacy formulation is 2,000 to 4,000 times stronger!
WAKE UP PEOPLE !! The FDA is stealing your right to use safe products. Remember, the FDA says you have no right to health—and they mean it. Research Codex Alimentatarius..
Wake up people !! The FDA is stealing your right to use safe products. Remember, the FDA says you have no right to health—and they mean it.
http://gaia-health.com/articles301/000321-fda-bans-hylands-homeopathic-teething-product.shtml
So, without any proof of any sort—not even an attempt to find any proof—the FDA decided that Hyland’s Teething Tablets should be banned. They don’t even provide any estimate as to the amount of the product that would have to be ingested to cause harm. That, of course, is because they don’t care.
Why would the FDA target Belladonna? Here’s why…
Many pharmaceuticals utilize a Belladonna derivative, atropine, as an antispasmodic. A typical potency is 0.4 – 0.8 milligrams per pill(1). In this form, it can be effective, but it also carries serious risks. In contrast, the amount of Belladonna in the Hyland’s formulation is a mere 0.0002 milligrams per pill. A single pill of the pharmacy formulation is 2,000 to 4,000 times stronger!
Research Codex Alimentarius
About two weeks ago my mother asked me if I used these with my daughter. I hadn’t because I’m probably just as paranoid about things as your husband (annoying, I know!). She told me that a woman she works woth actually lost her son to those pills. I just figured it was a freak accident (like maybe he was allergic or something)…anyways, you never know. I’m not saying it happened because of the Belladonna issue, but it is a coincidence that it happened so close to a recall. Devastating either way.
I’m curious if he was worried about the “tightly regulated substances”?
Did he apologize to you when the FDA recalled 43 OTC Pediatric Medications earlier this year?
I don’t think people should use homeopathy without understanding how it works (by default, ingredients).
If ANY products have varying degrees of ingredients, that’s a problem. I am glad that Hylands is addressing this.
I don’t think that this problem in particular makes them dangerous or anything close.
@Melissa – I have a hard time believing that (NOT you, but the information). If a child had died, THAT information would be all over the place.
I think it was amazingly graceful of you to apologize to your husband and what a lesson in humility. Thank You.
THANK YOU, Thank YOU, THANK You for removing that MF’ing pig!!
My husband is much like yours. A paranoid Pauly!
We live near Fort Detrieck and when we moved here he seriously sat me down and told me that in case of a chemical attack I needed to get in the fridge.
He is constantly on alert about the strangest things. But I’ve found myself apologizing for laughing at him when some of his predictions come (kind of) true.
The amount of belladonna is ridiculously low. People just don’t understand homeopathics in this country. How many recalls have tylenol and motrin gone through? how much of those otc meds would it take to harm a child?
Here are the active ingredients:
Calcarea Phosphorica 3X HPUS; Chamomilla 3X HPUS; Coffea Cruda 3X HPUS; Belladonna 3X HPUS (0.0003% Alkaloids)
the amount of Belladonna is .0000003%.
Each “x” value (according to poison control) = 10 fold dilution.
Hylands explains as follows:
“As a homeopathic medicine Belladonna is made from the whole plant, which is then diluted to 1 part per 1000 in the preparation of the Teething Tablets, resulting in the homeopathic potency of 3X HPUS. The manufacturing process for homeopathic Belladonna is regulated by the FDA and precisely detailed in a monograph in the HPUS (Homeopathic Pharmacopeia of the United States). Prepared in this way only 0.0003% of the tablet is the toxic Belladonna alkaloids (a fact that we do state on the label). The 3-step dilution process of the Belladonna plant creates a very large margin of safety for the Teething Tablets, as a 10 pound child would need to ingest 6 full bottles of 125 tablets before possibly seeing the first side effect of dry mouth.”
and regarding the caffeine:
“The homeopathic medicine Coffea Cruda 3X is also an ingredient in the Teething Tablets. Coffea cruda is made from the whole unroasted coffea bean, and is processed by diluting the beans 1 part per 10 in lactose serially three times. This results in a final concentration of 1 part per thousand, or 0.064 mg per tablet of coffea cruda.
Coffea cruda contains “up to 2% caffeine alkaloids”, therefore the Teething Tablets contain ‘up to 0.00128 mg caffeine per tablet’. This quantity is not enough to cause any central nervous system stimulation that we associate with drinking a cup of coffee (which contains 100-300 mg of caffeine). When caffeine is used as a stimulant in infants by conventional medicine, the dose is 5 mg per kg of body weight.”
You can do the math yourself, or call poison control (we did, to verify lol!)
FWIW, Poison control commented that it only takes 1/4 teasp of orajel in children under a year to send them the ER – and 1/2 teasp in kiddos 12 mo to 2 or 3 y/o depending on weight – so if the child got ahold of the orajel and ingested the tube, it’d be much more concerning than eating an entire bottle of hylands teething tablets. ?
Fully agree with Orajel. Our peds are highly against it becasue it relaxes the throat muscles causing a chance of choking/eating problems.
Wow. Sorry I haven’t been on to respond to comments on this one just yet. I’m just going to say that I can understand the upset over the recall, and I get what a lot of you are saying about the low levels of Belladonna. Speaking for MYSELF, I’ll just say that I’m uncomfortable with the *inconsistent* levels highlighted by the Consumer Safety Alert.
Unfortunately, I can not speak at all to the questions re: my husband and his professional opinion and/or the opinion of the FDA.
You know, I’d always thought that “homeopathic” just meant “herbal” or “natural” or things along those lines (and I think a lot of people operate under the same misconception). It wasn’t until recently that someone had me actually look up the principles behind homeopathy and I’m more than a little embarrassed that I ever spent money on any company peddling that level of absurd quackery, and downright pissed at myself for giving the stuff to my daughter without doing my homework first.
The teething tabs never did anything for my daughter beyond her really liking the sweet taste and wanting to chow down on more of them. I’m glad I resisted that urge and kept them out of reach.
Jenna – I am a bit confused by you being embarrassed?
What in homeopathy isn’t “natural”?
Everything can be dangerous, even “natural”, depending on conditions, etc.. Like water toxicity – you can drink too much water too quickly and die.
As a comparison, here’s what’s in Infant Tylenol:
http://www.tylenol.com/product_detail.jhtml;jsessionid=TPJSCINBVADHICQPCCFSUYYKB2IIQNSC?id=tylenol/children/prod_inf.inc&prod=subpinf&_requestid=1130301#
Here’s what’s in Hyland’s Teething Tablets (under Formula):
http://www.hylands.com/products/teething.php
I am surprised and pleased that many of the people who read this blog feel about the FDA as I do.
What a ridiculous recall. Fortunately most of us do research before giving our child anything, and don’t depend on corrupt institutions such as the FDA to make our decisions for us.
The fact that part of the recall mentions that the teething tablets aren’t in a childproof container just makes me shake my head. COME ON. Your child would be worse off consuming any of the other things in your house that aren’t child-proof–nail polish, toothpaste, shaving cream, shampoo, etc., if you’re dumb enough to leave them within reach.
@ Jenna,
If the teething tablets didn’t work for your daughter, it means you had the wrong remedy. Homeopathics are to conventional medicine what Latin is to English. There are so many things to learn, and a new way of thinking before you understand them. I have a good friend who is a skeptic like yourself,and all I tell her is “You don’t have to believe in them for them to work”.
Remedies composed of different substances such as the teething tabs are designed to work for the majority of cases. However, single remedies, when properly chosen, will usually work better, although not for every person. For instance, when my daughter was teething, my homeopath (also an MD) suggested pulsatilla for “clingy and teething” and chamomilla for “Angry and teething”. You don’t just look at the “diagnosis” as you would in conventional medicine, you also look at the emotional and mental state of the child or adult you are treating. Sounds crazy? Maybe, but I’ve seen homeopathics successfully treat everything from postpartum pain, to viruses, to bumps and bruises.
Recently my youngest daughter, only 4 months, was basically catapulted from her car seat face first onto the sidewalk. (Due to a Daddy oops and a overly loving three year old) Instantly there were bruises forming on her face, but I got out arnica, the remedy for bruising and inflammation, and started giving it to her every hour. The next day, she was perfectly fine, and even her scabs off her nose were gone. Arnica is also a postpartum mom’s best friend!
Last winter, during the H1N1 scare, I was pregnant. I decided not to be vaccinated for H1N1 and was exposed many time, including sending the day with my mother the day before she showed symptoms. Because I was on homeopathic prophylaxis to boost my immune system, I did not get sick, and was healthier that winter than usual!
Another doctor told me that the more we understand about quantum physics, the more homeopathy makes sense. Interesting. I think the more people research into homeopathy and how it works, the healthier we will be. I also think it’s pretty sad that drugs like Vioxx will kill hundreds of people before they are recalled, whereas the teething tabs are recalled because they might pose a risk.
“The fact that part of the recall mentions that the teething tablets aren’t in a childproof container just makes me shake my head. COME ON. Your child would be worse off consuming any of the other things in your house that aren’t child-proof–nail polish, toothpaste, shaving cream, shampoo, etc., if you’re dumb enough to leave them within reach.”
I agree.
Maybe they should do a mass recall on knives, cause if you are stupid enough to let your child get to them without supervision, they could get hurt.
As with anything, homeopathy is great if you use it properly. Anything in excess is dangerous. I have three kids and have used these teething tablets with all of them, and am bummed they are pulling them.
If they want to protect the public from problems, they should spend more of their time and money educating the stupid people. Let us make our own decisions.
You do not owe him an apology for this; i do believe it is quite the other way around.
p.s. This “debacle” doesn’t belong to Hyland’s; it belongs to the FDA.
I personally think that everyone is over-reacting a little. Both of my kids have taken them for teething and they are just fine. They only finished one and a half bottles each throughout their entire teething periods – 125 tablet bottles. I think the onus is on the parents for using way too many pills. There is certainly no need to go over the maximum dosage per day and there is nothing there saying that you have to give your child the max dose. If it takes six bottles for adverse affects to show, then I would consider mine and any other responsible parents children safe. I am truly sorry if any child had to suffer due to an overdose.
On another note. They are still selling the Hylands topical gel that you apply right to the gums. It must be regulated better. Anyways, if you like homeopathic or Hylands products, than there are still options. I personally don’t want to put anything in my kids mouth that is found in the drug store, so I guess I will stick to cloves.