Halloween Safety, Toddler ADHD, Stevens-Johnson Syndrome – PediaCast 135
- Halloween News: Safety Tips, Allergic Reactions, Candy Gorging
- Breast-Feeding and Guilt
- Toddler ADHD
- Extra Thumb
- Girl Blind From Motrin?
- Stevens-Johnson Syndrome
- Halloween Safety Tips
- Trick-Or-Treat Your Way To An Allergy-Free Halloween
- Never Fear: It's Ok To Let Your Kids Gorge On Candy This Halloween
- Girl Blind From Motrin? (News Article)
Dr. Mike Patrick: A warm thanks goes out to the good folks at Audiblekids.com for being one of our sponsors today on PediaCast. Be sure to visit Audiblekids.com/pediacast to download a free audio book today.
Bandwidth for PediaCast is provided by Nationwide Children's Hospital. "For every child, for every reason."
Hello, everyone! This is Dr. Mike coming to you from Brand Spankin' New Summerland Studio. That's right. No more Birdhouse Studio. We are coming to you from Summerland now in the heart of Florida. We're finally all moved, folks.
OK. There's still lots of boxes and we're in a rental house now because we're building a house, which by the way the plumbing was laid in the dirt a couple of days ago, still waiting on the concrete pad to be poured. So it's fun.
But we're living out of boxes. We don't have any paintings or pictures on the walls. We're going to be here six months. I don't know. It just seems silly to unpack everything. So we've got the essentials unpacked. We've set shop.
Things are going well and I am pleased to tell you that we are back doing weekly shows.
OK? Weekly, you heard me right. No more of this "every two weeks" and "every three weeks," "maybe once a month". We are back coming at you once a week. I'm excited about that.
What are we going to talk about today? Well, it's the middle of October. I think we'd better get something in there about "Halloween Safety". Lots of trick-or-treaters are going to be going out there.
Not just safety, like watch for cars and make sure you're wearing reflective clothing, but what about allergies? Food allergies? Got to think about that, that's part of Halloween safety. I mean, if you've got a kid who's allergic to peanuts, you don't want them accidentally getting something with peanuts in it, right?
So we're going to talk about that and other aspects of Halloween Safety including a little perspective from the dental folks. What do they have to say? The answer to that actually might surprise you.
Toddler ADHD – is there even such a thing? Can toddlers have ADHD?
Or is it just all behavioral issues? We're going to talk about that and finally, Stevens-Johnson syndrome. It's a really bad thing and there was something in the news recently about a little girl who became blind because of Stevens-Johnson syndrome.
It was all started with the Children's Motrin. So is Children's Motrin something you should throw out of your house, or is it safe to use? We're going to discuss that as well.
And of course, we also have lots of News Parents Can Use coming your way, as we always do. So that's also exciting.
I'm excited. I'm excited because it's been a while since we've put one of these shows out. I did like the last two or three shows, before we left Ohio, and I did them all the same week, which was actually two or three weeks before we left and then we've been down here two or three weeks.
So it's been like six weeks since I've done a new show. I'm just itchin' to get this one going.
So I'm glad all of you took the time out of your busy days to join us. We, of course, always really do appreciate that. Most of the topics that we discuss here on PediaCast actually come from you.
So if there is a topic that you would like us to talk about, it's really easy to get a hold of me. Just go to pediacast.org and click on the Contact link. You can also email firstname.lastname@example.org or call the voice line and leave us a message with your question or your comment at 347-404-KIDS or 5437 – those last numbers if you don't have letters on your telephone buttons.
One more thing I have to say. If you are having trouble with Episodes 132, 133, 134 – so that would be the last three episodes – the ones I put together really fast.
There was a little glitch in those. I tried to get fancy. It's the bottom line. And we're going to switch the format to AAC so we can have chapters and basically enhance podcast.
But we ran into some problems with our advertising inserts and basically it was causing iPods to reboot. So I'm sorry about that, folks. If you're having trouble, if you haven't figured this out, the whole feed is back to MP3.
So if you had trouble with 132, 133 and 134, what you should do is "unsubscribe" briefly [Laughter] in iTunes. If you don't have a subscription then you just want to "delete" Episodes 132, 133 and 134 and re-download them and that should get you the MP3 version instead of the AAC version.
And for those of you who are with iTunes, you want to unsubscribe. Delete 132, 133 and 134 from your iTunes library and from your hard disk, too. No reason for those to take up space. And then re-subscribe and tell iTunes you want to re-download 132, 133, 134 then you should be back in business with those three episodes.
And I do offer my most humble apologies for the problem that we had with that.
All right. So let's go ahead and get started. Before we do, I have to remind you that the information presented in PediaCast is for general educational purposes only. We do not diagnose specific medical conditions or anything like that. Do you know what I mean?
We don't formulate treatment plans. We're not a medical office here, folks. If you have a concern about your child's health that is pressing, you need to call your doctor and arrange a face-to-face interview and hands-on physical examination.
And with all that in mind, we will be back with News Parents Can Use, right after this short break.
Our News Parents Can Use is brought to you in conjunction with news partner, Medical News Today, the largest independent health and medical news website. You can visit them online at medicalnewstoday.com.
Very shortly, trick-or-treaters will be heading the streets and heading to your doorstep. Here's some tips on how. You can not only have a happy Halloween but a safe one as well.
"Battery-powered jack-o-lanterns are much safer to use than real candles and a carved pumpkin. However, if you just have to use those real candles, keep them away from those trick-or-treaters," says Dr. Jennifer Zimmer at Baylor Regional Medical Center at Plano, Texas.
And one more fire tip, make sure paper and cloth yard decorations like ghosts, pumpkins and witches won't be blowing into flaming candles.
Also remember to move flower pots, water hoses, ladders and other tools out of the way so costumed kids won't trip, fall and get injured.
If you're driving out on a Halloween, of course, take it slow. Watch for kids darting from between parked cars. And if you're heading to a party, don't wear a mask while driving because you need your peripheral vision.
And one last tip from Dr. Zimmer: Children of all ages should be chaperoned while they're trick-or-treating and when you get home, remember to remove suspicious or open candy from their bag of goodies.
And now word regarding Halloween candy and diabetes. As all the little ghosts and goblins head out for an evening of trick-or-treating, out come the candy dishes. But who really, really needs to avoid the sweets?
Well, there are nearly 21 million children and adults in the United States who have diabetes, which represents 7% of the population.
Diabetes is a disease in which the body cannot regulate the amount of sugar in the blood. The incidence of diabetes is on the rise and experts believe the increase is due to many factors. The most significant of which is increasing obesity rates and the prevalence of sedentary lifestyles.
Many cases of diabetes can be controlled with exercise and proper diet even on Halloween. About 1.5 million new cases of diabetes will occur each year. And according to the most recent data by the American Diabetic Association, the disease contributes to over 200,000 deaths per year.
"If you have diabetes, stay away from Halloween candy," so says Elizabeth Schaub, a dietician and certified diabetes counsellor on the staff at Baylor Regional Medical Center at Plano.
If you're looking for an alternative handout this Halloween, try non-food treats such as plastic spiders, Halloween monster finger puppets and stickers. And remember says Ms Schaub, "whether you have diabetes or not, eating too much sugar and junk food is never good even on Halloween."
Food allergy is another point to consider. With Halloween right around the corner and with millions of children preparing to sport those costumes for school parties and a night of trick-or-treating, those with food allergies must take extra precaution.
The American Academy of Allergy, Asthma and Immunology asked children and parents to watch out for hidden foods that could trigger a life-threatening allergic reaction called anaphylaxis.
Food-related anaphylaxis leads to 150 to 200 deaths each year so every exposure should be taken seriously. Peanuts, tree nuts, eggs, milk, and soya are the most common causes of food allergies in children.
Eating even a small amount of these foods could trigger anaphylaxis. Symptoms of anaphylaxis include severe headache, nausea and vomiting, sneezing and coughing, hives, swelling of the lips, tongue and throat, and itching all over the body.
The most dangerous symptoms include difficulty breathing, a drop in blood pressure and shock – all of which can be fatal.
If any of these symptoms occur, use the child's self-injectable Epinephrine pen, if it's allowable. And if your child suffers from these types of allergies, their EpiPen should always be current and immediately available even when they're out trick-or-treating.
After using the EpiPen, request emergency assistance by dialling 911 or your local emergency number.
Even if the EpiPen appears to have worked, because once the epinephrine wears off, the life-threatening symptoms might suddenly return.
Here's some more healthful Halloween tips to avoid hidden food dangers:
When classroom parties are planned, the parents can help by packing treats from home known to be safe for their food-allergic child to eat.
Create a candy swap with siblings or friends so allergen-containing candies can be traded for other treats such as stickers or toys or candy that they can eat.
Take the focus off trick-or-treating by hosting a costume party that emphasizes fun instead of candy. Again, Halloween stickers, pencils, spider rings, and stamps are great alternatives for goodie bags.
And I don't know about you. When I was kid, you go to this whoop-up, a neighbor's party and there was always a lot of fun stuff to do. I remember you blindfold and you fill different food products – the peeled grapes are like the eyeballs and spaghetti as – and I don't remember now.
What could spaghetti be?
Wouldn't really be intestines? Just muck. OK. Oh, jelly-o for a brain. Did you ever do that? That was kind of fun. OK. I got side tracked. I'm sorry.
You can also provide neighbors with allergy-safe candies for your children so that your neighbors have something to give your child. I don't know. See, you can provide them that's fun. In this article recommended that you ask your neighbors to provide the allergen-free candies.
I don't know. To tell your neighbor what's safe to buy and not buy for your child, when they're looking out after the whole neighborhood. I don't know. That seems a little presumptuous to me.
Yeah, you can provide the neighbors with allergy-safe candies for your child. That would be fine to do. Although then you got to buy a bunch of different bags. I don't know. To swap things sounds like a better idea to me.
Teach your child to politely refuse offers of cookies and other homemade treats whose ingredients are unknown and you might want to not…
You might now want to take the cookies and homemade treats from people you don't know, either. That wasn't in the article but could have been added. Maybe should have been added.
Also remember candy ingredients can vary for different sizes of the same products such as the full size candy bar versus the miniature version, which the miniature version is not always individually labelled and may have a slightly different ingredient list. So keep that in mind as well.
OK and finally, some perspective on Halloween from the dental community which might surprise you. Of course, Halloween can present a very scary time of year for parents concerned about their child's oral health.
Megan Chiplock says when her daughters go trick or treating, they come back with a pretty big haul – and she lets them enjoy as much as they want.
"We let them go at it, gorge themselves and maybe for a few days afterwards if they want a piece here and there," she says that's fine. "But they really get their fill on Halloween night and then it's sort of out of their system."
Temple University Pediatric Dentist Mark Helpin says that might not be such a bad idea.
"The frequency of eating candy, and other refined carbohydrates, and their stickiness, are big factors in creating cavities," he says.
Eating carbohydrates can change the pH balance of the mouth, making it more acidic, which can increase the risk of decay. Each time candy is eaten, the acid environment in the mouth can take up to an hour to dissipate.
"So, if I eat a piece of candy now, the pH in my mouth will become acidic, and it will take 30 to 60 minutes for it to become normal," says Helpin. "If I keep eating candy throughout the day, there is acid in my mouth for much longer period of time and the longer the teeth are in an acid environment, the greater the risk they will become decayed."
Helpin, who is the acting chair of Pediatric Dentistry at Temple's Maurice H. Kornberg School of Dentistry says that there are a number of ways parents can minimize this risk while still letting their children enjoy the holiday.
"Parents can let their kids eat a bunch of candy now and a bunch later. But don't let them have one piece now, then an hour later let them have another piece," he said, adding that candy can also be dispensed as a desserts or snacks at meal time.
And meals are a good time at which to eat the treats as dessert because the production of saliva increases, which helps to wash away the acidity in the mouth.
Helpin also recommends parents have their children brush their teeth after eating candy, or if that's not possible, instruct kids to rinse their mouth with water three or four times after eating, which will help reduce acidity in the mouth.
Dr. Helpin warns substituting small bags of chips or pretzels for candy doesn't really solve the cavity problem. Chips and pretzels are also carbohydrates and they will also create an acid environment that can create cavities.
When trick-or-treaters come to his door, Dr. Helpin likes to give out sugar-free candy and avoids the sticky, gummy ones.
Megan says her kids don't really go for those sticky treats. "My three-year-old doesn't enjoy the chewy candy," she said. "She's tried them but they just get stuck in her teeth."
Ultimately, "it's not realistic to think you can tell your child you can't have candy, cookies, cakes, or other treats, especially on Halloween," says Helpin.
"Those are things most people enjoy and we want our kids to enjoy life."
So there's a dentist when some common sense, I think.
All right. So that wraps up our News segment. I have to apologize a little bit. I know I stumbled around some of those articles. As my brain went flying in one direction or another, I kind of stop and add a lot of things.
But hey, I'm a little rusty. It's been a while since I've done this. But we're back in the groove.
We're going to take another quick break and we will back to answer your questions and go over your comments, right after this.
I want to take a few second to tell you about one of our sponsors today, AudibleKids.com. AudibleKids is a one-of-a-kind community of parents, educators and their children with a shared interest in igniting a young person's love of reading through digital audio books.
Audiblekids.com offers 3,500 titles from over 75 publishers and many of them are unabridged. You'll find classics like the "Chronicles of Narnia," "Doctor Dolittle" and "Treasure Island," their 50 Newbery award winners including "Hoot," "Holes," and "Surviving the Applewhites". And of course, there are many, many more.
Teachers, literacy experts and a growing number of parents understand that audio books have long been a powerful means to develop a child's passion and enjoyment of books, helping them to develop confidence and interest in reading while sharpening listening and other literacy skills, which means, AudibleKids.com can turn your child's MP3 player into a valuable learning tool.
You can't go wrong with AudibleKids.com because it's brought to you by the good folks at Audible.com. And I've had a membership with Audible since 2001 so I can personally vouch for their outstanding value and customer support.
Be sure to visit Audiblekids.com/pediacast and we'll throw in a free audio book to get you started. But you have to hurry because this offer won't last forever. Audiblekids.com making books fun for kids of all ages and helping PediaCast out along the way.
All right. We are back and ready for our Listener segment. And first up is Sara from East Lansing, Michigan.
Sara says, "Dr. Mike, thanks for all the great info. I'm a mom of a seven-month girl and went through all the crazy new mom stuff, but I deny being crazy any longer."
"I just recently found your podcast, thanks Manic Mommies and Jumpin' Monkeys. I have found your podcast to be interesting, entertaining and it has reinforced everything our pediatrician has told us."
"I especially wanted to thank you for your comments on breastfeeding and the fact that mom's who stopped shouldn't feel guilty about it."
"My daughter was born with a minor omphalocele and was in the NICU for two weeks following birth because of the surgery to correct the birth defect."
"It was important that she be fed in a manner that allowed the doctors to monitor for food intake. This meant no breastfeeding. Once I had her home, she was rather attached to the bottle and nursing her was difficult though I really wanted to do it."
"After so much time pumping in the hospital and such difficulty nursing, once she was home I had a very negative psychological association with the whole business. My supply diminished quickly and within three weeks I was unable to nurse or pump any longer. I felt defeated like I had failed to give my new baby the one thing I and only I could give her."
"Hearing you say it's OK helped out a lot. Not sure if you'll read this on the show but if you do I'd like to give a shoutout to my two favorite pediatricians aside from you, of course, Dr. Courtney Hart and Dr. Baumgartner also known as Aunt Nikki."
"Yours as a noble profession and the world deserves more great doctors like the three of you."
Well, thanks, Sara. That's really kind. I really appreciate the feedback. And I think your comments really illustrate the point better than any words that I could string together. But I'm going to give it a try here because I did take quite a bit of flack from some folks, for chastising the folks who are, as I called it, Breast Nazis or people who are breast militant about breastfeeding.
People don't like those words and probably; if you're offended by those words [Laughter] the word probably describe you. Do you know what I'm saying?
So there are people out there though who think that in any situation, the parents have to breastfeed or you're a bad mom. I want to start by saying I still think that breast milk is best for babies.
And in a perfect world, all babies would get their mother's milk until they transition from babyhood to toddlerhood. But it's not a perfect world. And there are many situations, in which breastfeeding is simply doomed to fail.
Sara tells us about one of those situations. But of course there are countless others. And while, again, I subscribe to the philosophy that breast milk is best for most kids. There are a lot of other Sara's out there whose lives are miserable because of the guilt instilled by those of the breastfed-come-hell-or-high-water camp.
So I think the right message from me and all the Sara's out there to you, militant types, is just please lighten up.
OK. Next up we have Cecilla from Fort Smith, Arkansas and Cecilla says, "I have two questions. My first question concerns my almost four-year-old who is very rambunctious. Both sets of grandparents have said he may have ADD."
"Is this possible or it's just part of his age? I also want to mention that my mother-in-law who has six children claims all of them have ADD and she's medicated them for it."
"And she looks down on me for not doing the same."
"My second question is about my daughter who was born last December. She has two thumbs on her left hand. The doctors all said this is pretty common. Is it really? Would you have it removed and why?"
"Is it just for social reasons or for medical ones? Thanks for the show. I enjoy it and good luck with your move. Cecilla, Fort Smith, Arkansas."
So thanks for writing in, Cecilla. We'll tackle both questions here for you. First, your three going on four-year-old son is a wild guy. So does this mean he has ADHD? And if so, should he be placed on medicine and which of course, is the feeling of your mother-in-law.
All right. Right off the bat, let's get rid of the mother-in-law part of the equation. Give her the respect of listening to our advice. Nod your head a couple of times, OK, OK and move on. If she keeps it up, I would politely tell her that she had her chance.
The fact she had six chances to raise kids, and now it's your turn.
OK. These are your kids to raise. She had her chance. Now it's your turn. This is a decision, Cecilla, that's between you and dad and your doctor, who by the way sees many more kids in a single morning than your mother-in-law raised and who is much better qualified to give you guidance on the matter.
So what's my take on the subject? Which is what you want to know, even though [Laughter] the mother-in-law part of the question got a little more interesting.
I think your child might have the beginning of ADHD. And then again, he might not. [Laughter] How's that for a response.
But that's the truth and it's the right response. If you take a large group of rowdy three- and four-year olds, while they may all look similar at first glance, which you're going to find is this. That some of them do have the beginnings of ADHD.
Some of them are simply bored out of their minds. Some of them have behavioral problems brought on by poor parenting and most of them probably have a combination of two or more of those things.
So each of these conditions are addressed in a different way and there's some easy things you can do to sort out what's going on and deal with them. Simple ADHD involves easy distractibility and impulse control issues.
OK, what three- or four-year-old doesn't fit that description? Not very many. So do all three- or four-year-olds have ADHD? Of course not.
Will a large number of these kids go on to have ADHD when they become school age? Yes. Will a large number mature and settle down and do finance school? Yes.
So rowdiness during the toddler years is not necessarily a good predictor of future ADHD. It is a little bit but it's not. If you got a rowdy toddler, they're going to have ADHD. You can't say that.
On the other hand, family history is a great predictor. So, Cecilla, this does not necessarily bode well for your son, not because he's a rowdy three- going on four-year-old but because there's so many relatives with ADHD, if indeed those relatives had the correct diagnosis.
So what do you do now? It depends. You want to make sure that he's getting really good stimulation that uses his mind – puzzles, building blocks, tinker toys, link and logs – and you got to get down and play with him and make him use his noggin.
Put things together and when he's getting out of control, redirect him, get down on your hands and knees and play with him because boredom leads to bad behavior. So you want to make sure he's not bored.
Now does this take a lot of time and energy and work on your part as a parent or grandparent or a babysitter? Yes, it does. But someone has to do it and medicine is not a good substitute.
Next, is this an impulse control behavioral issue? How well does your son follow rules? How well does he follow instructions?
Does he stop unwanted behavior when you tell him to stop?
Medicine generally does not help kids follow rules and obey those in charge for that. You need super nanny. I mean, not you don't literally need to call the show or you can get her book, but you just got to use the super nanny principles.
Kids need to know what the rules of the house are. For some rules there need to be immediate consequences and the consequences must be predictable, consistent, happen every single time.
For other rules, reminders are appropriate. So if your child breaks the rule, you remind them of the rule and ask them to stop. If they don't stop after your point out the rule, then again there need to be consequences and the consequences have to be predictable and consistent and happen every time.
That means no exception. That means the consequence occurs every time they break the rule or every time they refuse to stop breaking the rule once you point out the fact that they are breaking it.
They may have a five-minute timeout 50 times a day.
This drives you crazy. Fifty times a day! My kid's in a five-minute timeout. But you know what? Next week, it will be 45 times a day and the week after that, 40 times a day. And the week after that, 20 times a day.
It takes time. It takes patience, but it works. So you got to make sure that you have good parenting skills. That your kids understand what kind of behaviors expected of him.
They understand what's going to happen to them if they break those rules and you aren't consistent in making those consequences happen.
Now once you've eliminated boredom and once you have stuck to a well-designed behavioral modification plan, and you're using rules and rewards and timeouts, at that point, if your three- or four-year old is still having trouble, then and only then, I might consider medication especially with a strong family history.
I'd be quicker to do with the four-year-old than with than with the three-year-old. But I will say this.
The vast, vast, vast majority of rowdy three- and your four-year-olds can be managed by getting down on your knees and playing with them, eliminating boredom, making them use their minds, helping them to understand what rules are all about.
And those things will go a long way to helping your child even if they are destined to have ADHD issues later on during the school years.
There are a small number of kids who won't respond to these measures, for one reason or another, usually not because of pure ADHD but because of a complex mixture of brain chemistry and environmental/social issues, poor parenting.
And these kids' quality of life and their parents' quality of life can be improved with the use of medication. But that's a decision – that's like a last straw decision that's made between moms and dads and their doctor.
They need to be the ones to make it, and at least in my opinion, mother-in-laws should stay out of it. They had their chance.
All right, moving on to your thumb question, I have to say, I've never seen a kid with two thumbs. So after 10 plus years of practicing pediatrics in busy settings, I can honestly say, I haven't seen it. So I'm not sure how common it can really be.
Now I have seen some reports on the Internet that 1 in 200,000 babies are born with two thumbs and I think that's a bit high. I think what it is, is their definition of what really constitutes a second thumb isn't what you and I have in mind.
It's probably a little nub of skin with some cartilage in it that's next to the thumb. Would you call that an extra thumb? I mean, when I hear extra thumb, I'm thinking, OK, there's six fingers and two of them are thumbs, like in the Princess Bride, the six-fingered man.
That's what I'm thinking. So I think that really what you're saying is that there is a sixth appendage and it's probably a small and not really a full-fledged thumb.
To me, two thumbs mean you don't know which one to take off. So if it's obvious which one should be removed then it's probably not a real thumb.
The one you clearly need to leave to behind, that's the child's thumb. So what would I do? Me, personally, I'd have it removed. No question.
And is my decision to do that medical or social? I guess it depends on function. If the extra appendage seems like would interfere with normal hand function then it's a medical issue.
If it's not going to interfere with normal hand function, then it's a cosmetic issue, so then I guess it's more of a social problem rather than a medical problem.
But for me, personally, either way, whether it's cosmetic or functional, I'd have it removed. The question is, when? When do you have it removed? Because you do have to factor and the risk of surgical and anesthesia complications.
If it's going to be a functional problem, I think you'd want it done as soon as possible because then the benefit of doing it outweigh the risk of surgery and anesthesia which are small risks.
If it's purely cosmetic, you have some more time to play with. You might want to get the little baby a little older so that you diminish even more the risk of surgery and anesthesia.
But again, the decision on what to do and when to do, it is a collaboration between mom, dad and the baby's doctor. Notice I didn't include the mother-in-law in the decision-making tree.
OK. Let's move on to our final question. This one comes from Jennifer in Cabot, Arkansas.
Jennifer says, "I ran across this article today. Do you think you can comment on the show? I know it's from 2004, but I'm curious as to what you have to say about Motrin. Thanks. And look forward to hearing your comments. Jennifer"
Even though the article, Jennifer, is from 2004, the case went to trial and the trial was this year. It was in June or July. I think it was June of 2008 so is still is timely.
So let's start with the article itself because it's interesting on many levels. And I'll have link in the Show Notes at pediacast.org to this particular article. But let's go ahead and go through it.
This is dated December 29, 2004. Sabrina Johnson, age seven, filed suit today against Johnson & Johnson in the Los Angeles Superior Court/Compton Division claiming that an allergic reaction to taking Children's Motrin caused her to become blind and photosensitive.
Her complaint for damages alleges strict product liability, negligence, breach of express and implied warranties, and deceit by concealment. And in typical lawyer fashion, McNeil Pharmaceuticals, McKesson Corporation, SAV-ON Drugs, Cardinal Health, and Ralphs Grocery Company were also named as defendants.
Miss Johnson alleges that Johnson & Johnson and the other Defendants' failure to warn the public or educate the medical community about the possible risk of Stevens-Johnson Syndrome with using Children's Motrin makes it an unsafe product and dangerous to sell to consumers.
Since the late 1980's, the Plaintiff contends that the Defendants knew about the connection between Children's Motrin and these severe, potentially fatal reactions. Miss Johnson also alleges the Defendants knew from their own clinical trials of Children's Motrin that it caused cases of Stevens-Johnson Syndrome.
Miss Johnson alleges the Defendants were put on notice of the high risk of consumers and users of Children's Motrin after the completion of a major clinical trial known as the Boston Fever Study, which was the basis of the FDA's approval of the over-the-counter sale of the drug.
She contends the Defendants knew there were cases of Stevens-Johnson Syndrome in the clinical trials but did not report them and misrepresented the true incidence of serious reactions associated with the drug during the Boston Fever Study.
On September 8, 2003, Sabrina Johnson and age six, came home from school complaining of a fever. Her parents gave her Children's Motrin in accordance with the materials and instructions included with the drug that afternoon and again in the evening.
On the morning of September 9, 2003, Sabrina still did not feel well and was taken to see her doctor. After being examined by her pediatrician, she was hospitalized and isolated in the Pediatric Intensive Care Unit at Cedars-Sinai Medical Center in Los Angeles, California, with a high fever, redness in the eyes, a sore throat and a rash covering her back, trunk and other parts of her body.
On September 10th, 2003, Sabrina's eyes could only be forcibly opened by an ophthalmologist, causing her unbearable, excruciating pain. By November 2003, Sabrina was completely blind.
It was later discovered that she had suffered a severe adverse reaction known as Stevens-Johnson Syndrome as a result of ingesting Children's Motrin.
Sabrina continued to have ongoing medical problems as a consequence, including photosensitivity. She is unable to independently open her eyes and she has had nearly 20 eye surgeries in a continued effort to restore her vision.
"In the name of children everywhere, our family wants Children's Motrin taken off the market until it carries a warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms," said Sabrina's mother, Joan.
"Had there been appropriate warnings on the Children's Motrin that we gave Sabrina, we would have known what to look for and would have known to stop giving her the drug and call a doctor. Johnson & Johnson and other Defendants never gave us that opportunity and our precious little girl now lives literally and figuratively in the dark."
"Johnson & Johnson made a reckless, callous decision when it decided not to tell the public that Stevens-Johnson Syndrome is one of the adverse side-effects of taking Children's Motrin," said Sabrina's father, Kenneth.
"The pharmaceutical industry owes a duty to consumers to warn them of any and all potential risks in taking their drug, whether they are prescription or over the counter. Not a day goes by that Joan and I don't say to ourselves, 'If we had only known, if we had only known'. We hope that this lawsuit will put an end to their indifference."
"This lawsuit is the only warning label the public is going to get until Johnson & Johnson re-labels Children's Motrin," stated Atty. Brown Greene, "so that it carries a warning about the dangers of Stevens-Johnson Syndrome.
"We hope families around the world will take heed and toss out any Children's Motrin in their medicine cabinets and demand stores pull it off their shelves. The alleged benefits of Children's Motrin do not outweigh exposing any child to Stevens-Johnson Syndrome and its dire consequences. Better safe than sorry."
"The fact that even one child might react adversely to Children's Motrin is enough reason to require the makers of Children's Motrin to provide full disclosure to consumers and their doctors about the risks of Stevens-Johnson Syndrome," said Atty. Geoffrey Wells.
"Just ask Sabrina Johnson and her parents. We intend to marshal all of our resources to make sure that she has her day in court."
OK. And by the way, the case was tried as I said this year and it ended with a jury verdict and yes that was it.
The trial's June/July because the jury verdict came out July 17th, 2008. And the jury said, "The absence of information about Stevens-Johnson Syndrome on the warning label of Children's Motrin was not a contributing factor in the injury of the child. And of course the family's lawyers planned to appeal.
OK. So let's talk about all this. First of all, what is Stevens-Johnson Syndrome? I'm going to simplify this a bit. It's a skin condition that was first described by Dr. Albert Mason Stevens and Dr. Frank Chambliss Johnson, so Stevens-Johnson Syndrome, in 1922.
And it's an example of the immune system "running amok". And what happens, and again to be simplistic is that an antibody-antigen complex. So what is that mean?
There is something in the body that your body does not like and your immune system attacks it with an antibody. So now you have an antigen, which is that substance the body doesn't like, and attach to it is an antibody.
Instead of the body processing this antibody-antigen complex in the normal way, the complex – so this antigen attached to an antibody – gets deposited in the skin and mucous membranes.
And their presence there causes an intense reaction by the immune system now against that complex. And it's even a bigger reaction and it causes cell death at the level where the epidermis, which is the outer layer of skin, attaches to the dermis, which is the deeper of skin.
So that transition zone between zone between the epidermis and the dermis, the cells die and the outer layer of skin falls off or sloughs off.
And of course that's a very bad thing, especially if large portions of skin and mucous membrane are involved. It results in fluid loss. It results in invasion by microorganisms and possible bacteremia – bacteria in the blood – and then sepsis, which can cause death.
And of course, it's going to cause skin scarring. And if it's around the eyes, it can cause blindness, as we found out from Sabrina. It can cause scarring around the eyes so it's difficult to open the eyes.
The sepsis can lead to low blood sugar that can lead to organ failure, which can lead to shock. What the mortality rate of it? That's relatively high. If a 10% of the skin surface is affected, there's about a 5% mortality rate but that mortality rate rapidly increases as the percentage of affected skin increases.
So it's definitely a bad, bad thing. So basically, if Motrin is doing it, the body says, "Hey, Motrin shouldn't be here….
It attacks the Motrin with an antibody and that Motrin-antibody attached thing gets deposited in the skin. The immune system says, "Hey, this isn't supposed to be here… and launches a big inflammatory reaction, causes cell death and then the outer layer of skin gets disconnected from the deeper layer of skin and falls off.
So the next question becomes, OK, what things can do this? I mean what things can result in an antigen-antibody complex that the body deposits into the skin. The first group are infections and a lot of them are viruses.
Herpes simplex virus can do it; influenza virus; mumps virus; the bacteria that causes cat scratch fever can do it; histoplasmosis can do it; Epstein-Barr virus can do it; and there's others.
And then the drugs can that can do it – Fluconazole, which is an anti-yeast medicine; the penicillins;
The sulfa antibiotics are probably the biggest doers of this. Zithromax has been known to do it. Some anti-seizure medications can do it and of course, ibuprofen or Motrin or Advil can do it.
Also malignancies can do it. So cancer cells can do it. Carcinomas, lymphomas and then there are ones that we just say idiopathic or we don't know what the antigen was. They weren't on any drugs. They don't have any malignancies. There's no evidence of any recent infections and they still get Stevens-Johnson Syndrome.
Now the next question becomes, OK, this sounds like a terrible, terrible thing. How common is it? I mean how often does this happen? In the United States, Stevens-Johnson Syndrome affects 1 in 1 million persons each year so that's about 300 cases a year in the entire United States.
And those 300 cases aren't all caused by Motrin.
Motrin is just one little slice of those 300 cases. Now should a warning be on the label? Those are the facts. It's extremely rare but it is extremely serious, and ibuprofen is a known risk factor.
So does a pharmaceutical company have the responsibility of putting every possible risk on the label? Does a doctor or a pharmacist or a grocery store that houses the pharmacy or the wholesale distributor of the drug – do any of these people have the responsibility to warn us about every single possibility, even the really, really rare ones?
I don't have an answer for that. I mean it's tough. As a consumer, I want to be well informed. But you start throwing too much information at me and I start to lose sight of the question that was in my head because of all the details.
So in this case, would the label have made a difference? If there had been a warning on the label about the possibility of Stevens-Johnson Syndrome, which can make your skin fall off, would that have made a difference for little Sabrina?
The parents say it would. The jury says it wouldn't, which is right. Your guess is as good as mine. I mean my heart wants to believe that it would have made a difference but my head tells me otherwise.
That parents probably only looked at the dosing chart anyway and would never have ever seen that warning. But I can't say for sure.
And finally the biggest question of all, should you use Children's Motrin for your own kids or should you throw it away like Sabrina's parents asked you to do? And would I use it for my kids?
You have to decide for yourself. But for me, it comes down to risk-benefit analysis, which we've talked about before. Now Sabrina, one of her parents said, it's – or maybe it was the lawyer. I can't remember now.
But someone involved in this case said that the risk of Stevens-Johnson Syndrome does not justify any benefit that you get from Motrin. I wonder then are they putting Sabrina in a car?
Because there's risk that semi-truck is going to cross the median and hit them head-on.
Do they let Sabrina cross the street? Sure they're there but what if someone zooms around the corner and I mean, the parents are there with her.
There's risk in life. One in a million chance, I mean, one in a million chance, the odds of being struck by lightning in a given year are 1 in700,000. So you have a better chance of being struck by lightning than getting Stevens-Johnson Syndrome from any cause, not just Motrin but all the things in the world can cause it.
Your chance of getting hit by lightning is more than your chance of getting Stevens-Johnson Syndrome. So I mean, I feel terrible for this little girl who's now blind and had to go through this.
And my heart tells me that 'something must be done here'. But on the other hand, when you look at it from a practical public health kind of standpoint, these things happen and we can't control who happens to and when it happens.
But you start putting every warning on there and you're going to have a four-page thing with tiny little print. No one's going to read that, anyway. So for me, as I said, it comes down to risk-benefit analysis.
Does the benefit of Motrin – fever reduction, pain control – outweigh the risk of the problem, in this case, Stevens-Johnson Syndrome?
And in my mind, if my child has a high fever and they're miserable because of it, or if my child's in pain and I know Motrin will relieve that pain better than Tylenol, then I think the benefit outweighs the risk because you're looking at 1 in a million chance of having the complication. That's pretty good odds.
Again, you got more chance of being hit by lightning. So I feel my odds on this are pretty good.
Now, Sabrina's parents are going to agree with that because of what they've gone through and I can understand that.
And a thing is too that if I do it and if I give it and my child is that 1 in a million case, can I live with it? I guess that's the real question you have to ask yourself.
Are you willing to take the chance? If you say yes, it's worth it. And it happens. Can you live with the fact that you gave it? Well, if I was giving Motrin to prevent a fever, not to treat a fever, but I was giving Motrin to prevent a fever, or if I was just giving it because my child was being overly dramatic, and I said 'here just take this. It will make you better' and then because they took something the child will stop complaining.
If I did that and something happened that would be tough because I didn't really have a good reason to give it. But if my child really needed relief and I was trying to help, Tylenol wasn't working for pain or fever.
And so I really had the reason to do it, I knew the risk but it was a tiny one then I think I could live with it better than if they really didn't need the drug to begin with.
I mean we buckle our kids in the car, right? But it's still not a guarantee it will save their life in a crash. We put helmet on their heads but the helmets don't make their head destruction proof. We remind him to stop and look both ways before crossing the street. We tell him not to talk to strangers.
We teach him to make many more smart decisions that can have life or death implications. But at the end of the day, we don't wrap him in bubble wrap. We don't forbid him to ever ride in the car. We don't take their bikes away from them. Why? Because we have to live our lives.
And the chance that cars and bicycles and Motrin are going to improve our lives when used correctly surpasses the danger of those things many times over.
So that's my take. I'd still use Motrin myself. I'd still give Motrin or Advil to my kids but only when they really need it. So I hope that helps, Jennifer.
We're going to ahead and take one final break and we will back and we'll wrap up the show, right after this.
All right. Thanks to all of you for your patience and your support and all the questions and comments that I've gotten over the last couple of months. We have made our move. We are in Florida, no longer in Ohio, coming to you from Summerland Studio, not Birdhouse Studio anymore.
Summerland Studio and quite happy to be here. New job is going great. The folks there, I have to give them a shout out at After Hours Pediatrics because they really are nice company to work for, a nice group of people to work with, and nice group of patients to take care of.
So thanks go out to all of you as well.
Thanks to Vlad at Vladstudio.com for providing the artwork, both at the website and on the feed. Thanks for my family for letting me put this together and it's more of future things because I really haven't been working on that much the last couple of months.
But it's going to get busy again as we go to the weekly format. So I'm going to say thanks in advance because it's going to take some time out of our family life. That's OK. The kids are doing school. Who also I want to thank?
Oh, of course, Nationwide Children's Hospital for providing the bandwidth, also all of our other sponsors who make this show possible.
Also I'll remind you that my wife and my daughter both have blogs that are usually somewhat humorous.
They tried to be happy. They usually are. So you might want to check them out. They also went sort of a hiatus with the move but they're back in business.
The Pediascribe blog, which my wife does, the post I'm highlighting this week "Is This Vacuum Sucks?" [Laughter] OK. Her vacuum sucks. So you want to check that out. We'll have a link in the Show Notes for you at Pediacast.org.
And my daughter, my teenage daughter wrote "Our House Is Built On A Burial Ground". So you want to check that out. Her blog is Baggachips, baggachips.com. You can also get there by going to Pediacast.org, click on the link in the Show Notes.
Also, I'd like to remind you that the PediaCast shop is open. We have t-shirts. We also have duffel bags, sort of tote bags. That's what I'm trying to say. Hey, great for grocery shopping, very green way to go.
And you can get the word out about PediaCast while you're at the grocery store.
We also have a poster page at the website where you can download PDF files, print them out, hang them up on bulletin boards all over the place, telephone poles, you name it. Don't make your neighborhood tacky, though.
We have a Listener Survey that is very important, just helps with demographics. It's in the side bar at pediacast.org. Just to ask you some quick questions. We can get an idea who our listeners are, and it will not take long. I mean it's like a 30-second kind of survey.
So while you're there, we also have some surveys up for some our sponsors in the Show Notes. You want to check that out as well.
OK. I think we've covered just about everything. We will see you next Wednesday. Oh, I didn't mention that.
For right now, I'm going to try Wednesday releases of the shows. I don't get any money in Tuesday to work on them and then a few days off. So Wednesday, it used to be Monday. We're going to a Wednesday release date for now. We'll see how it works out.
So I will see you next Wednesday and until then, this is Dr. Mike saying stay safe, "Stay healthy and stay involved with your kids….
So long everybody!