Claim: A single dose of Children's Motrin can cause ulcers and gastrointestinal bleeding in children.
Example:[Collected via e-mail, 2003]
I know most of you don't know each other on this email, but you are all friends of mine. I wanted you all to know this, because my friends didn't have your email addresses to keep you up to date when it happened, but I think because you are all Mommy's and Auntie's it is important for you to know. (Let me start by saying Ally is fine now, I don't want to scare you as you read this).
Last Monday morning began like any other with Ally getting up and asking for some OJ. She had been tested for Strep Throat over the weekend because she complained of some cold symptoms and was running a fever.
We were going to get the Strep test results back Monday morning. The only thing we did for the cold over the weekend was to give her one single dose of Children's Motrin, which she has taken since she was 15 months old, and some cough medicine.
She was pale and lethargic over the weekend, and I attributed that to the cold. So I poured her some juice and I continue to make Scott's lunch. I hear a noise and I turn around and blood is just pouring out of her mouth onto the kitchen floor. Sort of like throwing up, but not really and it just keeps coming.
It is dark with clots in it, similar to a period. She is otherwise fine and just scared. I mopped up the blood and put some of the paper towels in a baggie to bring to the hospital for them to test. At this point, I am sure it must be cough medicine or something else that is red, it couldn't possibly be blood, which is how I probably kept it together on the way to the hospital.
To make a long story short. I took her to Winchester Hospital and she is there for 3 hours. She was transported by ambulance to Children's and it was when she got there that things started not to look great. Her red blood cell count was dropping and her heart was racing, indicating there was still internal bleeding going on. They wanted to do a scope of her intestinal region to find out the cause of the bleeding, but could not do one until she stabilized.
She got a transfusion of blood from the blood bank and they replaced 50% of her red blood cells. She did not stabilize until Tuesday morning. I remember thinking maybe if I just fell asleep for an hour, when I looked at the monitor maybe her heart rate would go down and she would stabilize. Late Tuesday afternoon they brought her into surgery and did an endoscopic procedure down her throat to access what was going on. They warned us if she started to bleed, they would probably need to go right into surgery. It was there they found four ulcers (3 in the base of her stomach, one in her small intestines).
The great news is they had stopped bleeding and would hopefully completely heal. She was discharged on Wednesday and is doing really well. She has issues with needles and people in scrubs (they actually needed to sedate her in the hospital just to draw blood).
We will receive pathology reports this week (they did a biopsy with the endoscope) to rule out Chron's Disease or any other gastrointestinal disorder which would have made this happen. They are 99% sure that the biopsy will come back negative and they told me what the cause of her ulcers were: the one single dose of Motrin.
Here's the scoop. It seems that our pediatricians and magazines that inform us of all this great stuff seemed to leave out the near fatal effect Motrin can have on some children. It isn't even listed on the back
of the box.
I began using Motrin when Ally was 15 months old — she had a virus and had a 104 degree temp so we took her to the ER, where they suggested and gave her Motrin. They said some children just do better with Motrin than Tylenol. It doesn't have to be a lot of it, it doesn't happen over a period of time, it could just be one dose on the wrong day, maybe when the child hasn't really been eating a lot.
The GI Specialists at Children's Hospital seem to all know about it, and I am angry that I didn't.
I do think I heard that it could more easily cause stomach irritation. We looked through the Physician's Reference book at Boston Medical Center and it said that only clinical studies have been done on adults for this and then some gastrointestinal bleeding has occurred - nothing about effects on children.
What is also bad is that Winchester wanted to send her home after the three hours. They thought it was an isolated incident and her vitals were good. I told them she didn't look right to me and I wanted a second opinion. It wasn't until she got to Children's that her vital signs began to go crazy and that they decided she needed a transfusion rather quickly. (Lesson #2, always trust that maternal instinct).
Five years ago I would have been worried that I would have hurt the doctors feelings asking for a second opinion, but not now. Ally is good, just tired and is on medication for three months. I implore you to forward this email to every mom, dad, aunt, uncle or anyone you know who has children. I never want any parent or child to go through what we went through in the past week.
Please remove all Motrin or Advil products for Children from your home and never purchase them again.
I am following up with complaints to the FDA and a letter to Parents magazine about Ally's story. I just want more parents to be aware of this possible side effect. Allison is a perfectly healthy child otherwise, that has probably only thrown up 5 times in her four years on the earth. And I am fine too :-). I am just starting to process it all now, I didn't have much time to do that in the hospital - I never left her bedside.
I crawled into her bed last night long after she was asleep and just cried and cried and cried (she's a heavy sleeper!). I couldn't stop. I just held her, so grateful that I didn't have to contort myself around IV's in both arms and a tube down her nose to hug her like I did last week. I know I will worry about her more now everytime she is pale or lethargic.
They said the internal bleeding was going on for a couple of days and that's really why she was so lethargic and pale.
God bless all of you and your families this holiday. Give all you kiddies and nieces and nephews big hugs and kisses and even though this email is long, please send it to as many people as you think would be interested in reading it.
Origins: Dealing with a sick child is one of the more harrowing situations a parent faces. So what could be worse than discovering that the medication you gave your child to treat one medical
problem not only caused an even worse problem, but created a potentially life-threatening condition? Especially when that medication is a common over-the-counter drug given to thousands of children every day? The text quoted above describes one parent's experience with such an occurrence, attributed to a single dose of Children's Motrin — is it possible?
The active ingredient in Children's Motrin is Ibuprofen, a nonsteroidal anti-inflammatory drug effective in relieving pain and reducing inflammation. (Ibuprofen is also marketed under several other brand names, such as Advil, Medipren, and Nuprin). Children's Motrin Suspension first became available as a prescription product in 1989, and in 1995 it was cleared by the Food And Drug Administration (FDA) for marketing as an over-the-counter product. Both those landmarks occurred only after the product had been extensively tested on children:
Before Children's Motrin became an over-the-counter product, its safety profile was supported by a landmark study involving nearly 84,000 children — one of the largest and most rigorous children's clinical studies ever conducted. The study spanned 3 years and included 1,735 physicians nationwide.
Even after a drug has undergone rigorous pre-approval testing, however, some users of the drug may experience problems that were not uncovered during clinical trials and only became known after the product was released to market. One common type of post-approval problem is allergies — every drug can potentially cause allergic reactions in at least some users, and the best clinical trials can do is ensure that the incidence of allergy is as low as possible and the known reactions not severe enough to pose a significant health risk to those who might be allergic. Also, clinical trials, no matter how extensive the testing and how large the test group, cannot ever absolutely guarantee that a drug will be 100% safe for everyone under all circumstances — the possibility always remains, even though it may be extremely small, that some freakish occurrence or rare combination of circumstances will cause a drug user to experience a seriously adverse
In the case of Ibuprofen, the known severe allergic reactions include hives, facial swelling, asthma (wheezing), and shock, any of which could conceivably be caused by as little as a single dose. Stomach ulcers are also a potential side effect of Ibuprofen, but that reaction was found to occur when large amounts of the medication were taken over long periods of time, not from a single isolated dose. So, what to make of the above account, a mother's experience with a child who supposedly suffered gastrointestinal bleeding prompted by a single dose of Children's Motrin?
It is indeed a real account, written by a Massachusetts woman named Janell in the aftermath of having to take her four-year-old daughter, Ally, to the hospital when the child started coughing up blood and being told by doctors that the source of Ally's gastrointestinal bleeding was four ulcers caused by the single dose of Children's Motrin she had given her daughter earlier that day. As noted, stomach ulcers are a known side effect of Ibuprofen, but generally only in users who take frequent and/or large doses over extended periods of time. Yet Janell told us her daughter had taken Children's Motrin many times before with no adverse effects, that she had given her daughter Motrin only four to six times a year at most, that Ally had taken only a single dose on the day in question, and that doctors had determined from the "shallowness" of Ally's ulcers they had formed quite recently.
The question remains, was Ally's experience a rare freak occurrence, something brought about by an unusual confluence of (as yet undetermined) factors, or a problem significant enough that all parents should be wary of giving Motrin to their children? Johnson & Johnson (the corporate parent of McNeil Consumer Healthcare, which markets Motrin) provided us only the expected boilerplate response:
Reagarding [sic] the e-mail you had received, as the maker of both Pediatric and Adult Motrin® Ibuprofen products, we are interested in all matters relating to these products. For your reference, our Pharmacovigilance/Drug Safety Department is in the process of investigating the e-mail that you had received and is attempting to follow up with Janell, the woman who wrote the e-mail, regarding the health of her child and the circumstances that led to her child's reported experience.
Millions of children have been taking Children's Motrin for several years with no adverse effects, so whatever issue has surfaced here is probably a rare one, but publicized incidents can often bring forth others who have experienced similar problems and lead to the revelation that the issue isn't really as rare are previously believed. Only time will tell whether Janell's experience is indicative of a wider problem with Children's Motrin.
Children's Motrin (U.S. Food and Drug Administration)