A single dose of Children's Motrin can cause ulcers and gastrointestinal bleeding in children.
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 medicalproblem 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 adversereaction.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.Additional information: Children's Motrin (U.S. Food and Drug Administration)
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