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Parents May Not Be Aware of FDA Guidelines for Treating Children With Diarrhea

[ 09/09/2005 ]
Parents May Not Be Aware of FDA Guidelines for Treating Children With Diarrhea
Many parents recognize diarrhea as a common childhood illness that occurs, on average, once or twice a year. However, according to the results of a recent survey, an alarming 80 percent of parents do not know there is only one brand of over-the-counter (OTC) anti-diarrheal medication approved for use in children 6 to 11 years of age.

"Safety is always a top concern for parents when medicating their children," says Dr. Tayna Remer Altmann, pediatrician and clinical instructor at the University of California at Los Angeles (UCLA). "However, parents may not be aware that loperamide HCl, the active ingredient in Imodium A-D for children, is the only FDA-approved ingredient indicated for relief of diarrhea in children. It is important for parents to be familiar with this information so that they can properly treat their children without putting them at risk for potentially serious side effects from the wrong medication."

In April 2004, the U.S. Food and Drug Administration (FDA) mandated that anti-diarrheal brands containing bismuth subsalicylate could not be labeled for use among children under the age of 12. The mandate was based on the fact that these brands contain salicylates, from which aspirin is derived, and may put children under the age of 12 at risk for Reye's syndrome, a disease that can adversely affect all the organs of a child's body. Even though 68 percent of parents who were polled in the survey, which was commissioned by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC Inc., are aware that aspirin products should not be given to children under the age of 12, 42 percent were unaware that any OTC anti-diarrheal products contain aspirin.

While the FDA's ruling led to several label changes among OTC anti-diarrheal medications, Imodium A-D for children was not affected because it does not contain bismuth subsalicylate. Therefore, Imodium A-D is the only FDA-approved, OTC anti-diarrheal brand for children between the ages of 6 to 11.

Parents and guardians can learn more about childhood diarrhea and the ways to treat their child's symptoms by visiting an interactive and educational web site - http://www.talltoilettales.com/ - which provides information about the causes, symptoms and treatments of diarrhea in children ages 6 to 11.

About Imodium A-D for Children

Imodium A-D, the only OTC anti-diarrheal brand approved for children ages 6 to 11, controls diarrhea symptoms by helping children's bodies absorb water and nutrients, which prevents food and fluids from moving through the colon too quickly. Imodium A-D for children is available in an easy-to-swallow, mint-flavored liquid form. The active ingredient is 1 mg of loperamide HCl/7.5mL. It contains the only ingredient indicated for the treatment of acute diarrhea in children 6 to 11 years old.

About McNeil Consumer & Specialty Pharmaceuticals

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., markets prescription and over-the-counter (OTC) pharmaceutical products. The company's OTC products include complete lines of TYLENOL(R) acetaminophen, which celebrates 50 years of trust and innovation in 2005, and MOTRIN(R) IB ibuprofen for adults and children. Prescription products include CONCERTA(R) (methylphenidate HCl extended-release tablets) and FLEXERIL(R) (cyclobenzaprine HCl 5 mg tablets). Other McNeil brands include IMODIUM(R) A-D anti-diarrheal, ST. JOSEPH(R) 81 mg Adult Aspirin and NIZORAL(R) A-D Shampoo.

Methodology

Harris Interactive(R) fielded the online survey on behalf of McNeil Consumer and Specialty Pharmaceuticals between June 28 and 30, 2005 among a nationwide sample of 2,365 U.S. adults aged 18 and older, of whom 266 are the parent or legal guardian of a child between the ages of 6 and 11 who lives in their household. The data were weighted to be representative of the total U.S. adult population on the basis of region, age within gender, education, household income, race/ethnicity and propensity to be online. Though this online sample is not a probability sample, in theory, with probability samples of this size, one can say with 95 percent certainty that the overall results have a sampling error of plus or minus 3 percentage points. Sampling error for the results of those who are a parent or legal guardian of a child between the ages of 6-11 who lives in their household is plus or minus 9 percentage points.

Source:
PR NewsWire
www.prnewswire.com/
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