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On Oct. 6, 2008, the U.S. Food and Drug Administration (FDA) rejected a proposal by groups such as the American Academy of Pediatrics to ban OTC (over-the-counter) cold and cough medicines for children under six years old. Last year, a panel gathered by the FDA recommended that kids under 6 should not use such medicines because their effects on children have not been studied, and more importantly, the medicines' risks may outweigh their benefits.
The FDA thoroughly evaluated the proposal before forming its conclusion.
Over one-third of all households in the U.S. buy cough/cold medicines, spending about $300 million each year on OTC cold medicines for children. A recent report indicates that at any given time, about 10 percent of the kids in the U.S. are taking cold or cough medicine. However, there is great disagreement among physicians, public health experts, the cold-medicine industry group, and drug companies regarding these drugs' safety for use in children.
The day after the FDA's rejection of the ban, several drug companies took a step toward restricting the use of their products among children — they added advisory wording on the labeling of their cough and cold medicines that warns parents to not give the medicine to children under 4. This is after an earlier advisory stating that the medicines should not be given to kids under 2 years old.
A recent study by the Centers for Disease Control and Prevention (CDC) revealed that about 7,000 children under 11 go to hospital emergency rooms in the U.S. each year after taking cold or cough medicine. About two-thirds of these emergency room visits happened when the child took the medicine without a parent or caregiver nearby — most often among children between the ages of 2 and 5.
(Source: The Washington Post)
If you're concerned about the effects of cough or cold medicine on your child, contact us today to speak with a personal injury attorney who defends individuals harmed by defective drugs.
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