The Food and Drug Administration (FDA) has rigorous standards for approving new medications to be used in the United States. Medications have to go through a multi-step process, during which the safety and effectiveness of the medication has to be proven. Of course, this mechanism is in place to protect the consumer (patient) and has had several notable successes, such as preventing thalidomide (a medication used to prevent nausea during pregnancy, unfortunately causing severe limb defects in some children) from reaching the American consumer.

Some older medications pre-date the FDA process, even though this process has been in place for many decades. Included among these older medications are some of the pharmaceuticals used in the decongestant and cough therapies used by adults and children. Thus, these medications have never been scientifically proven to be effective and additionally, concerns regarding safety, especially in young children, are present. For example, the decongestants can cause disturbances in the rhythm of the heart, potentially a high price to pay to unclog your child's nose!

For these reasons, the FDA has recommended that these medications not be used in children.

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