11172017Headline:

Philadelphia, Pennsylvania

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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Safety Concerns About Pediatric Cold Medications

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Over-the-counter cough and cold medicines should not be used by children under 4 years old. That is what new labels will say after a recent announcement by manufacturers of pediatric cold medicines. In addition to the manufacturers’ voluntary decision, the FDA plans to reassess the safety of these products. In 2007, FDA safety experts and an advisory panel considered banning the use of over-the-counter cough and cold medicines in children younger than 6 years old. However, initially the manufacturers vowed to fight any restriction except a warning that the products not be used in children under 2. Eight hundred different pediatric cough and cold products are sold in the U.S., with one or more of 39 drugs in each of those products. Yet, multiple studies have shown that these products can be dangerous and that except for sedation, they have no therapeutic effect. Accidental overdose occurs when children get access to the medications, when parents make dosing errors or mix medications. Children under 4 account for most of the injuries. However, some critics believe that given the lack of benefit from the products, children under 6 should not use the products in light of the risks. This recent decision regarding the new labels banning use for children under 4 is one step. It has been a long time coming and should not be the end of review for these products.