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UPDATE: Drug Manufacturers Voluntarily Recall Cough Medicines for Children Under Two

Lehigh Valley, Pa. (November 21, 2007) – Popular infant cough remedies such as Tylenol Drops Plus Cold, Pediacare Infant Drops Decongestant, Dimetapp, and Triaminic are now being voluntarily recalled because of concerns that these medicines, when used improperly, could cause overdoses in infants under 2 years of age.

An FDA advisory board has also recommended banning any cough and cold remedy for children under the age of 6. The panel found no proof that over-the-counter (OTC) cough and cold medicines were effective at easing symptoms in children younger than 6. However, OTC cough and cold medicine manufacturers are expected to fight the FDA panel recommendations.

FDA Warns Against Giving Cough Medicine to Children Under Two

Getting a cold or a cough is tough enough as an adult, but it can be extremely difficult if your child gets a cold. But before you give your child that dose of over-the-counter cough medicine you may want to reconsider.

The US Food and Drug Administration (FDA) is warning parents not to give children under 2 years of age over-the-counter (OTC) cough medicines. According to the FDA, there have been numerous reports of infant overdoses on OTC cough remedies.

"If you've ever seen the cough medicine aisle at your local pharmacy, you'll see hundreds of different products, and no two products do the same thing," Lehigh Valley Hospital and Health Network pediatrician Amy Vyas, M.D., says. "A lot of products have more than one active ingredient, like a decongestant with a pain reliever. Often and without even knowing it, parents will get two different medicines, thinking that they do different things and then give two doses to their child at the same time, essentially doubling the amount of medicine that should be given. That's how parents can inadvertently cause an overdose."

Vyas also mentions that no child under the age of 2 should ever receive cough medicines under any circumstances. "Even though the label may tell you the recommended dose for a certain age, age has nothing to do with dosage," she says. "Dosage is based on weight, not age. The dose on the label may be for a child of the same age, but not the same weight, and that could cause an inadvertent overdose."

The FDA will hold a panel of medical experts in October to discuss the safety and effectiveness of OTC cough medicines for children. This will help to clear up the issue of safely dosing and the general efficacy of the OTC cough remedies.

Vyas recommends that if your child is sick with a cough that the best thing to do is let it run its course, which could last anywhere between 10-14 days. "Just try to treat the symptoms as they occur, but never give them cough syrup," she says.


This page last updated 2/20/08 03:59 PM
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