Fatalities in Children Under Age 2 When given Cold and Cough Medications

Fatalities in Children Under Age 2 When given Cold and Cough Medications

Fatalities in children under age 2 given cold and cough medications prompted a nationwide recall.

Johnson&Johnson, Wyeth, Navartis or Prestige Brands Holdings recalled over-the-counter medications for infants as reported by the Consumer Healthcare Products Association.

The recall was prompted by a study done by the FDA that showed 54 deaths registered between 1969 and 2004 with the cause being an overdose of cold or cough medication.

The FDA suggested that the over-the-counter cough and cold medicines that contain either decongestants or antihistamines be put under new restrictions including a warning about what is and what is not the recommended for use in very young children.

This included a recommendation that labels contain prominent language describing the risk for overdose in children under age 2 for decongestants and under 6 for antihistamines.

A decision regarding the FDA recommendations was scheduled for October of 2007.

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The overdose can be attributed to the use of more than one product with the same ingredient or multiple doses of the same product. The study included cases dating back to 1969.

There were 54 deaths related to decongestants and 69 related to antihistamines. Most of the cases involved the child being given the wrong dosage.

Most pediatricians express belief that cough and cold preparations are not effective in children under age 2, so the risk in this case is greater than the benefit.

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Doctors recommended that other remedies such as using vaporizers or hydrators, saline nose drops, a rubber nose bulb to suck out mucus, and giving young children plenty of fluids will be effective in keeping them comfortable.

These remedies will ease cold symptoms and not pose the risk to health that the prescriptions were responsible.

A second study was conducted by the Centers for Disease Control (CDC) found that over-the-counter cough and cold remedies were responsible for hundreds of toddlers being injured, and some killed, by overdose of these drugs.

The US Centers for Disease Control and Prevention reported that 1,500 infants under age two suffered from complications from being overdosed on cough and cold medication in the year 2004 and also in 2005.

Overdose may be the result of droppers being difficult to determine proper dosage.

Amazingly the FDA never did a study previously regarding the safety of decongestants and antihistamines in young children but concluded that if over-the-counter preparations were safe and effective for adults, that smaller doses should also be safe for young children to use.

The two studies (the one by the CDC and the other by the FDA) proved the earlier assumption to be wrong.