Child Deaths Lead to FDA Hearing on Cold & Cough Meds
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Updated: 2:39 PM Oct 18, 2007
Child Deaths Lead to FDA Hearing on Cold & Cough Meds
The Food and Drug Administration is holding a hearing on Oct. 18 after a voluntary recall was announced last week of more than a dozen types of infant cough and cold medicine.
Posted: 2:39 PM Oct 18, 2007
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The Food and Drug Administration is holding a hearing on Oct. 18 after a voluntary recall was announced last week of more than a dozen types of infant cough and cold medicine.

From Dimetapp to Pediacare to Robitussin--these are the 14 brands of over-the counter infant cough and cold medicine that have been voluntarily recalled by their makers.

At an FDA hearing aimed at finding out if these medicines are safe for children under six, a health official criticizes the agency itself and the manufacturers.

"The FDA did not approve these products based on the basis of evidence of safety and effectiveness in children," explained Dr. Joshua Sharfstein, with the Baltimore Health Commission.

But the manufacturers say the medicine is safe and insist the recall was announced out of a quote, "abundance of caution."

They say cases of children who died after taking the medicine were often the result of misuse or an overdose.

In the case of four-month-old Devon Mehlberg-Alvarez, doctors say he died because his body couldn't metabolize a key ingredient found in many cold and cough medicines.

"He was just beautiful and I miss him so much, and I loved him so much," admitted his mother, Dimitria Alvarez.

Hoping to help parents dispense medicine correctly, manufacturers are warning that infants under the age of two are the most vulnerable to misuses of the products.

Parents must read the labels carefully and use the medicine as directed, and store the medicine safely away from the reach of children.

But some say these warnings are not enough.

Some experts testifying say these children should not even take these medicines at all.

They argue that the medicine was never tested on children and the makers only used data from adult studies.


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