Personal Injury Law

Should Kids Cold Meds Remain OTC?

By Jane Akre

The Food and Drug Administration (FDA) is meeting with the public today to figure out whether controversial cold medications for youngsters should remain over-the counter (OTC).

Topics discussed will be the age range for dosing, whether tests should be conducted on children, and how they should be designed.

This follows last January's advisory recommending cough and cold meds such as cough suppressants, antihistamines, expectorants, and decongestants, not be used to treat toddlers under the age of 2.

In response, drug makers removed the remedies from store shelves. No official recall was issued or initiated.

Between 1969 and 2006, an FDA review found that 54 children's deaths were associated with decongestant medications made with pseudoephedrine, phenylephrine or ephedrine.

69 deaths were reports associated with diphenhydramine, brompheniramine or chlorpheniramine. Most of the children were under the age of 2. The reports followed a lawsuit by a group of pediatricians who felt the cough and cold meds had never been proven safe.

The Centers for Disease Control and Prevention reports 7,000 American children under the age of 11 are treated in hospital emergency rooms every year because of reactions to cold and cough medications.

Overdosing can occur when parents give two different products with the same active ingredients or give too much of a dose too frequently.

It is considered unethical to test drugs in children.

However, Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, who will testify at the hearings, says that 150 0r so drugs have been tested since the Best Pharmaceuticals for Children Act passed in 2002.

He tells U.S. News that the act gives drug companies an extended marketing time if the drug is found useful in younger age groups.

An estimated ten percent of American kids take cold medications every week.

Most of the time, a cold will go away by itself in about a week. 

Your doctor may recommend taking in plenty of fluids to help loosen mucus and using saline nasal drops.   Occasionally a fever reducer such as acetaminophen or ibuprofen is recommended.  If symptoms do not improve or get worse, contact your doctor. #

Full post as published by InjuryBoard on October 02, 2008 (boomark / email).