FDA Warns Children's Cough Medicine Is False Friend
By Anna Boyd
16:39, August 17th 2007
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FDA Warns Children's Cough Medicine Is False Friend

The Food and Drug Administration issued a warning this week, advising parents to be careful about giving their children cough and cold medicines.

Cough and cold drugs are usually nicely packaged, seem safe to give to children and generally prove to be efficient. What parents may not know though is that these products are not meant for treatment of children’s cold-related problems.

The FDA issued a Public Health Advisory Wednesday, urging parents not to give such medicines to children under the age of 2, unless they have consulted a doctor.

Among the serious adverse affects are neurological problems, increased blood pressure, hallucinations and even death. Some products packages show babies in diapers, misleading customers.

The agency also announced a meeting of its Nonprescription Drugs Advisory Committee on Oct. 18, according to the New York Times, to discuss whether further measures need to be taken, such as warnings or even limitation of some drugs’ availability.

The agency said that even though there are warning labels on the drugs, advising parents to consult a doctor before administering them to their children, many fail to follow the advice.

One possible solution to this situation would be to restrict the drugs’ availability.

Another issue at hand is the need to reassess some children’s medicines, especially those approved years ago, when the agency’s standards were less strict than they are now. Some children’s drugs were only tested on adults, the New York Times reports, and it was then assumed they were safe and efficient for children as well.

The situation has been building up for some time now. The Centers for Disease Prevention and Control conducted a study in January this year, which showed that during 2004 and 2005, over 1,500 children under the age of 2 needed emergency visits to the hospital due to inappropriate administration of cold medicines.

Three of the children died.

There are health experts saying that the problem goes beyond children under the age of 2 and that the warning should extend to children under the age of 6.

The drug manufacturers have replied to this by insisting that their products are safe and have been deemed so by the FDA.

A statement issued Thursday by Linda Suydam, president of the trade association Consumer Healthcare Products Association (CHPA) said:

“Millions of Americans safely and effectively use OTC cough and cold medicines every year, both for themselves and for their families. These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medications families have trusted for decades to help relieve cough and cold symptoms and make their children feel better.”



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