Cough And Cold Medicines For Children Under US Panels’ Revision
By John Wolper
16:37, October 19th 2007
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Cough And Cold Medicines For Children Under US Panels’ Revision

FDA will receive this Friday a recommendation from a committee of outside experts if cough and cold medicines should still be sold for children up to age 12.

A week ago, major manufacturers like Wyeth, Prestige Brands, Johnson & Johnson and Novartis decided to withdraw their cough and cold products for infants. Linda A. Suydam, president of trade association, said the reason for this voluntary withdrawal is safety. She added that “there have been rare patterns of misuse leading to overdose recently identified, particularly in infants”.

Three weeks ago, the Consumer Healthcare Products Association and safety reviewers within the Food and Drug Administration recommended not using the products on infants and even proposed a market ban of over-the-counter cough and cold products for children under 6.

Cough and cold medication for infants was approved a long time ago on the assumption that children were just small adults and drugs that were tested on adults should work on children too.

Dr. Joshua Sharfstein, health commissioner for the city of Baltimore, referring to cough and cold products for children, said: "FDA has permitted widespread marketing that is not supported by scientific evidence".

New studies show that these drugs actually have no effect on children or, even worse, they could even hurt them.

Sharfstein and other physicians are asking the government to restrict selling these drugs for kids up to age 6.

Drug makers say that problems after using the medicines followed an accidental overdose. "Some parents and caregivers need better information on how to use these medicines appropriately", said Linda Suydam.

95 million cough and cold products for children are sold every year.

The FDA usual follows the advisory panels’ recommendations. And today, the FDA’s advisory panels on nonprescription and pediatric drugs will hear from doctors, drug makers and FDA staff on the safety and effectiveness of cold and cough medicines for children. They will also debate and decide on recommendations that may include banning marketing, adding label warnings or requiring studies in children.



© 2007 - 2008 - eFluxMedia
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