The U.S. Food and Drug Administration should take the advice of its own panel of experts and immediately insist that cold and cough remedies for children be taken off store shelves.
That’s the advice from an editorial in this week’s edition of the influential New England Journal of Medicine.
The piece, released Thursday, says the FDA “should immediately ask companies to remove these products from store shelves and begin legal proceedings to require them to do so.”The editorial is written by Dr. Joshua Sharfstein, the commissioner of health for Baltimore; Marisa North, a medical student at the Johns Hopkins School of Medicine in Baltimore; and Dr. Janet Serwint, a professor of pediatrics at Johns Hopkins.
In their appeal for action, the writers cite recent data from the Centers for Disease Control and Prevention, which says more than 1,500 children under the age of two were sent to emergency rooms in 2004 and 2005 after taking cold medications.
They also note that the FDA expert panel that met in October tied the deaths of 123 children under the age of six to the drugs.
The editorial casts doubts on the effectiveness of kids’ cough and cold medications, saying that recent studies on the use of the products in kids under 12 years of age “have not shown any meaningful differences between the active drugs and the placebo.”
The authors say they want the FDA to do three things:
- issue a public statement explaining that the products have not been shown to be safe and effective for children under six;
- take action against misleading marketing; and
- revise its monograph accordingly.
Despite the recommendation from the FDA panel of experts that the products no longer be given to children under six, manufacturers have refused to stop their marketing, the authors note.
“The products and their ‘toddler’ formulations are still being widely advertised to parents in ways that suggest that they are known to be safe, effective, and recommended by most pediatricians,” the authors note as they called for the agency to take action.
“Although the FDA does not need to follow the recommendations of its advisory committees, we believe that it should immediately ask companies to remove these products from store shelves.”
About a week before the FDA panel met, the manufacturers of a number of infant cough and cold medicines designed for children under two years old voluntarily pulled the products from shelves.
At the same time, Health Canada issued an advisory about giving the medications to young children and promised to review the labelling of the products.
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