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FDA Pushed Drug Makers for New OTC Cold Med. Age Recommendations

Oct 13, 2008 | Parker Waichman LLP The surprise announcement by the makers of children's over-the-counter (OTC) cold medicines that they would no longer recommend that the drugs be given to children under 4 was actually the Food & Drug Administration's (FDA) idea, according to the Associated Press.  Apparently the FDA and manufacturers had been privately discussing such a move since earlier this year.  Once the parties reached an agreement, drug makers publicly announced the "voluntary" move.

While there is little evidence that children's OTC cold medicines are effective, it is becoming apparent that the drugs often put kids in danger.  Earlier this year, the FDA issued a warning advising that over-the-counter cold and cough medicines should not be given to children under two.  The warning came after a 2007 study conducted by the Centers for Disease Control found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines. A second study by FDA safety reviewers reached similar conclusions. Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.

Earlier this month, the FDA held an advisory panel meeting to discuss the issues surrounding children's OTC cold medicines.  At that meeting, pediatricians urged the agency to ban the drugs for children under 6.  The panelists conceded that there was the little evidence the medicine worked, but worried parents would treat their children with adult drugs if pediatric versions were not available.  They did recommend that the drugs not be used in children under six, but said children older than 2 could keep taking the medications while studies investigating their safety and effectiveness were being conducted.

Less than a week after that meeting, on behalf of the industry, the Consumer Healthcare Products Association (CHPA) announced the new recommendation against using the drugs in children under 4.  The new age recommendation was based on an FDA analysis.  According to the Associated Press, agency officials said emergency room data shows that most of the problems with the drugs involve kids under 4.  However, the FDA has so far refused to release the data it used to reach that conclusion.

According to the Associated Press, some of the FDA's advisory panel members have questioned the agency's rationale in recommending the new age limit.  "There was no data suggesting that the drugs were effective in kids under 12," said Sean Hennessy, a professor of epidemiology and biostatistics at the University of Pennsylvania. "I don't see how that's a fully rational approach to the problem."

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