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FDA To Consider New Rules for Children's Cold Medicines

Aug 25, 2008 | Parker Waichman LLP

The rules regulating over-the-counter children's cold medicines are about to be revised by the Food & Drug Administration (FDA), the agency announced late last week.  Concern has been growing over the past several years that over-the-counter cold medicines meant for child are ineffective and unsafe, and many patient advocates hope the impending rule changes could ultimately lead to the drugs being removed from the market.

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.

Knowing the FDA warning was coming, some drug manufacturers had already taken steps to remove their infant cold medicines from the market. The medicines recalled in October 2007 included Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand. Pediacare, Dimetapp and Little Colds brand products were also recalled.

The FDA is still reviewing the safety of similar cold medicines in children ages 2-11.  For now, many doctors advise parents to avoid use of such medications in children under 6 years old.

According to The Washington Post, the FDA will hold a special hearing Oct. 2 to consider a number of issues.  Chief among them are the types of studies that should be done to evaluate the safety and effectiveness of children's cold medicines.  Also on the agenda is the question of whether the drugs should  remain available without a prescription.  Dosage and ingredient combinations will also be discussed.

Some patient advocates are hoping that the FDA will finally take these dangerous drugs off of the market.  In March 2007, a group of pediatricians filed a petition asking the FDA to restrict the use of the products.  The group cited a lack of evidence that the drugs work and growing evidence that they can cause a host of side effects, including hallucinations, seizures, trouble breathing, heart problems and other complications, including deaths.

But the drug industry insists that the drugs can benefit older children, and is expected to pressure the FDA to keep them on the market.


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