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No OTC Cold Meds for Kids Under Four, Drug Makers Say

Oct 7, 2008 | Parker Waichman LLP

Manufacturers of over-the-counter (OTC) children's cold medicines warned today that the drugs should not be given to kids younger than four-years-old.  The advice, announced by the Consumer Healthcare Products Association on behalf of the industry, came less than a week after a Food & Drug Administration (FDA) advisory panel met to discuss the safety of OTC children's cold medicines, which have been tied to accidental overdoses and deaths.

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.

At last week's FDA advisory panel meeting, pediatricians had pushed for an all-out ban on children's cough medicines.  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 given to children under six, but said children older than 2 could keep taking the medications while studies investigating their safety and effectiveness were being conducted.

According to the Consumer Healthcare Products Association, drug makers will also add a warning to their OTC children's cold medicines that parents should not give children antihistamines to make them sleepy.  Antihistamines are among the ingredients used in OTC cold medicines. Many accidental overdoses occur when parents administer two or more drugs to their child – for example, one to treat fever and another for a cough and stuffy nose – without realizing that the medicines contain some identical ingredients. That often results in children receiving a dangerously high dose of an active ingredient, such as an antihistamine.

Manufacturers also plan on expanding an educational campaign aimed getting parents to be more careful in giving their kids cough and cold medicines.

In October 2007, some drug makers removed infant versions of the medications of the market. The medicines recalled at that time 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.

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