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Dr. Gregory Pais, ND
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Home arrow Blog arrow JUST SAY NO

On Friday September 28, 2007 Food and Drug Administration safety officials released preliminary recommendations stating that young children should not take some commonly used cold and cough medicines. They went on to say that the "consult your physician" advice to parents on the labels be dropped. The review process behind these recommendations was a response to Baltimore city officials and the American Academy of Pediatrics, who suggested that the drugs are not only risky but also don't work in young children.

An FDA review of side-effect records filed with the agency between 1969 and September 2006, found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine, or ephedrine. 

Common pseudoephedrine drugs: Actifed, Advil Allergy Sinus, Advil Cold And Sinus, Aleve Cold And Sinus, Allegra D 24 Hour, Allegra-D 12 Hour, Children's Advil Allergy Sinus, Children's Advil Cold, Children's Motrin Cold, Chlor-Trimeton,  Claritin-D, Claritin-D 24 Hour, Drixoral Mucinex D, Sine-Aid IB, Sudafed 12 Hour,  Sudafed 24 Hour, Zyrtec-D 12 Hour.

The FDA also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine, or chlorpheniramine. Most of the deaths were children younger than 2.

Common diphenhydramine drugs: Benadryl Allergy, Sinus & Headache, Tylenol Severe Allergy, Tylenol Allergy Sinus Night Time.

Common brompheniramine drugs: Dimetapp Cold & FeverCommon chlorpheniramine drugs: Tylenol Allergy Sinus, Sudafed Cold & Allergy, Actifed Cold and Sinus, Sinutab Sinus Allergy, Theraflu Flu and Cold, Triaminic- Night Time, Vicks 44M Cough & Cold Relief, Comtrex Multi-symptom Cold & Cough Relief, Contact Severe Cold & Flu Maximum Strength, Theraflu Flu, Cold & Cough. Tylenol Cold Complete, Triaminic Severe Cold & Fever, Chlor-Trimeton Allergy.

This information comes out just as a Center for Disease Control and Prevention report found that more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period because of these drugs.

Also on Friday, the FDA gave drug companies until Oct. 31 2007 to stop making and selling any unapproved prescription medicines labeled for use by children younger than 6 that contain the painkiller and cough suppressant hydrocodone.
The move is part of a broader effort to remove from sale an estimated 200 unapproved prescription cough medicines made with the narcotic.

Manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008, the FDA said. It said the order applies to most of the hydrocodone formulations sold as cough medicines.

You know it's gotten serious when the FDA is moved to say something negative about such a frequently used class of drugs as cold, cough, and anti-histamines. I was just telling a patient the other day that these drugs weren't safe and actually were a deterrent to getting well. I guess the FDA agrees with me.


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