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FDA Cracks Down on Kids' Cough Medicine
Some Experts Want to End Sales of Over-the-Counter Cough and Cold Medicine for Children
October 2, 2008
Consumer groups and medical experts called on the FDA Thursday to pull children's cough and cold medications off the market or make them available only by prescription.
Last summer, the FDA warned consumers not to give cold medicines to children under age 2 because of serious and possible life-threatening side effects. Now officials are considering limiting sales of products intended for children up to age 6.
The FDA estimates that as many as 800 cough and cold medications are on the U.S. market. Companies sell an estimated 95 million packages of pediatric cough and cold medications each year.
Joshua Sharfstein, MD, urged FDA officials to take off the market cough and cold medicines for children under 6. He also said the regulators should recall millions of those packages currently on store shelves. "Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," he said.
Lack of Data on Cold Remedies for Kids
Most available cold remedies use combinations of different active ingredients, and most have not been well-tested in young children, critics said Thursday.
At the same time, about 7,000 children under 11 go to emergency rooms each year after taking cough and cold medicines, according to the CDC. Roughly two-thirds of those occurred after children drank medication while unsupervised, the agency said.
But several experts told the FDA Thursday that cold medicines have shown little benefit for children's cold symptoms, which usually clear up on their own without medicine.
"The available data show cough and cold products to be ineffective for children with cough and cold symptoms. In the absence of evidence of efficacy, any risk associated with these drug therapies is unacceptable," said David Bromberg, MD, a pediatrician from Frederick, Md., who testified on behalf of the American Academy of Pediatrics.
Source: WebMD Health News  "Nonprescription Cough and Cold Medicine Use in Children," Aug. 15, 2007. Schaefer, M.K. Pediatrics,Jan. 28, 2008. David Bromberg, MD, American Academy of Pediatrics. John K. Jenkins, MD, director, Office of New Drugs, FDA. CDC web site.
Dr. Iverson's Comment
Because of that all too recognizable fruity flavor that we remember as children, cough syrups have become more like a candy treat to children than medicine. Children have been rushed to the hospital for overdosing on these very powerful and dangerous medicines. 
For the most part I only recommend Nature cure principles for children. These include limiting mucus forming foods like milk, wheat, and soy products. I encourage water and herbal teas, chewable and fizzy vitamin C, as well as children doses of herbal medicine. Herbal cough drops and throat sprays work wonders!   I am ALWAYS impressed with the effects of hydrotherapy such as the application of hot and cold towels and steam baths with essential oils for fever, cough and cold symptoms.
Be well!
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