Cough and Cold Preps for Kids under fire by the FDA

For decades cough and cold medications have been marketed for our kids with the implication that they are ‘pediatrician recommended’ and that they are both safe and effective. The reality is that all 12 scientific studies conducted since 1985 on children under 12 found no difference from placebo. Are these ineffective medicine safe? The CDC recently released a 2 year study that found over 1500 ER visits related to cough and cold medications in children under 2 years of age. Today Dr Jim speaks with Dr Kenneth Kwon, a board certified pediatrician and Director of Pediatric Emergency Medicine at CHOC at Mission and University of California, Irvine Medical Center. Together, they will explore the real issues and tell you safe ways to treat your kids when they suffer from cold symptoms.

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One thought on “Cough and Cold Preps for Kids under fire by the FDA”

  1. On a related question…

    Yes there are some good studies that show Zicam (intra-nasal GEL) reduces the length of the common cold.

    Here’s one…
    Ear Nose Throat J. 2000 Oct;79(10):778-80, 782.

    Zinc nasal gel for the treatment of common cold symptoms: a double-blind, placebo-controlled trial.
    Hirt M, Nobel S, Barron E.

    Center of Integrative Medicine, Tarzana, Calif. 91356, USA.

    Effective treatment for the common cold have been difficult to develop because so many different types of virus are responsible for this condition. Oral zinc has been studied as a possible means of preventing or alleviating symptoms, with mixed results. We studied a new approach to zinc therapy–an over-the-counter nasal gel formulation (Zicam)–to independently evaluate its efficacy as a treatment for the common cold. Our study was conducted at four sites over a 5-month period. The study group consisted of 213 patients with recent-onset(< or = 24) cold symptoms; 108 patients received zinc therapy, and 105 reviewed placebo. Symptom charts were used to track the duration and severity of each patient's symptoms. At study's end, the duration of symptoms was 2.3 days (+/-0.9)in the zinc group and 9.0 days (+/-2.5)in the control group -- a statistically significant difference (p <0.05). These results provide evidence that zinc nasal gel is effective in shortening the duration of common cold symptoms off when taken within 24 hours of their onset. BUT not all Zinc is created equal

    Treatment of Naturally Acquired Common Colds with Zinc: A Structured Review

    Thomas J. Caruso,Charles G. Prober, and Jack M. Gwaltney, Jr.

    Stanford University School of Medicine and Department of Pediatrics, Stanford University School of Medicine, Stanford, California, and Department of Internal Medicine, University of Virginia School of Medicine, Charlottesville

    Received 19 March 2007; accepted 1 May 2007; electronically published 20 July 2007.

    Background. Over the past 20 years, the use of zinc as an over-the-counter alternative therapy for the common cold has vastly grown in popularity. Recent reports of potentially permanent anosmia caused by intranasal zinc therapy warrant careful analysis of the therapeutic effects of zinc.

    Methods. A search of the Medline database (including articles published during 1966–2006) for studies of zinc and the common cold produced 105 published reports. Fourteen were randomized, placebo-controlled studies that examined the effect of zinc lozenges, nasal sprays, or nasal gels on naturally acquired common colds. Eleven features of experimental design affecting signal quality, chance, bias, and blinding were used to evaluate the 14 placebo-controlled studies. These criteria were validated case definition, quantifiable hypothesis, sample size calculation, randomized assignment, double blinding, proof of blinding, measurement of compliance, measurement of dropout rate, analysis by intent to treat, description of methods of analysis, and measurements of probability. Equal weight was given to each criterion, because failure to meet any one could potentially invalidate the findings of a clinical trial.

    Results. Four studies met all 11 criteria. Three of these studies reported no therapeutic effect from zinc lozenge or nasal spray. One study reported positive results from zinc nasal gel. Of the remaining 10 studies, 6 reported a positive effect and 4 reported no effect. Intent-to-treat analysis was the most common criterion not met.

    Conclusions. This structured review suggests that the therapeutic effectiveness of zinc lozenges has yet to be established. One well-designed study did report a positive effect of zinc nasal gel.

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