Dilute Bleach Baths Plus Intranasal Mupirocin Eases Eczema Severity in Children

From Reuters Health Information

NEW YORK (Reuters Health) Apr 28 - In children with severe atopic dermatitis prone to infections, a regimen of dilute sodium hypochlorite baths and intermittent intranasal mupirocin reduces disease severity, according to physicians at the Feinberg School of Medicine in Chicago.
"We and others have found anecdotally the addition of dilute sodium hypochlorite baths to be helpful in decreasing infection rates and disease severity" in children with eczema, Dr. Amy S. Paller and associates note, but theirs is the first controlled trial of this strategy.

Their study in the May issue of Pediatrics included 22 patients ages 9 months to 17 years with moderate to severe atopic dermatitis and bacterial skin infections. On average, one third of body surface area was affected, and the mean Eczema Area and Severity Index (EASI) score was 19.7. Lesions in most patients were positive for Staphylococcus aureus.

All patients were initially treated for 2 weeks with oral cephalexin, and continued topical anti-inflammatory medication and emollient therapy throughout the 3-month trial.

Nine patients were assigned to the treatment arm, and they bathed in a dilute bleach solution for 5-10 minutes twice a week; the dilution was 0.5 cup of 6% bleach in 40 gallons water, with final concentration 0.005%. Additional plain-water baths were not restricted. In this group, mupirocin ointment was applied intranasally twice daily for 5 consecutive days per month.

Thirteen control patients bathed in plain water and used petrolatum instead of mupirocin.

Compared to the control group, the treatment group showed significantly greater improvement on the EASI scores: -10.4 vs -2.5 at 1 month (p = 0.017) and -15.3 vs -3.2 at 3 months (p = 0.004).

The percentage of body surface area affected also significantly declined in the treatment group, by 23.7% at 3 months, versus 3% in the placebo group (p = 0.004).

Tolerability to the dilute bleach baths was "excellent," the authors say, although early on, infected lesions were made more painful. One patient who complained of skin irritation stopped the baths. However, after he developed a methicillin-resistant S. aureus skin infection requiring hospitalization, he resumed treatment, with no reported adverse effects.

Active treatment did not eradicate S. aureus, however, leading Dr. Paller and her team to suggest that longer duration of this treatment strategy may be required.

Pediatrics 2009;123:e808-e814.


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Due to vacations we will not be giving allergy injections at Fragge Allergy and Asthma Clinics on these dates

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New Safety Labelling for Leukotriene Modifiers

This article was taken from WebMD Health News

June 12, 2009 — The FDA today asked makers of Singulair, Accolate, Zyflo, and Zyflo CR to include a precaution on those drugs' labels about reports of behavior and mood changes.

Singulair is used to treat asthma and symptoms of allergic rhinitis. Accolate, Zyflo, and Zyflo CR are used to treat asthma.

All four drugs are leukotriene inhibitors, which affect the leukotriene pathway, which is involved in the body's response to inflammatory stimuli (such as breathing in an allergen).

The FDA notes that some patients using those drugs have reported neuropsychiatric events (behavior or mood changes) including agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

The FDA has already reviewed data from clinical trials about suicide risk in patients taking leukotriene inhibitors.

In that review, which the FDA released in January 2009, the FDA said it found no sign of a link between Singulair, Accolate, Zyflo, or Zyflo CR and suicide risk. At the time, the FDA said it was still reviewing clinical data on other behavioral and mood events.

FDA's Advice

On its web site, the FDA has posted the following advice about leukotriene inhibitors for patients and health care providers:

Patients and health care professionals should be aware of the potential for neuropsyschiatric events with these medications.

Patients should talk with their health care provider if these events occur.

Health care professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Singulair is made by the drug company Merck. In a statement posted on its web site, Merck says that it has updated Singulair's prescribing information about adverse events reported after the drug went on the market, including the types of neuropsychiatric events mentioned today by the FDA.

"Merck will continue to work with the FDA to revise the prescribing information for Singulair in the United States to include a precaution related to those events," states Merck, adding that it is "confident in the safety and efficacy of Singulair, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago."

Accolate is made by AstraZeneca. Zyflo and Zyflo CR are made by Cornerstone Pharmaceuticals. Those drug companies were not immediately available for comment on the FDA's label change request.

SOURCES:

News release, FDA.

WebMD Health News: "FDA: No Suicide Risk From Singulair."

Statement, Merck.

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FDA Recall

The U.S. Food and Drug Administration (FDA) today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

For more information visit
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm

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