FDA Mandates New Safety Controls for Long-Acting Beta Agonists

From Medscape Medical News

By Robert Lowes

February 18, 2010 — The US Food and Drug Administration (FDA) announced today that manufacturers of long-acting beta agonists (LABAs) must now state on product labels that asthma patients must not take LABAs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.

The labels also must state that the LABAs should never be used alone in the treatment of asthma in adults or children.

Roughly 95% of asthma patients using an LABA receive it in combination with a corticosteroid in a single inhaled product such as Advair Diskus, Advair HFA, or Symbicort, according to the FDA.

As a result of the new warnings labels required by the agency, patients who gain control of their asthma through these combination corticosteroid products need to be switched to a corticosteriod alone or some other "controller" medication, with no LABA added.

Recent analyses of clinical trials show that LABAs are associated with a higher risk of severe worsening of asthma symptoms, resulting in hospitalization, intubation, and sometimes death for adults and children alike, according to the FDA.

"We think the greater public health benefit is to reduce the use of LABAs, but keep them available for patients who really need them," said John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research at a news conference today. "There is still a benefit to these drugs for patients who aren't absolutely controlled on asthma-control medications."

More information is available on the FDA Web site.

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Pill Shows Lasting Benefits Against Hay Fever

From Reuters Health Information

NEW YORK (Reuters Health) Feb 15 - A prescription pill approved in Europe for the treatment of grass pollen allergies seems to have lasting benefits, a new study finds.

The drug, called Grazax, offers an alternative to allergy shots. Dissolved under the tongue, the pills contain a small amount of grass-pollen extract. The drug is taken daily, starting several months before the start of the allergy season and continuing for three years thereafter.

In the new study, researchers looked at the medication's long-term effects in patients who had stopped using it after the recommended three years. They found that, compared with patients who had been given a placebo, Grazax users had one-quarter fewer hay fever symptoms one year after stopping the medication.

They also had less need for antihistamines and other allergy medications, according to a report in the January issue of the Journal of Allergy and Clinical Immunology.

These longer-term findings, the researchers write, support Grazax as a treatment option for people whose hay fever symptoms fail to improve with standard medication.

Dr. Stephen R. Durham, of Imperial College London in the UK, led the study, which was funded by Denmark-based ALK-Abello, the maker of Grazax. Durham and several co-researchers on the study have received research grants and other funds from the drug company.

The findings are based on 257 adults with grass pollen allergies, confirmed through allergy tests. They were randomly assigned to take either Grazax or inactive placebo tablets every day, beginning four to eight months before the next grass pollen season. They continued the therapy for three years.

Over those three years and for one year after stopping the treatment, the patients rated their daily symptoms and allergy medication use.

During the year following treatment, patients in the Grazax group reported a 26 percent reduction in symptoms like congestion and itchy, watery eyes compared with the placebo group. They also had a 29 percent reduction in medication use and gave higher ratings to their quality of life.

Those differences were similar to those seen during the three years of active treatment, according to the researchers.

During the last year on treatment, 15 percent of Grazax patients had side effects believed to be caused by the treatment -- the most common being itching and swelling in the mouth, ear itchiness and throat irritation.

A clinical trial aimed at winning FDA approval for Grazax is currently underway.

J Allergy Clin Immunol 2010;125:131-138.

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Ragweed Allergy Study

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Allergy Injections Schedule

These are our regular hours for giving allergy injections in our office.

Monday 8:30 AM - 4:00 PM
Tuesday 9:00 AM - 5:00 PM
Wednesday 9:00 AM - 4:00 PM
Thursday 9:00 AM - 6:00 PM
Friday 8:30 AM - 4:30 PM

We will periodically post changes that may be occur

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Secondhand Smoke Exposure Linked to Sleep Problems in Children With Asthma

From Medscape Medical News

By Laurie Barclay MD

January 20, 2010 — Exposure to secondhand smoke (SHS) is associated with increased sleep problems among children with asthma, according to the results of a study reported online January 18 and to be published in the February print issue of Pediatrics.

"Adult and adolescent smokers report difficulties with sleep," write Kimberly Yolton, PhD, from Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, and colleagues. "Young children who are exposed to tobacco smoke have poorer sleep quality. Children with asthma report more sleep problems and are more sensitive to the respiratory effects of tobacco smoke."

The goal of this study was to analyze the association between exposure to SHS and child sleep patterns among a group of 219 children with asthma who were enrolled in an asthma intervention trial and who had regular exposure to tobacco smoke at home. SHS exposure was measured with serum cotinine levels, and the Children's Sleep Habits Questionnaire was used to evaluate sleep patterns based on parental reports.

Statistical analyses allowed adjustment for covariates of age, sex, race, maternal marital status, education, income, prenatal tobacco exposure, maternal depression, Home Observation for Measurement of the Environment total score, household density, asthma severity, and use of asthma medications.

SHS exposure was associated with longer sleep-onset delay (P = .004), sleep-disordered breathing (P = .02), parasomnias (P = .002), daytime sleepiness (P = .022), and overall sleep disturbance (P = .0002).

"We conclude that exposure to SHS is associated with increased sleep problems among children with asthma," the study authors write. "As SHS exposure increased, parents reported that their children had longer delays in sleep onset, more-frequent parasomnias and sleep-disordered breathing, increased daytime sleepiness, and greater overall sleep disturbance."

Limitations of this study include lack of generalizability to children without asthma; wide variance of the degree of SHS exposure; sleep data based only on parental reports; and lack of information on prematurity, which could be an important contributor to sleep problems.

"We report significant associations between SHS exposure, as measured with a biological marker (serum cotinine levels), and sleep problems in children with asthma," the study authors conclude. "Reduction in SHS exposure is an area with the potential for significant impact in the pediatric population."

The National Institutes of Health supported this study. The study authors have disclosed no relevant financial relationships.

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Allergy Shots - Jan 07, 2010

Due to inclement weather and hazardous road conditions we will be closing early today. Allergy injections will not be given today after 3 pm. Drive carefully.

Preventing Influenza Transmission at Home

A recent article at the Annals of Internal Medicine published an article studying the use of hand hygiene and facemasks in preventing flu transmission at home. The investigators from the University of Hong Kong School of Public Health randomized household members of patients diagnosed to have influenza, to three arms - control group(lifestyle measures), control plus hand hygiene only, and control plus hand hygiene and facemasks. The findings revealed that hand hygiene and facemaskes can reduce influenza virus transmission if implemented early after symptoms start in the index household member. The full article can be reviewed at the Annals of Internal Medicine site.

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