Search This Blog

Friday, February 19, 2010

FDA announces new safety labeling recommendations for long-acting beta2 agonists

The United States Food and Drug Administration (FDA), after continued analysis of clinical trial data on LABAs, has announced additional labeling requirements on formoterol and salmeterol, as well as the combination products that include these drugs.

Black box warnings are currently in place for both formoterol and salmeterol about the possible increased risk of death and limiting use to those patients whose asthma is not controlled on inhaled corticosteroids (ICS). Current labeling also cautions against use of LABAs as monotherapy for asthma and for management of acute exacerbations.

The new FDA labeling requirements mandate labeling language that LABAs are contraindicated as monotherapy, must be used in conjunction with ICS therapy, should be used for short durations to re-establish control of asthma, then discontinued, and must be used in a combination product for patients who require both LABAs and ICS to manage their asthma to ensure that both medications are used by the patient.

In the latest GINA guidelines (2009), it was proposed that LABAs should not be given as monotherapy, but as adjunct to ICS therapy. These recommendations were based on the paper of Nelson et al (Chest, 2006 Jan;129(1):15-26) and a thorough analysis of the literature. They are in line with the FDA announcement.

What do you think? Please feel free to post your own comments below. Topics and articles that you think would be of interest in our NBOP section and/or this blog can be sent to the JACI Editorial Office at

Monday, February 15, 2010

Estrogen Replacement and Asthma Risk

Is a significant risk of developing asthma a fair trade for getting rid of hot flashes and night sweats? An article published in the British journal Thorax reports that French women who used hormone replacement therapy (HRT) were 21% more likely to be diagnosed with asthma than those women who never used HRT. Women who used estrogen-only HRT were 54% more likely to develop asthma compared to their “natural” menopause counterparts.

Estrogen and asthma pathogenesis have been studied, but the findings are equivocal. Estrogen is known to have both inflammatory and anti-inflammatory effects, such as suppressing airway hyperresponsiveness, enhancing nitrous oxide synthetase metabolism, and inhibiting cortisone conversion to cortisol.

The authors suggest that the estrogen effects are likely to be a combination of these mechanisms interacting with the individual’s genetic background. The authors point out that their results on the increased risk associated with estrogen-only HRT must be evaluated in the context of other benefits associated with HRT in menopausal women.

What do you think? Please feel free to post your own comments below. Topics and articles that you think would be of interest in our NBOP section and/or this blog can be sent to the JACI Editorial Office at

Tuesday, February 9, 2010

To avoid or not to avoid?

The evidence is mounting. Early exposure to potential allergens is critical to the development of tolerance. In this blog, we talk about 3 articles that have appeared recently that basically deliver the same message: when it comes to infant feeding to avoid atopy, the jury is still out.

The leading allergy journal in Europe, Allergy, published an article by the EuroPrevall research consortium (a European Union funded project). Their literature review paper found that there is no overall evidence that supports European infant-feeding guidelines for allergy prevention. There was consensus that breastfeeding for 6 months is best for the infant, but its effect on allergy prevention is unknown.

Two Finnish research groups have come up with similar findings about the timing of introduction of solid foods. One article, in the US journal Pediatrics, shows that introduction of eggs, oats, and wheat after the age of 5 months is associated with food allergies later, and late introduction of potatoes and fish is associated with inhalant allergies.

The other article by Finnish researchers, published in the British Journal of Nutrition, reports on the results of a study of asthma risk, and oatmeal. The researchers followed a large cohort of children and parents for 5 years, and report that children introduced to porridge before 5 months of age were 64% less likely to have wheezing as toddlers compared to children who never ate it or ate it at an older age. It was also shown that infants that were fed fish at an early age had significantly lower incidence of allergic rhinitis by 5 years of age.

These findings stand in sharp contradiction to US and European infant-feeding guidelines that emphasize the introduction of solid foods at discrete developmental stages that begin at 6 months of age. Are we creating – unintentionally – our immune-impaired populations by being too avoidant of allergens?

What do you think? Please feel free to post your own comments below. Topics and articles that you think would be of interest in our NBOP section and/or this blog can be sent to the JACI Editorial Office at

Wednesday, February 3, 2010

Asthma and sports

The 2010 Winter Olympics kicks off on February 12th, in Vancouver, British Columbia, Canada. We’ve found some news items spotlighting issues of allergies and asthma for Olympic athletes.

The New York Times published an article on January 13, 2010, asking why as many as 50% of winter sport Olympians have exercise-induced bronchoconstriction (EIB). Yale University allergist, Christopher Randolph, MD, pointed out that EIB, in the absence of asthma, tends to occur in athletes who train for the greatest number of hours, especially in cold weather. So, does cold weather actually cause EIB?

The conventional wisdom has been that EIB is a constriction/dilation reaction to cold air, like numbing/tingling of the fingertips. More recently, researchers now consider the primary cause to be airway dryness. Abrupt moisture loss in the airways causes mast cell degranulation and cytokine release leading to acute inflammation. Recent research in EIB subjects points to dysregulation of aquaporin water channels (Chan et al., Chest 2008).

But this doesn’t answer the question of EIB prevalence in winter sport athletes. One new theory, mentioned by Dr. Randolph, suggests that EIB in winter sport athletes is a sports injury. Chronic inflammation associated with excessive exercise-related respiration may produce the airway injury.

A Canadian Broadcasting Corporation news article takes up the topic of athletes with allergic rhinitis. Dr. Donald Stark, an allergist in Vancouver, commented that February is alder tree pollen season in southwest B.C. He warned that athletes that are not allergic to alder may cross-react if they are sensitive to birch. This is a particularly problematic issue as over-the-counter medications can produce “doping” results, which would immediately disqualify the athlete. Olympic athletes are allowed to take pseudoephedrine, though blood titers cannot be higher than 150μg/ml.

On a sort of related, summer Olympic event note…
Belgian researchers published results in the European Respiratory Journal on their study of infant swimming and bronchiolitis. They found that infants younger than 2 years that swam in indoor or outdoor pools had increased risk of bronchiolitis compared to their non-swimming peers. The researchers suggested that early exposure to chlorine made the airways more sensitive and reactive to infection as well as allergens.

Children who swam in indoor pools had 3.5 times higher risk and children who swam in outdoor pools had twice the risk of bronchiolitis. Infant swimmers with a history of bronchiolitis also had increased risk of asthma and allergies later in life.

We want to hear from you! Please feel free to post your comments below. Topics and articles that you think would be of interest in our NBOP section and/or this blog can be sent to the JACI Editorial Office at