This Just In: FDA has Removed Box Warning for Combination Asthma Inhalers

Posted on: 29 December, 2017

Drug

This past week, the US Food and Drug Administration ruled to remove the Black Box Warning about asthma-related deaths for medications that contain both inhaled corticosteroids (ICS) and long acting beta-agonists (LABA) because data has shown these medication are both safe and effective.

This decision is based on a review of 4 large multicenter, randomized controlled, double blinded trials involving 41,297 patients. Results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone.

This decision reaffirms what allergists have seen in practice, that patients with asthma benefit from combination inhalers as it has been shown that taking the medications decrease rate of exacerbation and hospitalization among other benefits.

Make sure to follow and like us on social media including facebook, twitter and instagram to get the latest breaking news in allergy and immunology.

Conditions Treated

Allergy Shots

Allergy immunotherapy, also called “allergy shots,” is prescribed to modify the immune system’s response to allergens with the goal of minimizing and/or preventing an allergen initiated inflammatory response.
Allergy Drops & Tablets

Allergy drops, and tablets are two forms of sublingual immunotherapy that are injection-free alternatives to allergy shots. Both contain environmental allergen such as pollen, dust mites, molds, cat, or dog.
Asthma

Asthma is a chronic inflammatory lung condition that usually starts in childhood but can occur at any age. Allergists are considered the experts in asthma and diagnose this condition by history, exam and breathing tests of the airways.
Allergy & Sinus

Allergic rhinitis is one of the most common chronic conditions in the US. Individuals with allergic rhinitis develop allergy antibodies (IgE) targeted against allergens including pollen, animal proteins, dust mites, mold, and insect droppings.
Food Allergy

Food allergy affects 5% of children and 4% of adults in the United States and is defined as an adverse health event that is immune mediated and occurs reproducibly. Individuals with IgE mediated food allergy develop allergy antibodies (IgE) targeted against food allergens.
Allergic Rashes

Atopic dermatitis is a chronic, relapsing inflammatory skin disorder that usually starts at age < 5 years. It is characterized by itchy skin that becomes inflamed with scratching. For this reason, atopic dermatitis is known as the “itch that rashes.”
Other Conditions