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Advair and Other Asthma Medication Get New Warnings

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Long-acting-beta-agonists such as Advair, Foradil, Symbicort, Serevent, Brovana, Perforomist are being required to update their Black Box warnings after the FDA reviewed new studies linking LABAs to an increase in asthma related death. The new warning explicitly say that LABAs should not be used when asthma is under control from other medication, should only be used with other long term asthma therapy such as an inhaled corticosteroid.

Drug manufacturers were informed of the new recommended changes in February of 2010 and some have gone on to change their labeling. Merck (Foradil) had their new labeling approved on 6/2/2010. GlaxoSmithKline (Advair) and AstraZeneca (Symbicort) have resisted changing their labels and have raised objections to the FDA. These objections led the head of the FDA’s pulmonary division to “[order] the involved companies to make labeling changes capturing these new recommendations.”

Our firm is investigating all cases involving LABA’s. If you or a loved one has been injured as a result of taking one of these drugs, contact a lawyer to inform you about your rights. Below is the new approved label for Foradil and is probably indicative of what all the new labels will look like.

Foradil Label.pdf

The FDA’s statement says labeling must include:

Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.

LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.

Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.

Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.

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