FDA Warns That Advair & Serevent Increase Risk Of Injury & Death; Require New Warnings

The U.S. Food & Drug Administration (FDA) issued another warning about asthma drugs Advair, Serevent, Symbicort and Foradil on February 18, 2010 saying that, based on clinical trials, “[the] use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma.” This is not the first time for the FDA to target asthma manufacturers.

New warnings & labeling changes

The FDA warned that kids and adults are at an increased risk of injury and death and will require manufactures (GlaxoSmithKline, which markets both Advair and Serevent; Merck and Novartis AG, which market Foradil; and AstraZeneca, which markets Symbicort) to revise their labels to warn of these risks.

Warnings. The new FDA warnings say that the asthma medications, which contain corticosteroids that are used to improve a patient's ability to breath freely and reduce asthma symptoms by relaxing muscles in the lung's airways, should be limited. FDA's Dr. Badrul Chowdhury said:

Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death.

Labeling changes. It will now require the manufacturers to change their products labeling with regard to asthma use as follows:

• The use of LABAs (long acting beta agonists used to treat both people with asthma or with chronic obstructive pulmonary disease (COPD).) is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
• LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
• Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

The FDA is requiring the manufacturers to conduct additional studies to determine the safety of using LABAs in combination with inhaled corticosteroids in order to adequately warn consumers about asthma drug side effects. It should be noted that African American adults seem to be at a greater risk of injury or death, although scientists still do not fully understand why. Perhaps new clinical information will provide those answers.

Advair Lawsuits / Serevent Lawsuits

Numerous Advair lawsuits and Serevent lawsuits have already been filed against manufactures after previous studies found a statistically significant increase in asthma-related deaths, respiratory-related deaths and combined asthma-related deaths or life-threatening experiences and the FDA required manufacturers to include black box warnings on the drugs. If your loved one has died due to the use of Advair, Serevent, Foradil, Symbicort or another salmeterol-based drug, contact a product liability attorney in your state to discuss your situation.