New Restrictions on Serevent, Advair, Symbicort and Foradil

<"">Serevent, <"">Advair, Symbicort and <"">Foradil – asthma medications known as long-acting beta agonists (LABAs) – are being subjected to new safety restrictions, the U.S. Food & Drug Administration (FDA) announced yesterday.

LABAs prevent the release of substances in the body that cause inflammation of airways in the lungs. Advair and Symbicort use a LABA with an inhaled steroid; Serevent and Foradil (marketed in the U.S. by Schering-Plough Corp.) only contain LABAs. These drugs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations announced by the FDA only apply to the use of LABAs in the treatment of asthma.

The new requirements are based on FDA analyses of clinical trials showing that 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.

“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,” Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research, said in a statement announcing the new restrictions.

As a result of the FDA’s actions, the labels for Serevent, Advair, Symbicort and Foradil will be required to reflect the following:

• The use of LABAs 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 will also be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, the FDA said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

According to the FDA, manufacturers of these drugs will be required to include a warning on their labels that they should never be used alone in the treatment of asthma in children or adults.

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