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Advair, Symbicort, Serevent and Foradil Get New Safety Warnings

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New label warnings for a class of asthma drugs known as known as long-acting beta agonists (LABAs) have been finalized. The U.S. Food & Drug Administration (FDA) requested the new safety warnings in February, and said it was aiming to reduce the use of the drugs. They agency says the drugs should only be used in the sickest asthma patients.

The drugs subject to the modified labels include Advair, Serevent, Foradil and Symbicort. According to Reuters, the FDA had to exercise new powers to order the changes on Advair and Serevent, both marketed by GlaxoSmithKline, as well as AstraZeneca’s Symbicort.

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 (made by Novartis and marketed by Merck & Co in the U.S.) only contain LABAs. These drugs are approved to treat people whose asthma isn’t well controlled by other drugs including inhaled corticosteroids.

Both Glaxo and AstraZeneca had resisted the changes, which caused the FDA to order them to do so, using authority Congress granted it in a 2007 law. This marks the eighth time the agency has used its new powers, Reuters said.

The FDA has been reviewing LABAs for the past several years, and their labels had already warned that they could increase the risk of asthma related death. The new warnings are aimed at informing both doctors and patients about how the products should ideally be used.

The new labels will state that:

• 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.

The new recommendations do not apply to the use of LABAs for COPD therapy, another approved use of the drugs.

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