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Warnings for Long-Acting Asthma Drugs Take Effect

Jun 3, 2010 | Parker Waichman LLP

New warnings for the inhaled asthma drugs Advair, Serevent, Foradil and Symbicort have been finalized by the U.S. Food & Drug Administration (FDA). The new warnings were requested by the agency in February, but 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.

All of these drugs are known as long-acting beta agonists (LABAs). 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 both people whose asthma isn’t well controlled by other drugs including inhaled corticosteroids.

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

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. In February, the FDA said it was aiming to reduce the use of the drugs, and that they should only be used in the sickest asthma patients.

The new warnings are aimed at informing both doctors and patients about how the products should ideally be used. The new recommendations in the updated labels state:

• 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 label warnings are effective immediately and will be online, but it was unclear how long it would take for the new cautions to be added to actual products, the FDA said

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.


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