GlaxoSmithKline has received a letter from the US Food and Drug Administration directing revisions to product labelling for its respiratory products Serevent and Advair. The letter concludes discussions between GSK and the agency following US FDA advisory committee meetings regarding the safety profile of long-acting beta2-agonists in the treatment of asthma, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair. The changes communicated by the US FDA reflect class labelling for all LABA containing products and are specific to product labels in the US.

GSK will work quickly to implement changes described in the US FDA's correspondence and communicate these changes to healthcare providers. Advair and Serevent remain important treatment options for appropriate patients with asthma and COPD.