GSK statement on US Food and Drug Administration Pediatric Advisory Committee recommendations regarding Salmeterol

Untreated and uncontrolled asthma is an urgent public health issue and Serevent® (salmeterol xinafoate) and Advair® (fluticasone propionate and salmeterol) when taken as indicated help children and adults with asthma control their symptoms. As discussed at today’s meeting, Serevent should only be used as additional therapy for patients who continue to have symptoms on another controller as outlined in the product label.

GlaxoSmithKline believes the products are appropriately labeled, however we will continue to communicate with the US Food and Drug Administration regarding today’s discussion. There is no new safety information that changes the benefit-risk evaluation of Serevent or Advair which warrants another review at this time. GlaxoSmithKline is committed to the continued monitoring and safety evaluation of all of its products.

Asthma-related deaths in the U.S. have declined 29 percent since these medicines became available in the mid 1990s according to the Centers for Disease Control and Prevention. GSK has confidence in the established safety profile of Advair and Serevent when these products are used according to their labels, which are consistent with recently issued national treatment guidelines.

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