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GSK defends labelling of asthma drugs

29th November 2007

GlaxoSmithKline (GSK) has defended the labelling of its Serevent and Advair asthma drugs, following calls by a US Food and Drug Administration (FDA) panel to provide more warnings applied to children.

GSK responded to the recommendations made by the FDA paediatric advisory committee, stating that it believed the products were appropriately labelled.

However, the pharmaceutical company confirmed that it would continue to communicate with the FDA regarding its advice.

GSK went on to outline that there had been no new safety information which had effected the benefit-risk evaluation of Serevent or Advair and so another review was not, at present, warranted.

The company indicated that Serevent should only be used as additional therapy for patients who continue to have symptoms on another controller as outlined in the product label.

GSK stated that asthma-related deaths in the US had declined by 29 per cent since the medicines had become available and that it had every confidence in the safety profile of the drugs when used according to the label.

This week, GSK acquired the over-the-counter marketing rights to Mevacor (lovastatin) from Merck, Sharp and Dohme.

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