The Food and Drug Administration (FDA) has linked four asthma treatments to an increased risk of asthma attacks, especially in children.
GlaxoSmithKline’s Serevent and Advair, Novartis AG and Schering-Plough’s Foradil and AstraZeneca’s Symbicort, all of which fall into a class of medications known as long-acting beta-agonists, or LABAs, were investigated in the study.
The agency said: “LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation and asthma-related hospitalisations.”
More than 60,000 patients took part in the trial, with 20 deaths being recorded.
The companies involved have defended the record of the treatments. Both Glaxo and Novartis said their drugs were safe when used with a corticosteroid, while AstraZeneca claimed Symbicort has a “favourable risk-benefit profile”.
LABAs have been the subject of a long-running FDA safety review.
The medicines regulator will vote on a course of action next week.
Copyright Press Association 2010
Food and Drug Administration