GSK alerts US prescribers to Avandia problems

26 February 2007

UK drug major GlaxoSmithKline has sent a letter to US prescribers warning of an increased risk of bone fracture associated with the use of its diabetes drug Avandia (rosiglitazone maleate), after the large-scale ADOPT trial found an unexpected rise in peripheral fractures, mainly of the foot and upper limbs. The Avandia franchise contains three fixed-dose, single-pill products: Avandia, Avandamet (Avandia and metformin) and Avandaryl (Avandia and glimepiride). In third-quarter 2006, total sales of these products jumped 11% on the like, year-ago period to $378.0 million. In a note to investors, pharmaceutical sector analysts at Lehman Brothers said that the Dr Doctor letter would have no impact on Avandia revenue, noting that, while competitors may seek to counter the bone fracture risk for their own products, the lack of long-term data will make this difficult.

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