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GSK responds to rosiglitazone article

4th December 2007

GlaxoSmithKline (GSK) has issued a response to a recent article in Nature Medicine regarding rosiglitazone and bone in mice.

The firm notes that the article adds additional context concerning the potential role of thiazolidinediones (TZDs) in osteoclast activity, while adding that TZDs have already been studied in relation to bone fractures.

It notes that fractures have been previously reported in female patients taking TZDs, including rosiglitazone and pioglitazone, with precautions for fractures for both drugs communicated to healthcare professionals in Europe and the US.

“The European and US labels for rosiglitazone provide information about the incidence of fractures observed and state that the risk of fracture should be considered in the care of patients, especially female patients, treated with rosiglitazone,” GSK reports.

The company adds that observational studies of the effects of pioglitazone, rosiglitazone and troglitazone on bone density when used to treat type two diabetes have shown a reduction in bone mineral density.

In its own Adopt study, GSK reveals that women in its rosiglitazone treatment group experienced more bone fractures at peripheral sites – not associated with osteoporosis – than patients in the gylburide or metformin groups.

In July 2007, GSK presented an analysis of existing data regarding the risk of TZDs and heart failure, noting that the danger is already well-documented to physicians prescribing the compounds.

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