Avandia May Get Bone Warning
GlaxoSmithKline diabetes drug Avandia (thiazolidinedione), already linked to heart ailments may get a warning label from U.S. regulators to reflect increased risks of bone fractures. Two tests linked the drug to broken bones in women. A trial in the June issue of Diabetes Care found that men on the product for an average of 16 months had lower bone mineral density in the spine and hips as well. Morgan Stanley's Andrew Baum said the new data will add to concerns about fractures. Researchers from the VA Medical Center and Louisiana State University in Shreveport, suggest that Avandia treatment is a risk and can contribute to a higher incidence of fractures. Baum said Avandia is “almost certain” to get a new warning about fracture risks in women on its label. An advisory panel of the U.S. Food and Drug Administration is scheduled to discuss Avandia at a meeting on July 30.
