[e-farmacos] FDA: rosiglitazona y fracturas oseas

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados amigos,

La FDA acaba de publicar la informacion remitida a los profesionales sanitarios de EE.UU. sobre los resultados del ensayo clinico ADOPT, en el que se administraba  rosiglitazona sola comparada con el uso de metformina  o gliburida.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.

Read the complete MedWatch 2007 Safety summary, including a link to the GSK Dear Healthcare Professional letter, at: 

Mas informacion en:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone 

Un abrazo,

Mariano Madurga
AEMPS, Div FEpi y FV
mmadurga@agemed.es