> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 2/21/2007 8:46:04 AM > Subject: FDA MedWatch: Avandia (rosiglitazone maleate) - Increased incidence of fractures in females noted in clinical trial > > 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: > > http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone > > _________________________________________________________________ > > To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [EMAIL PROTECTED], to your address book. > > Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch. > > To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm > > To unsubscribe from this listserve: > https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
