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> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 3/9/2007 10:24:54 AM > Subject: FDA - MedWatch - Actos (pioglitazone) Tablets - Evaluation of Safety Data Showed Increased Incidence of Fractures in Female Patients > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > Takeda and FDA notified healthcare professionals of recent safety data > concerning pioglitazone-containing products. The results of an analysis > of the manufacturer's clinical trial database of pioglitazone showed > more reports of fractures in female patients taking pioglitazone than > those taking a comparator (either placebo or active). The majority of > fractures observed in female patients were in the distal upper limb > (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and > tibia). There were more than 8100 patients in the pioglitazone-treated > groups and over 7400 patients in the comparator-treated groups. The > duration of pioglitazone treatment was up to 3.5 years. Healthcare > professionals should consider the risk of fracture when initiating or > treating female patients with type 2 diabetes mellitus with > pioglitazone-containing products. > > Read the complete MedWatch 2007 Safety summary, including links to the > Manufacturer's Dear Healthcare Provider Letter regarding this issue at: > http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actos > > _________________________________________________________________ > > 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
