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Actos (Pioglitazone) Tablets - Evaluation of Safety Data Showed Increased Incidence of Fractures in Female Patients
BETHESDA, MD -- March 9, 2007 -- 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
SOURCE: FDA
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