Takeda diabetes drug patient fractures

Mon, 12 Mar 2007
A note to physicians issued by Takeda Pharmaceuticals and US health officials indicates that women who take pioglitazone (a type of diabetes drug which is the active ingredient in duetact, actos and actoplus) reported higher levels of fractures than those who took placebos or other drugs during clinical trials.

The US Food and Drug Administration posted a notice on their website, which included the sentence: "Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products."

The notice came following a trial of over 8,000 patients taking pioglitazone and over 7,400 who took a placebo or an alternative drug. The Takeda letter continued: "It should be noted that none of the pioglitazone studies in the database addressed, or were designed to study, the effect on bone, but fractures were collected as adverse events. Due to the limitations of the existing data set, multiple known risk factors for fractures cannot be excluded as confounding variables."
Leave a Comment
Login via Facebook, Yahoo! and Hotmail
or
Have your full say in the Diabetes Forum
Your comments may be moderated. Please report any spam, illegal, offensive or libellous posts.