Business | General
Takeda reports its diabetes drug causes more fractures in women
Women taking Takeda Pharmaceutical Co. Ltd's. pioglitazone drug for diabetes reported more fractures than those taking a placebo or another drug in clinical trials, the company and US health officials said in a notice to physicians released on Friday.
- Reuters
- Published: 00:00 March 11, 2007
- Most of the fractures found in the clinical trials were in the forearm, hand, wrist, foot, ankle or leg
- The analysis of trial data included more than 8,100 patients taking pioglitazone, and over 7,400 patients taking a placebo or alternative drug
- Due to the limitations of the existing data set, multiple known risk factors for fractures cannot be excluded as confounding variable.
- Last month, GlaxoSmithKline Plc wrote to US doctors warning of an increased bone fracture risk associated with its diabetes drug Avandia, which is in the same class of drugs as pioglitazone.
Washington: Women taking Takeda Pharmaceutical Co. Ltd's. pioglitazone drug for diabetes reported more fractures than those taking a placebo or another drug in clinical trials, the company and US health officials said in a notice to physicians released on Friday.
Pioglitazone is an active ingredient in Actos, Actoplus met and duetact, all sold to treat diabetes.
"Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products," said the notice posted on the US Food and Drug Administration's website.
Most of the fractures found in the clinical trials were in the forearm, hand, wrist, foot, ankle or leg, the notice said.
Analysis
The analysis of trial data included more than 8,100 patients taking pioglitazone, and over 7,400 patients taking a placebo or alternative drug, the FDA said.
"The observed excess risk of fractures for women in this data set on pioglitazone is therefore 0.8 fractures per 100 patient-years of use," Takeda's letter to physicians said.
The company added that "the explanation for this finding is currently not known."
"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," the letter said.
There was no increased risk of fracture identified in men.
Last month, GlaxoSmith-Kline Plc wrote to US doctors warning of an increased bone fracture risk associated with its diabetes drug Avandia, which is in the same class of drugs as pioglitazone.
Takeda spokeswoman Jocelyn Gerst said the company was working with the FDA to develop appropriate language about the fracture risk to add to labels for the pioglitazone drugs.
The FDA posted the notice about pioglitazone on the web at http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actos.
Injuries mostlyoccur in limbs
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