Association between Long-Term Treatment with ^PrACTOS^® (pioglitazone hydrochloride) Tablets for Type 2 Diabetes Mellitus and Fractures in Women

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This is duplicated text of a letter from Eli Lilly Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on
^PrACTOS^® (pioglitazone hydrochloride)

April 18, 2007

Subject: Association between Long-Term Treatment with ACTOS^® (pioglitazone hydrochloride) Tablets for Type 2 Diabetes Mellitus and Fractures in Women

ACTOS^® (pioglitazone hydrochloride) tablets is a medication authorized for sale in Canada to control blood sugar levels in people with type 2 diabetes whose blood sugar levels have not been controlled by diet, exercise or other medications. Eli Lilly Canada, after discussions with Health Canada, would like to provide Canadians with new safety information regarding an increased number of bone fractures in women who participated in clinical trials with ACTOS^®.

A total of nineteen clinical trials using pioglitazone and other diabetes medicines or placebo have been analysed. The main outcomes of these trials were generally blood glucose control. A total of about 15,599 patients were enrolled in these studies. Findings from this analysis showed that significantly more pioglitazone treated women experienced at least one event of bone fracture than patients treated with either placebo or comparator medicines such as metformin or sulfonylureas i.e. gliclazide, glyburide or glimepiride (2.6% vs. 1.7% respectively). There was no increased risk of fracture identified from these clinical trials in men. The majority of fractures observed in women who received pioglitazone were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, lower leg). These fractures were in different sites from those typically associated with post-menopausal osteoporosis (e.g. fractures in the hip and spine).

Eli Lilly Canada has sent a letter to Canadian healthcare professionals informing them of this new safety information. You may view this letter on the Health Canada website. Eli Lilly Canada will continue to review new safety data for ACTOS^®, including post-marketing adverse event reports. Eli Lilly Canada will be working with Health Canada to further integrate new safety information in the Canadian Product Monograph.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving ACTOS^® should be reported to Eli Lilly Canada or Health Canada, at the following addresses:

Sincerely,

original signed by

Loren D. Grossman, MD, FRCPC, FACP
Vice President, Research and Development
Eli Lilly Canada Inc.

ACTOS^® is a registered trademark, under licence from Takeda Pharmaceutical Company Ltd.