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

Starting date:

April 18, 2007

Posting date:

May 7, 2007

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000486

This is duplicated text of a letter from Eli Lilly Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

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).

• Findings from this analysis of nineteen trials 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% for pioglitazone vs. 1.7% for placebo or comparator medicines).
• There was no increased risk of fracture identified in men.
• Patients (especially women) should speak with their doctor about the risk of fracture and continue their medication until they have consulted with their doctor about their treatment options.

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:

Customer Response Centre

Eli Lilly Canada Inc.

3650 Danforth Avenue

Toronto, Ontario

M1N 2E8

Tel.: 1-888-545-5972

Fax: 1-888-898-2961

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

Health Canada

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Tel: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866-234-2345

Fax: 866-678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.



For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Tel: 613-954-6522

Fax: 613-952-7738

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.