Meridia (sibutramine) Capsules - Voluntary Withdrawal from the Canadian Market - For Health Professionals

Starting date:

October 14, 2010

Posting date:

October 18, 2010

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002318

This is duplicated text of a letter from Abbott Laboratories, Limited.
Contact the company for a copy of any references, attachments or enclosures

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate)

October 14, 2010

Subject: Voluntary withdrawal of Meridia^® (sibutramine) capsules from the Canadian market.

Dear Health Care Professional,

Abbott Laboratories, Limited has voluntarily withdrawn Meridia (sibutramine hydrochloride monohydrate) capsules from the Canadian market. Abbott's decision was reached after discussion with Health Canada and comes in light of data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, a large study that suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients at high risk of cardiovascular events.

• Prescribers should not issue any further prescriptions for sibutramine.
• Pharmacists should stop dispensing the product.
• Patients who are currently being treated with sibutramine should discontinue treatment and be advised to make an appointment with their doctor at a convenient time to discuss alternative measures to lose weight, including use of diet and exercise regimes.

Further information on SCOUT:

SCOUT was a randomised, double-blind, placebo-controlled study, with a six week lead-in period during which all participants received sibutramine.  The study was conducted as a post-approval commitment to the European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) to evaluate the cardiovascular safety of long-term sibutramine use.

The study included approximately 10,000 overweight or obese patients, aged 55 years or older, at high risk of cardiovascular events. The majority of the patients enrolled had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling. In the study, these high-risk cardiovascular patients were treated with sibutramine for up to 6 years.

Patients treated with sibutramine experienced a 16% increased risk of a primary outcome event of non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest, or cardiovascular death (561/4906, 11.4%) compared with placebo-treated patients (490/4898, 10.0%) (hazard ratio 1.162 [95% CI 1.029, 1.311]; p=0.015). This result was attributed to an increased risk of non-fatal myocardial infarction and stroke.

Call for reporting:

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them.  Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.  Any case of serious heart-related adverse events or other serious or unexpected adverse reactions in patients receiving Meridia^® should be reported to Abbott Laboratories, Limited or Health Canada.

Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Québec H4S 1Z1
Telephone: (800) 361-7852
Fax: 514-832-7824 or 1-866-514-7824 (Toll-free)

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    • Health Canada
    • Postal Locator 0701E
    • Ottawa, Ontario   K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Canada at: Marketed Health Products (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Abbott reiterates its commitment to the health and safety of patients and the delivery of quality products. Should you have any questions or require additional information regarding Meridia^®, please contact Abbott at 1-800-361-7852 and ask for the Medical Information Department.

Sincerely,

original signed by

A. Tom Koutsavlis, MD, MSc, CSPQ, FRCPC
Medical Director
Abbott Laboratories, Limited