The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Eli Lilly Canada Inc.
Contact the company for a copy of any references, attachments or enclosures. |
| Health Canada Endorsed Important Safety Information on
Evista (raloxifene hydrochloride) |
May 18, 2006
Dear Health Care Professional:
| Subject: |
Association of Evista® (raloxifene hydrochloride) with Increased Risk of Mortality Due to Stroke in Postmenopausal Women at Increased Risk for Cardiovascular Disease: Preliminary Results from the RUTH Trial. |
Eli Lilly Canada Inc., following discussions with Health Canada, would like to inform you of important new safety information regarding Evista (raloxifene hydrochloride) resulting from the Raloxifene Use for The Heart (RUTH) trial.
The RUTH trial, a large-scale placebo-controlled study, investigated whether a 60 mg daily dose of raloxifene hydrochloride would reduce the risk of coronary events and the risk of invasive breast cancer in postmenopausal women with known heart disease or at high risk for a coronary event. The study included more than 10,000 women (average age = 67 years) from 26 countries who were followed for up to seven years. All women enrolled in RUTH had known heart disease or were at high risk for a coronary event.
- The RUTH study demonstrated an increase in mortality due to stroke for Evista compared to placebo. The incidence of stroke mortality was 1.5 per 1,000 women per year for placebo versus 2.2 per 1,000 women per year for Evista (p=0.0499).
- The incidence of stroke, myocardial infarction, hospitalized acute coronary syndrome, cardiovascular mortality, or overall mortality (all causes combined) was comparable for Evista and placebo.
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Important Considerations for Health Care Professionals:
- Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
- Evista is not indicated and should not be prescribed for the prevention or reduction of the risk of cardiovascular disease.
- The benefit/risk profile remains favourable for the majority of patients taking Evista for osteoporosis treatment and prevention.
- Women enrolled in the RUTH trial had either documented coronary heart disease, lower extremity arterial disease or the presence of risk factors known to increase the risk of coronary events, including age ≥ 70 years; hypertension; current smoker ≥ 10 cigarettes/day for 6 months; diabetes mellitus; hyperlipidemia i.e. LDL-C > 4.14 mmol/L or HDL-C < 1.16 mmol/L with TG > 2.82 mmol/L or on a lipid lowering drug.
- The risk-benefit balance of raloxifene in postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation, should be considered before prescribing raloxifene.
This Dear Health Professional Communication is posted on both the Eli Lilly Canada website at  www.lilly.ca and the Health Canada website at www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index_e.html.
Managing marketed health product-related adverse reactions depends on health care 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 death, stroke or other serious or unexpected adverse reactions in patients receiving Evista 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
Toll Free Number: 1-888-545-5972 or 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
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Sincerely,
original signed by
Loren D. Grossman, MD, FRCPC, FACP
Vice President, Research and Development
Eli Lilly Canada Inc.
Evista® is a registered trademark of Eli Lilly and Company, used under license.
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