The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and
Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press
releases and other notices from industry as a service to health professionals, consumers, and other
interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD 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 AstraZeneca Canada Inc.
Contact the company for a copy of any references, attachments or enclosures. |
PUBLIC ADVISORY
Important Safety Information Regarding Casodex® 150 mg
Accelerated Deaths in Localized Prostate Cancer Patients
Health Canada has withdrawn its approval for CASODEX 150 mg for early
(localized) prostate cancer. |
![Astrazeneca Logo](/web/20061212002203im_/http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2003/images/astrazeneca.jpg)
August 19, 2003
In consultation with Health Canada, AstraZeneca Canada Inc. is advising health professionals
and the public of important new safety information related to the drug CASODEX 150 mg (3 x 50 mg
pills) for the treatment of early (localized) prostate cancer.
The results of a large on-going early prostate cancer study with CASODEX 150 mg have shown that
in a subgroup of 1627 patients with early prostate cancer there is an increase in the number of deaths
(196 versus 174) in the CASODEX 150 mg treated patients compared to those receiving no active treatment
(placebo).
Health Canada has withdrawn its approval for CASODEX 150 mg for early
(localized) prostate cancer.
Based on this data, it is recommended CASODEX 150 mg NOT be administered to patients in the early
phase of prostate cancer. Patients currently undergoing CASODEX 150 mg therapy for early prostate cancer
should consult their physician immediately and discontinuation of CASODEX should be discussed. It should
be noted that metastatic prostate cancer patients, taking CASODEX 50 mg per day are not affected by this
new information.
In November 2002, Health Canada issued a conditional approval for CASODEX 150 mg under a policy called
the "Notice of Compliance with Conditions". This approval reflects the promising nature of the first
results of the on-going studies in patients with this serious disease, but are yet to be confirmed.
Approval was based on study results which showed that in patients who would otherwise undergo "watchful
waiting" (whereby the patient is monitored and treatment is only started when there are signs that the
disease is getting worse), the immediate use of CASODEX 150 mg delayed the spread of prostate cancer when
compared with "watchful waiting" alone. CASODEX 150 mg was approved in Canada for some localized prostate
cancer patients unsuitable for surgery or radiotherapy that are at high risk of the disease spreading.
Further analysis, however, has shown that there is evidence of accelerated
deaths in patients with localized prostate cancer undergoing watchful
waiting and CASODEX 150 mg therapy. These deaths are unrelated to
prostate cancer, however association with CASODEX 150 mg therapy cannot
be ruled out.
In addition to advising patients, physicians and pharmacists of this safety information, AstraZeneca
is working with Health Canada to ensure this information is reflected in the product labelling.
For further information, members of the public may contact AstraZeneca's Customer Relations office
at 1 (800) 668-6000.
Media inquiries:
(AstraZeneca)
Stephanie Engel
(905) 804-5817
or
Felicia Shiu
at (905) 615-6865
Health Canada
Krista Apse
(613) 941-8189
Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
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 TPD web site or in The Canadian
Compendium of Pharmaceuticals and Specialties.
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