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Hydrea (hydroxyurea capsules) - Advisories, Warnings and Recalls for Health Professionals
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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 Bristol-Myers Squibb Canada.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on
Hydrea* (hydroxyurea capsules)
March 1, 2006
Subject: Potential Risk of Cutaneous Vasculitic Toxicities associated with the use of HYDREA* (hydroxyurea capsules)
Dear Health Professional,
Bristol-Myers Squibb Canada, following discussions with Health Canada, is writing to inform you of post-marketing case reports of cutaneous vasculitis toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea. Most often these case reports occurred in patients with a history of, or currently receiving, interferon therapy.
In response to these reports, we are working with Health Canada to revise the WARNINGS, ADVERSE REACTIONS and INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL sections of the Product Monograph for HYDREA* to include the following.
WARNINGS
Other
Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxyurea should be discontinued if cutaneous vasculitic ulcerations develop and alternative cytoreductive agents should be initiated as indicated.
ADVERSE REACTIONS
Dermatologic
Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy (see WARNINGS).
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
To minimize the risk of exposure, always wear impervious gloves when handling bottles of HYDREA capsules. This includes handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspections, transport within a facility, and dose preparation and administration.
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 serious or unexpected adverse reactions in patients receiving HYDREA* should be reported to Bristol Myers Squibb Canada or Health Canada at the following addresses:
Bristol Myers Squibb Canada
2365 Cote-de-Liesse
Saint-Laurent (Quebec) - H4N 2M7
Tel: 1-866-463-6267
Fax: 1-888-267-6211
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:
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Tel: (613) 941-3171
Fax: (613) 941-1365
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
This letter is posted on the Bristol Myers Squibb Canada website at 
www.bmscanada.ca. The revised Product Monograph for HYDREA* will be placed on the website upon approval.
If you have any questions, please contact the Medical Information Department at Bristol Myers Squibb Canada at Telephone number 1-866-463-6267 and Fax number 1-888-267-6211.
Sincerely,
original signed by
Dan Chiche, MD
Vice-President, Scientific Affairs
Bristol Myers Squibb Canada
