Public Communication - Health Canada Endorsed Important Safety Information on Ketek(telithromycin)
UPDATED INFORMATION on the antibiotic KETEK(R)
(telithromycin)
LAVAL, QC, Sept. 5 /CNW Telbec/ - Sanofi-aventis Canada Inc., in
consultation with Health Canada, would like to inform Canadian
consumers of important new changes regarding the antibiotic
KETEK(R) (telithromycin).
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Do not take the antibiotic KETEK(R) to
treat bronchitis, sinusitis,
tonsillitis or pharyngitis (sore
throat).
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Upon review of the available safety information, including
reported cases of severe liver problems, Health Canada has
determined that the antibiotic KETEK(R) should no longer be
prescribed or used to treat bronchitis, sinusitis,
tonsillitis/pharyngitis (sore throat). If you are prescribed
KETEK(R) for any of these conditions, ask your doctor about using
other antibiotics instead.
KETEK(R) can still be used to treat community-acquired pneumonia
("CAP"). Before taking KETEK(R), discuss the possible side effects
with your doctor, such as liver injury, fainting and difficulty
seeing properly.
You should not take KETEK(R) if you have myasthenia gravis (a
disease involving muscle weakness) or if you have had jaundice,
hepatitis, or other signs of liver injury while or after taking
KETEK(R) or macrolide antibiotics (such as clarithromycin
(Biaxin(R)), azithromycin (Zithromax(TM)) or
erythromycin).
Complete product information will be available in the official
Canadian Product Monograph for KETEK(R) (see Part III: CONSUMER
INFORMATION). The revised Product Monograph will be posted at
www.sanofi-aventis.ca as soon
as it is available.
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 liver-related problems, exacerbations of
myasthenia gravis, visual disturbances, fainting or other serious
or unexpected adverse reactions in patients receiving KETEK(R)
should be reported to sanofi-aventis Canada Inc. or Health Canada
at the following
addresses:
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Any suspected adverse reaction can be
reported to:
sanofi-aventis Canada Inc.:
Toll-free telephone: 1-800-265-7927
Internet: www.sanofi-aventis.ca
Regular mail:
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec
H7L 4A8
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.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-
ei_form_e.html
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-
ei_guide-ldir_e.html
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Sincerely,
original signed by
Franca Mancino, M. Sc.
Senior Director, Regulatory Affairs &
Pharmacovigilance
sanofi-aventis Canada Inc.
-30-
/For further information: Health Canada: Marketed Health
Products
Directorate (MHPD), MHPD_DPSC@hc-sc.gc.ca, (613)
954-6522, Fax: (613)
952-7738/
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