Posted by catachrest on October 3, 2005, at 9:38:01
From the Health Canada Web site:
This is duplicated text of a letter from Eli Lilly Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information
on Strattera (atomoxetine hydrochloride)Subject: Health Canada advises Canadians of new warning for STRATTERATM (atomoxetine hydrochloride)
TORONTO, Ontario - September 29, 2005 - Eli Lilly Canada Inc., following discussions with Health Canada is advising Canadians that Strattera™ (atomoxetine hydrochloride) will now carry a new warning. This new warning indicates that patients of all ages taking Strattera may experience behavioural and/or emotional changes that put them at increased risk of self harm.
The new warning for Strattera will appear in the information package received by patients and in the prescribing information available to health professionals.
Patients, their families and caregivers should note that a small number of patients taking Strattera may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of aggression, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self harm.
Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. Treatment with Attention-Deficit/Hyperactivity Disorder (ADHD) medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.
Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.
This advisory stems from a recent analysis of placebo-controlled studies with Strattera. The analysis showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with Strattera (5/1357 [0.37%]) compared to those treated with placebo (0/851).
Strattera is a selective norepinephrine reuptake inhibitor, indicated only for the treatment of Attention-Deficit Hyperactivity Disorder in children six years of age or older, adolescents and adults.
CUSTOMER AND HEALTHCARE PROFESSIONAL INQUIRIES:
Eli Lilly Canada's Customer Response Centre 1-888-545-5972 (8:00 a.m. to 6:00 p.m. ET)MEDIA INQUIRIES, PLEASE CONTACT:
Stephanie Batcules
Eli Lilly Canada Inc.
(416) 693-3571Strattera™ is a registered trademark of Eli Lilly and Company, used under license.
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario M1N 2E8
Canada
Tel.: 1-888-545-5972
Fax: 1-888-898-2961Any 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.caFor other inquiries, please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
E-mail: bcans_enquiries@hc-sc.gc.ca
Tel.: (613) 941-1499
Fax: (613) 941-1668The 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/advisories-avis/public/index_e.html
poster:catachrest
thread:562261
URL: http://www.dr-bob.org/babble/20051003/msgs/562261.html