Drug maker Eli Lilly issues warning about ADHD medication, Strattera
Canadian Press
September 29, 2005
TORONTO (CP) - Strattera, a drug used for treatment of attention-deficit hyperactivity disorder, will bear new warning labels cautioning that people taking the drug may experience suicidal thoughts, manufacturer Eli Lilly announced Thursday.
The new warnings were devised after discussions with Health Canada, which plans a review of all drugs used to treat the condition, a departmental spokesperson said. "Patients of all ages (on Strattera) should be closely monitored for signs of suicidal behaviour," Jirina Vlk said from Ottawa.
Vlk said Health Canada has asked all the makers of drugs used for ADHD to submit data from all clinical trials and post-marketing reports by the end of 2005. The data will be reviewed in the new year.
Drugs to be reviewed are Concerta, Adderall XR, Dexadrine, Ritalin and Attenade.
The Strattera warnings stem from the fact recent analysis of the combined trials of the drug showed a small number of people - five out of 1,357 - taking the drug experienced suicidal thoughts, while none of the 850 trial participants who received placebos reported suicidal thoughts.
The warning will appear both on the information given to patients and the material provided to doctors.
A release from Eli Lilly said that especially in the first weeks of treatment patients may feel worse rather than better, experiencing unusual sentiments such as aggression, hostility, anxiety, or have impulsive or disturbing thoughts involving self harm.
It warned users of the drug that they should not discontinue their medications should these thoughts occur, but should consult their doctors.
??The Canadian Press 2005
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