Atomoxetine associated with risk of suicidal behaviour, warns CSM
Atomoxetine (Strattera) has been associated with an increased risk of
suicidal thoughts or behaviour in children and adolescents, the Committee
on Safety of Medicines has warned.
In a letter to health professionals issued last week, the committee highlighted
new clinical trials data involving 1,357 children
and adolescents who were treated with atomoxetine for attention-deficit
hyperactivity disorder.
Suicide-related behaviour occurred in six of the patients treated with
atomoxetine (one suicide attempt, five cases of suicidal ideation). No
events were observed in the placebo groups
(n=851).
The CSM advises prescribers to monitor for signs of depression, suicidal
thoughts or behaviour and refer patients for appropriate treatment if
necessary. Patients with a history of depression or suicidal behaviour
may be at greater risk of suicidal thoughts or attempts and should be
monitored carefully. It specifies that patients and parents should be
informed of the risks and asked to be vigilant for clinical deterioration,
irritability or agitation, suicidal thoughts or behaviour or other unusual
changes in behaviour. “Children who are doing well on this medication
should continue their treatment,” said June Raine, director of
medicines post-licensing at
the Medicines and Healthcare products Regulatory Agency.
The CSM will investigate the available information on the risks and benefits
of atomoxetine and issue new guidance if necessary. Health care professionals
and patients are asked to report any suspected adverse drug reactions
via the yellow card scheme. Further details are available on the MHRA
website. |
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