for suicidal behaviour for children on ADHD drug, regulator warns
by staff reporter
health professionals have been urged to watch out for suicidal thoughts
and behaviour for children on the ADHD drug Strattera.
government's drugs regulator, the Medicines and Healthcare products
Regulatory Agency (MHRA), issued the warning after the drug's manufacturer,
Eli Lilly, submitted new clinical trial data showing an increased
risk of suicidal thoughts and behaviour in children on Strattera,
known also as atomoxetine.
MHRA's announcement on Strattera echoes a decision in 2003 when
it announced - years after the drugs were licensed - that SSRI anti-depressants
were linked with increased suicide-related behaviour in young people.
MHRA was criticised in April by a parliamentary health committee
for prioritising the interests of the pharmaceutical industry over
MHRA licensed Strattera for the UK in July 2004. Around 15,000 patients
have been treated with the drug in the past year, although Ritalin
is the main drug used on children diagnosed with the controversial
ADHD (attention-deficit hyperactivity disorder) diagnosis.
Eli Lilly data was from 12 clinical trials carried out in 1,357
children/adolescents. The trials compared the effects of Strattera
and placebo. Among those young people treated with Strattera, six
showed suicidal tendencies - one was a case of suicide attempt and
five had suicidal thoughts. The age range of children experiencing
suicidal behaviour or thoughts was seven to 12 years.
suicidal events occurred in the 851 patients receiving placebo.
June Raine, director of medicines post-licensing at the MHRA said:
"We are advising healthcare professionals that patients should
be carefully monitored for signs of depression, suicidal thoughts
or suicidal behaviour and referred for alternative treatment if
who are doing well on this medication should continue their treatment.
who experience any unusual symptoms, or are concerned, should speak
to their doctor to discuss the best course of action."
and healthcare professionals are urged to report any suspected adverse
reactions to Strattera via the Yellow Card Scheme.
February this year the MHRA also warned that Strattera may "very
rarely" be associated with liver disease.
MHRA question and answer document on Strattera (pdf)
5, 2005: Government refuses to independently publish data on psychiatric
drugs - despite health committee warning that drugs regulator
prioritises interests of pharmaceutical industry over public safety
11, 2005: Overhaul drugs regulatory system, MPs urge - the MHRA
criticised for prioritising the interests of the industry over public
7, 2005: ADHD drug can cause liver damage, drugs regulator warns
- Strattera may "very rarely" be associated with liver
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