Watch out for suicidal behaviour for children on ADHD drug, regulator warns

October 5, 2005
by staff reporter

Mental health professionals have been urged to watch out for suicidal thoughts and behaviour for children on the ADHD drug Strattera.

The 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.

The 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.

The MHRA was criticised in April by a parliamentary health committee for prioritising the interests of the pharmaceutical industry over public safety.

The 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.

The 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.

No suicidal events occurred in the 851 patients receiving placebo.

Dr 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 necessary.

"Children who are doing well on this medication should continue their treatment.

"Those who experience any unusual symptoms, or are concerned, should speak to their doctor to discuss the best course of action."

Patients and healthcare professionals are urged to report any suspected adverse reactions to Strattera via the Yellow Card Scheme.

In 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)

See also:
Sept 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
April 11, 2005: Overhaul drugs regulatory system, MPs urge - the MHRA criticised for prioritising the interests of the industry over public safety.
Feb 7, 2005: ADHD drug can cause liver damage, drugs regulator warns - Strattera may "very rarely" be associated with liver disease.

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