Australia: Children's Drug Linked to Suicide

December 25, 2006

Australia figures it out...

Children's drug linked to suicide.

Robotham Medical Editor

December 8, 2006

SERIOUS psychiatric side-effects have emerged in children as young as seven

who take a new drug for behaviour problems that will be available widely

under the Pharmaceutical Benefits Scheme.

The drug, Strattera, was the probable cause of one child's explosive mood

swings and erratic behaviour, including an attempt to open the door of a

moving car, according to an assessment by the Federal Government's

Therapeutic Goods Administration.

It also implicated the drug in aggressive outbursts by a 12-year-old, in

which she ripped out her fingernails.

The TGA has identified 23 cases of probable or possible side-effects from

Strattera, which is used to treat attention deficit hyperactivity disorder

(ADHD). They include suicidal thoughts, agitation, and serious physical

problems such as growth retardation, weight loss, chest pains and swollen

testicles.

The medicine is marketed by the drug giant Eli Lilly as the only

non-stimulant alternative to the usual therapies, methylphenidate - known as

Ritalin - and dexamphetamine. Both are stimulants that can improve

concentration but may cause insomnia and weight loss, and can be traded and

abused.

Strattera works by regulating levels of the neurotransmitter chemical

norepinephrine in the brain. It is used by children and adolescents who

cannot tolerate stimulants or have conditions such as anxiety in addition to

ADHD - which is thought to affect 3 to 5 per cent of children. Only about 1

per cent of children receive drug treatment for the disorder.

A spokesman for Eli Lilly, de Leon, said yesterday the company had been

informed Strattera would be added to the PBS, reducing its price from more

than $140 at present for a month's supply to $29.50, or $4.70 for those

receiving a concession.

About 2000 Australians had taken Strattera, 1400 of them children, since its

launch in 2004, Mr de Leon said. After a PBS listing, there is usually a

surge in the number of people who are prescribed a drug, which they could

not previously afford.

After new links between Strattera and thoughts of self-harm first emerged

last year in the US, the company wrote to doctors and pharmacists to alert

them to possible reactions, Mr de Leon said. It had also upgraded the

official warning included with its product information, at the request of

the TGA.

But he said untreated ADHD could also damage children's health, because

their uncontrolled behaviour meant they had a higher chance of being injured

and abusing alcohol or drugs.

The head of psychological medicine at Adelaide's Women's and Children's

Hospital, Jon Jureidini, said the side-effects " highlight the need for

caution when prescribing drugs that affect the brain … they're the kind of

side-effects you'd expect from a drug that is a cousin " of antidepressants

such as Aropax and Efexor, which the TGA says should not be used by children

because they can trigger suicidal impulses.

Philip Hazell, director of the Child and Adolescent Mental Health Service

within the Sydney South West Area Health Service, said it was a concern that

in formal trials of Strattera the psychological side-effects occurred mainly

in younger children. Serious reactions appeared to be rare, said Professor

Hazell, who has consulted to Eli Lilly on its advisory board.

Florence Levy, an ADHD specialist and conjoint professor at the University

of NSW and Prince of Wales Hospital, said she prescribed Strattera at lower

than the recommended dose, monitoring the child's response before

considering an increase.

December 25, 2006