Drug linked to suicide

By MARTIN JOHNSTON health reporter

Despite overseas warnings about a popular anti-depressant's link to attempted suicide in youngsters, the Ministry of Health is not rushing to limit the drug's use by children and adolescents.

British Government advisers have said doctors should not treat people under 18 for depression with the drug paroxetine, sold in New Zealand under the brand name Aropax.

Their warnings are based on research on under-18s which found the drug was of no benefit in treating major depression but carried an increased risk of harmful side-effects.

In this country, the drug's maker, GlaxoSmithKline, has written to doctors advising them to consider gradually taking patients under 18 off Aropax. It has also posted warnings in the Aropax data sheet on a Ministry of Health website.

But the ministry has decided to take no immediate regulatory action.

"We will be reviewing all the data behind the British decision at the next meeting of the Medicines Adverse Reactions Committee on June 26 to determine whether the actions taken by GlaxoSmithKline are enough," said ministry spokesman Dr Stewart Jessamine.

About one-third of the people in New Zealand with serious depression take Aropax, including an estimated 500 children and teenagers under 18.

Glaxo says it has never promoted the drug's use for under-18s and it is not licensed for this age group, although doctors were permitted to prescribe it for them.

"There are no medications licensed in New Zealand for treatment of major depressive disease for adolescents or children," said Glaxo New Zealand's medical director, Dr Ian Griffiths.

The warning by Britain's Committee on Safety of Medicines is based on an analysis provided by Glaxo of previous studies involving more than 1000 people under 18.

Of the patients on the drug, 3.2 per cent experienced emotional "lability", which includes mood swings, suicidal thoughts and suicide attempts - more than twice the 1.5 per cent of those taking inert placebo pills who had these side-effects.

The suicidal thoughts and suicide attempts mainly occurred in adolescents with major depression.

Aropax, like Prozac, works by increasing the level of the chemical serotonin in the brain, which can help to alleviate the symptoms of depression. It is also used to treat some anxiety disorders.

British researchers now plan to check for any implications for adult users, but health authorities there said adults should not be frightened into giving up the drug.

Dr Griffiths said Glaxo could not recommend giving Aropax to under-18s, but parents concerned about children or adolescents taking it should take them to see their doctor rather than stop them using it.

Doctors should review the risks and benefits of continuing the drug and discuss future treatment options, including gradually withdrawing the drug.

The University of Otago-based Centre for Adverse Reactions Monitoring has received 256 reports of bad side-effects from Aropax since it was introduced in the early 1990s, ranging from headaches to suicide attempts.

Medical assessor Dr Michael Tatley said none of the five suicides or attempted suicides occurred in patients under 18. "The question is, to what extent is it truly due to the medication or to the underlying disease?"