Review of prescribing SSRI antidepressants

Review of prescribing SSRI antidepressants to young people

In response to international concerns, the Medicines Adverse Reactions Committee (MARC) has completed a review of the safety and efficacy of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants when used to treat children under 18 with depression.

Ministry of Health spokesperson Dr Stewart Jessamine said "The committee examined a number of reports and research papers, including data indicating that treatment options for children with depression are limited, as the other main group of antidepressant medications available, the tricyclic antidepressants, have marginal efficacy and poor safety in the under-18 age group."

"The MARC concluded that as a result of the small number of studies reported, the limited number of patients included in each study and inconsistencies in how each study defined safety and efficacy, an accurate determination of the risks and benefits of SSRI's as treatments for children under 18 with depression cannot be made at this point."

Dr Jessamine said "The committee acknowledged that, with the support of specialist advice, SSRIs could continue to be used as they may help in the management of depression in some children under 18 years."

”In issuing this advice, the MARC particularly wants to reinforce the message that SSRI antidepressants should not be stopped suddenly, as this can cause worsening of the symptoms of depression. Parents of children who are taking these medications should talk to their doctor before stopping or changing treatments,” Dr Stewart Jessamine says.

“The committee has placed a high priority on reviewing the safety of SSRIs as more data becomes available, and Medsafe understands that a report commissioned by the United States Food and Drug Administration will provide further data on the safety of the SSRI antidepressants later this year.”

In the interim, Medsafe has sent a letter containing the MARC advice to doctors and pharmacies to help them discuss the treatment options, for children with depression, with patients and their families.

Full prescribing information for the SSRI antidepressants can be found under the brand name of each medication in the data sheets section of the Medsafe web site (www.medsafe.govt.nz).

Background

The SSRI medicines available in New Zealand are:

• Citalopram (brand names: Cipramil, Celapram) • Escitalopram (brand name: Lexapro) • Fluoxetine (brand names: Fluox, Prozac) • Fluvoxamine (brand name: Luvox) • Paroxetine (brand name: Aropax) • Sertraline ((brand name: Zoloft) • Venlafaxine (brand name: Efexor)

In New Zealand, none of the SSRIs have ever been approved for use in the treatment of depression in children aged less than 18 years (however, it is known that off-label use occurs in this age group). NZ data sheets (information provided for medicine prescribers) for all SSRIs state for depression that "Safety and effectiveness in children has not been established". All but fluoxetine and sertraline go further to state at least that "use is not recommended in children". Data sheets are available on the Medsafe web site www.medsafe.govt.nz.

In June 2003, the UK Committee on Safety of Medicines issued a letter to UK prescribers advising against the use of paroxetine as therapy for children and adolescents with depressive illness. This advice was based on new data from GlaxoSmithKline (GSK)-sponsored clinical trials of Aropax in paediatric patients. At this time, the New Zealand data sheet for paroxetine (Aropax) was updated to advise that clinical trials do not support the use of paroxetine in the treatment of children with major depressive disorder (MDD). In addition, GlaxoSmithKline issued a related Dear Doctor letter to New Zealand prescribers.

In June 2003, Medsafe and the Medicines Adverse Reactions Committee (MARC; an independent expert advisory committee to the Minister of Health) reviewed the 'Technical document summaries - Summary of clinical safety data' for paroxetine provided to Medsafe by GSK. The Committee agreed that the data were not of sufficient quality to justify any additional regulatory action (beyond that already taken by GSK) regarding the use of paroxetine at that time. The decision was made to keep a watching brief on this issue.

In August 2003, Wyeth updated the New Zealand data sheet for venlafaxine (Effexor) to advise against prescribing venlafaxine as therapy for children and adolescents with depressive illness. This was based on data from paediatric trials, which showed increased reports of suicide-related adverse events in paediatric patients receiving venlafaxine treatment for MDD. In addition, Wyeth issued a related Dear Doctor letter to New Zealand prescribers.

During its preliminary evaluation, the MARC reviewed reports from the UK Committee on Safety of Medicines, the American College of Neuropsychopharmacology, US Food and Drug Administration (FDA) advisory committees, and the Royal Australasian and New Zealand College Psychiatrists.

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