Alternative Mental Health News- Article: Suicide Risk Leads to UK Antidepressant Ban for Children

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Article: Suicide Risk Leads to UK Antidepressant Ban for Childrenindex

The British government has taken action to ban the use of selective serotonin

reuptake inhibitors (SSRIs) in children and adolescents under the age of 18.

They did this on the basis of an independent review of the safety and efficacy

of the SSRI class in the treatment of children with major depression.

The review was undertaken by the Expert Working Group of the Committee on Safety

of Medicines (CSM). The CSM has advised that the balance of risks and benefits

for the treatment of major depressive disorder in those under 18 is unfavorable

for the sertraline (Zoloft), citalopram (Celexa) and escitalopram (Lexapro), in

addition to the previously- contraindicated paroxetine (Seroxat, Paxil) and

venlafaxine (Efexor).

British GPs have prescribed SSRIs for at least 50,000 children despite the fact

that none of the drugs has been licensed in the UK for use in children with

depression.

SSRIs are aggressively advertised and widely prescribed, despite reports of

suicides and withdrawal symptoms and the drugs' frequent failure to outperform

placebo in even company-controlled clinical trials. See The Emperor's New Drugs:

An Analysis of Antidepressant Medication,

http://journals.apa.org/prevention/volume5/pre0050023a.html.

GlaxoSmithKline issued a letter warning physicians in the UK -- but not in the

US -- about the hazards of Seroxat (Paxil) for children.

On Dec. 9, 2003, the UK's Medicines and Healthcare Products Regulatory Agency

(MHRA) told doctors not to prescribe all but one of the antidepressants known as

selective serotonin reuptake inhibitors (SSRIs). The exception is Prozac, which

is licensed for use in depressed children in the US. But the MHRA warning says

Prozac helps only one child in 10 at best. The Alliance for Human Research

Protection reports that Eli Lilly's new Prozac Fact Sheet sent to UK physicians

shortly after the UK ban -- but not to US physicians -- now states that Prozac

is not recommended for children for any indication.

Public unease about reported side effects prompted the agency to investigate

last year. It has looked at the details of clinical trials of depressed children

that were in the hands of the drug companies in the late 1990s. These studies

revealed the problem of suicidal behavior in children, but the companies did not

draw it to the attention of the regulators in the US or the UK.

It has become clear from the investigation that the regulators generally see

only a summary of the data resulting from trials. It is prepared for them by the

drug company only when it is seeking a license.

Trials on children have not been carried out in all the drugs, but the completed

studies show a worrying increase in suicidal behavior among those on SSRIs

compared with those given a placebo (sugar pill).

Seroxat, said to have been prescribed to up to 8,000 children by June 2003, was

banned after research showed it could trigger suicidal thoughts and thoughts of

self-harm. The drug's maker, GlaxoSmithKline, disagreed with the Government's

decision at the time, saying it would " limit the choices " available to doctors

to treat depression. The Government's SSRI review group now plans to review the

safety and efficacy of the drugs in adults.

The first major Seroxat trial in children was finished by 1996, but the results

were not published until 2001. Data was also gathered in 1996 after a trial of

Lustral, manufactured by Pfizer, showing that 9% of depressed children on the

drug became suicidal.

 

 

 

 

 

 

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