Family call for black box warning on Prozac

The family of a 14-year-old Dublin boy who took his own life six weeks after being prescribed Prozac is calling on the health minister to place a “black box” warning on the drug, like in the US.

The family has also lodged a complaint with the Medical Council. The complaint highlights a lack of literature and information given to them about Prozac.

Jake McGill-Lynch took his own life in 2013. His inquest earlier this year returned an open verdict and not one of suicide after an email emerged where he said he felt “drugged”. Jake was prescribed Prozac, an SSRI anti-depressant, after expressing anxiety about his forthcoming exams.

Stephanie McGill-Lynch, Jake’s mother, said Jake had previously been diagnosed with Asperger’s syndrome, but had never been given a diagnosis of depression.

“What happened to Jake was completely preventable. He was never diagnosed with depression but was given a drug because he said he was worried about his mock Junior Cert. What kid isn’t? Asperger’s is not a condition that can be treated with an anti-depressant, nor should it be.”

Ms McGill-Lynch said no-one is listening to her family, or willing to recognise the adverse side effects that prescription mental health drugs can cause.

In 2004, US medicines watchdog the FDA added a black-box warning to SSRI anti-depressants on the increased risk of suicide among children taking these drugs. A spokesperson for the Irish counterpart, the HPRA, said Ireland does not use black-box warnings, but Prozac’s leaflet information gives the same warnings as in the US.

The product information for Prozac states: “Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.”

Further it says Prozac “should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other conditions”. And then only in conjunction with counselling.

If a decision to prescribe the drug is taken, the patient should be carefully monitored, the HPRA said. In Jake’s case he did not have a diagnosis of depression, his mother said, nor was he monitored or given counselling during the time he was on the drug, in fact his condition deteriorated.

A 2015 Irish paper by the Royal College of Surgeons on the use of anti-depressants in children found that the use of fluoxetine (Prozac) increased from 2002 to 2011.

During a recent reanalysis of a controversial clinical trial, Study 329, researchers found paroxetine — touted in 2001 as safe and effective for teenagers — was neither.

Dr David Healy, one of the authors of the re-analysis, said adverse events in the original study involved suicidal thinking or behaviour, but were labelled as something else.

In 2012, Dr Healy and retired assistant state pathologist, Dr Declan Gilsenan, met with Minister with responsibility for Mental Health, Kathleen Lynch, to warn her about the dangers of SSRIs.

Dr Healy told the minister that drug-induced death is likely the biggest killer within the field of mental health. Dr Gilsenan said he’d like to see all suicide verdicts from coroners investigated to see what medications people were on at the time of their deaths.

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