Strattera's Record of Taxpayer Subsidised Child Misery

Press Release 10 May 2010

Strattera, which is subsidised via the Pharmaceutical Benefits Scheme (PBS) as a second line treatment for ADHD, is possibly even more dangerous than ADHD amphetamines.  Strattera carries the highest possible black box warning for suicidal ideation, as well as a host of other warnings, including one for potentially fatal liver damage.(1)(2)

The appalling decision to put Strattera on the PBS, at an estimated cost of $101.2M over 4 years, was taken by former Health Minister Tony Abbott and the full Howard Cabinet in 2007.  Despite numerous approaches to Rudd Government Health Minister Nicola Roxon, and now Prime Minister Rudd, highlighting Strattera's horrid and completely avoidable record of misery inflicted on children, it remains on the PBS.

In total from when Strattera first came on the market in 2004, until 21 December 2009, there were 87 voluntary adverse event reports, including 39 involving suicidal or homicidal ideation or suicide attempts or self harm.(3)  It is impossible to know the true number of actual events as the voluntary nature of the reporting system means that only a tiny fraction the actual incidents get reported.(4)

Highlights of Adverse Drug Reactions Committee (ADRAC) adverse event reports for Atomoxetine Hydrochloride (Strattera)

• 11 year old boy who threw a cricket stump javelin style at a school teacher and threatened to kill himself.
• 8 year old boy who hit his head against a wall and had thoughts of suicide stating that he wants to kill himself.
• 8 year old male who suffered swollen, painful and tender testicles
• 25 year old woman who wanted to kill herself.
• 12 year old girl who experienced; anorexia, weight loss, fidgeting and compulsive behaviour that included ripping out fingernails and toenails, picking and cutting clothing, and anger outbursts.
• 7 year old girl who tried to kill herself and became very agitated while travelling in the family car and had explosive mood swings. She said that she intended to open the door and get out of the car, and she tried to open the car door.
• 9 year old boy who developed abnormal behaviour, including strange facial expressions with bilateral eyelid ptosis and became very emotionally withdrawn.
• 9 year old boy who displayed aggression, was totally irrational for three days and became violent, all of which was totally out of character.
• 11 year old boy who became agitated, emotionally labile and experienced thoughts of self-harm.
• 13 year old boy who experienced chest pains and hostile and aggressive behaviour, but the problems immediately disappeared with the cessation of Strattera.
• 9 year old boy who slammed his head against walls, had extreme mood swings, violent outbursts and was always angry, depressed or sad and said he wanted to kill himself.
• 10 year old boy who experienced nausea, then became acutely depressed, aggressive and had suicidal thoughts.
• 22 year old man who experienced suicidal and homicidal ideation
• 7 year old girl who experienced abdominal pain , nausea, severe right sided headache, shooting pains, white spots in visual fields, academic regression and faecal and urinary incontinence.
• 7 year old boy who experienced suicidal ideation and mood changes and suffered from increased aggression and threats to self with knife, picking his skin, poking self with knife
• 12 year old boy experienced very strong suicidal ideation...talking about dead bodies and about hanging himself
• 11 year old boy who attempted suicide and who experienced headache(s), stomach cramps, muscle rigidity and poor concentration.
• 7 year old boy who experienced suicidal ideation
• 10 year old boy who developed psychotic symptoms and talking about suicide.
• 11 year old boy who experienced a psychotic episode and took an overdose of his mother's thyroxine.
• 9 year old boy who experienced suicidal thoughts
• 11 year old boy who became extremely agitated and talked about wanting to die
• 13 year old boy who experienced suicidal ideation, physical and verbal aggression to family and became angry, withdrawn, socially isolatory, impulsive, moody
• 15 year old boy who was expressing suicidal thoughts
• 11 year old boy who took Strattera for the treatment of ADHD to complement Ritalin, under the influence of which he became suicidal and depressed.
• 12 year old girl who ripped out her fingernails and toenails.
• 9 year old girl who experienced self-harming
• 9 year old boy who expressed suicidal ideation, aggression and self harm and made drawings of him hanging upside down from tree, in (the) ocean
• 10 year old boy who was psychotic and experienced auditory hallucinations including "hearing voices in his head to kill his sister".
• 8 year old boy who lost his appetite and experienced homicidal ideation, lost weight and was angry and confused
• 15 year old girl who experienced suicidal ideation and started cutting herself to the extent that was life threatening.
• another 15 year old girl who experienced suicidal ideation and started cutting herself with razors, scissors and knives.
• 10 year old boy who experienced suicidal ideation.
• another 10 year old boy who had abnormal thoughts about others jumping off buildings.
• and an 8 year old boy who talked about killing himself in a boastful manner.

 Strattera on the PBS

In December 2006 the Commonwealth Government's Pharmaceutical Board Advisory Committee (PBAC) advised Eli Lily that Strattera had been recommended for inclusion on the PBS.(5)  Normally the final decision to approve a drug for inclusion on the PBS is a ministerial decision, however, because of the enormous cost involved, ($101.2M over 4 years), approval of the full Howard Government cabinet was required. Approval was granted in April and Strattera was placed on the PBS on 1 July 2007.  Eli Lilly had applied unsuccessfully on at least three previous occasions to have Strattera subsidised via the PBS.

In November 2008 Martin Whitely requested, via a Freedom of Information application, copies of all documents relating to the decision of the PBAC to recommend Strattera's listing on the PBS.  Martin was particularly interested in what consideration had been given by the PBAC to Strattera's black box warning for suicidal ideation and the numerous adverse event reports.  The Department of Health and Ageing refused to release all but a tiny percentage of heavily censored documents.  The Administrative Appeals Tribunal heard Martin's appeal against the department's decision to continue to hide these documents on 15 April 2010.  A decision on whether the public are entitled to see the evidence the PBAC used to recommend subsidising Strattera is pending.  However, when giving evidence on behalf of the PBAC, Ms Diana MacDonell, Director of the PBAC Secretariat Section, and Secretary of the PBAC, revealed the PBAC did not consider the 23 adverse events including 8 of suicidality that had been submitted to the TGA at that stage.

The election of the Rudd Government in November 2007 led to a false hope that the decision may be reversed and the $101.2M redirected to interventions that would help and not harm children.  Martin Whitely wrote to Rudd Government Health Minister Nicola Roxon in June 2008 highlighting Strattera's trail of misery and requesting it be removed from the PBS.  In response he received a letter from Minister Roxon's Parliamentary Secretary Jan McLucas, defending the process by which the decision to subsidise Strattera was made.

The Rudd government has effectively accepted responsibility for the Howard government's poor decision.  How much misery and suffering will children have to endure before Strattera is taken off the Pharmaceutical Benefits Scheme and preferably the market totally?  The known risks, including suicidality and liver failure, as demonstrated by actual incidents of nine year old boys attempting suicide and twelve year old girls ripping their fingernails and toenails out, surely swamp any temporary improvements in attentiveness and impulsivity.  Tony Abbot never should have allowed Strattera to be subsidised via the PBS.  Nicola Roxon has similarly failed to protect the welfare of Australia children.  Martin Whitely wrote to Prime Minister Kevin Rudd in February 2010 requesting that he intervene and immediately remove Strattera from the PBS and redirect resources to strategies that help, not harm, Australian children.

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[1] On September 29, 2005 the FDA issued a public health advisory announcing they had put the highest possible black box warning on Strattera for suicidal ideation. The advisory stated the "Strattera increases the risk of suicidal thinking in children and adolescents with ADHD...Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviours, or unusual changes in behaviour. Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviours with the prescriber." US Food and Drug Administration, Public Health Advisory: Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine), 29 September 2005. http://www.fda.gov./Drugs/DrugSafety/PublicHealthAdvisories/ucm051733.htm (accessed 13 September 2009)   Six months later (on March 19 2006) the Australian Therapeutic Goods Administration put a boxed warning for suicidal ideation on the Product Information made available to prescribers. The TGA did not issue a press release or take any action to ensure parents were informed that Strattera might make their children want to end their life. 

[2] On December 17, 2004 the U.S. FDA issued a talk paper, titled New Warning for Strattera, which stated, "The labelling is being updated with a bolded warning about the potential for severe liver injury……The labelling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labelling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events."  World Health Organisation, "Atomoxatine and liver injury, Drug Information, Vol. 19, No 2, (2005) http://apps.who.int/medicinedocs/en/d/Js7917e/2.22.html#Js7917e.2.22 (accessed 23 September 2006)

[3] Adverse events information related to Strattera obtained from the Therapeutic Goods Administration's Public Case Detail reports.

[4] A 2008 study by Curtin University pharmacologist Con Berbatsis identified that, because reporting is voluntary, only a tiny fraction (for GP's only 2%) of adverse events are reported.Con Berbatis, 'Primary care and Pharmacy: 4. Large contributions to national adverse reaction reporting by pharmacists in Australia', i2P E-Magazine, Issue 72: June 2008: p

[5] Julie Robotham, 'New drug can make children suicidal', The Sydney Morning Herald, 8 December 2006: p1