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Table 3 Differences between NICE Guidelines and SPC Content

From: A systematic review of the safety information contained within the Summaries of Product Characteristics of medications licensed in the United Kingdom for Attention Deficit Hyperactivity Disorder. how does the safety prescribing advice compare with national guidance?

NICE Guideline Recommendation Conflict (emphasis in bold reflects SPC)
Warn of suicidal problems and self harming behaviour with atomoxetine Suicidal problems are a contraindication to the use of methylphenidate (omitted) Self-harm is not listed anywhere on the atomoxetine SPC Similar warnings are listed on SPCs for both atomoxetine and methylphenidate
Use MPH in adults Most forms of methylphenidate are unlicensed. Atomoxetine and all strengths of Concerta are licensed in adults who were prescribed atomoxetine/Concerta in childhood and who continue to demonstrate a favourable response
Use methylphenidate or atomoxetine when stimulant misuse or risk of stimulant diversion are present There are specific warnings on methylphenidate SPCs about risk of misuse, diversion and related issues. In high risk cases, the advice on methylphenidate SPCs is to use atomoxetine Atomoxetine has no warnings or precautions relating to drug misuse
In people with ADHD, heart rate and blood pressure should be monitored and recorded on a centile chart before and after each dose change and routinely every 3 months Atomoxetine and methylphenidate-Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months Dexamfetamine-Blood pressure should be monitored at appropriate intervals in all patients taking dexamfetamine, especially those with hypertension
In people taking methylphenidate, atomoxetine, or dexamfetamine: Growth and development should be monitored during treatment with atomoxetine
• height should be measured every 6 months in children and young people Methylphenidate-Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart
• weight should be measured 3 and 6 months after drug treatment has started and every 6 months thereafter in children, young people and adults Dexamfetamine-Height and weight should be carefully monitored in children as growth retardation may occur
In young people and adults, sexual dysfunction (i.e., erectile and ejaculatory dysfunction) and dysmenorrhoea should be monitored as potential side-effects of atomoxetine This warning is not contained within the SPC for atomoxetine. Clinical trial data in adults shows sexual dysfunction as an undesirable effect. Post-marketing surveillance data in children, adolescents and adults list priapism and male genital pain as an undesirable effect
Use methylphenidate or atomoxetine with tics/Tourette's In a controlled study of paediatric patients with ADHD and co morbid chronic motor tics or Tourette's Disorder, atomoxetine-treated patients did not experience worsening of tics compared to placebo-treated patients. There have been very rare post-marketing reports of tics in patients taking atomoxetine). Patients who are being treated for ADHD with atomoxetine should be monitored for the appearance or worsening of tics
  Methylphenidate is associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported. Family history should be assessed and clinical evaluation for tics or Tourette's syndrome in children should precede use of methylphenidate. Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate. Monitoring should be at every adjustment of dose and then at least every 6 months or every visit
Use methylphenidate or atomoxetine with anxiety disorder In two controlled studies (one in paediatric patients and one in adult patients) of patients with ADHD and co-morbid anxiety disorders, atomoxetine-treated patients did not experience worsening of anxiety compared to placebo-treated patients.
  There have been rare post-marketing reports of anxiety in patients taking atomoxetine. Patients who are being treated for ADHD with atomoxetine should be monitored for the appearance or worsening of anxiety symptoms.
  Methylphenidate is associated with the worsening of pre-existing anxiety, agitation or tension. Clinical evaluation for anxiety, agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening of these symptoms during treatment, at every adjustment of dose and then at least every 6 month or every visit
In particular, those treated with atomoxetine should be closely observed for agitation, irritability, suicidal thinking and self-harming behaviour, and unusual changes in behaviour, particularly during the initial months of treatment, or after a change in dose Atomoxetine SPC-Treatment emergent agitation in children and adolescents without a prior history of psychotic illness or mania can be caused by atomoxetine at usual doses. Irritability is a common adverse event but has no monitoring requirement specifically
  Methylphenidate SPCs-Psychiatric disorders to monitor for... include (but are not limited to)... agitation, irritability. Methylphenidate is associated with the worsening of... agitation or tension. Clinical evaluation for... agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening of these symptoms during treatment, at every adjustment of dose and then at least every 6 month or every visit. Irritability is a common adverse effect of methylphenidate and patients receiving long-term therapy should be monitored for this amongst other psychiatric adverse effects.
  Suicidal ideation is an uncommon side effect on both methylphenidate and atomoxetine SPCs. Self harm is not mentioned on either SPC
  1. ADHD: attention deficit hyperactivity disorder; MPH: methylphenidate; NICE: National Institute for Health and Clinical Excellence; SPC: Summary of Product Characteristics