We should never forget that the Product Information (PI) of medicines tell us about the experiences of real people, but in an impersonal way.

The atomoxetine (Strattera®) PI has a boxed warning that 0.4% of children (≤12 years) had suicidal thoughts during short-term placebo controlled studies, and the latest Medicines Safety Update advises us that 42 adverse event reports about atomoxetine were related to suicidal ideation, most patients being aged 18 and younger.

Of the four medicines approved by the PBS for the treatment of ADHD, the Database of Adverse Event Notifications shows that atomoxetine has the highest risk of suicidal thoughts, particularly if we can assume that the relative consumption levels of these medicines are aligned to the quantities supplied under the PBS (see table below).

Relativity of Adverse Events for ADHD Medicines

Medicine Suicidal Ideation (Completed) Total Adverse Events Reported Annual PBS/RPBS Supplies
Atomoxetine 42 (1) 118 (2004-2006) 29,600
Dexamphetamine 2 (0) 79 (1981-2013) 132,000
Modafinil 2 (0) 19 (2003-2012) 4,600
Methylphenidate 8 (1) 265 (1980-2013) 363,000

Patients should always be educated about what to look out for in medicines they are taking, and any problems identified with medicines, vaccines or medical devices should be reported to the TGA.

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