Reference | Study type | Subject numbers | Results/comments |
---|---|---|---|
27 | Retrospective cohort studies using Canadian and UK health databases | 7195 users of isotretinoin | Prevalence rates of neurotic and psychotic disorders, suicide and attempted suicide were compared between isotretinoin and antibiotic users and within isotretinoin users (pre- and post-treatment). No increased risk of depression, suicide or suicidal ideation |
13700 users of antibiotics (Canada) | |||
340 users of isotretinoin | |||
676 users of antibiotics (UK) | |||
29 | Retrospective prescription sequence symmetry analysis | 2821 users of isotretinoin in a US pharmacy database | Patients treated with both isotretinoin and antidepressant. Adjusted ratios (of numbers of patients filling isotretinoin. prescriptions first versus numbers filling antidepressant prescriptions first) was not significantly greater than 1.0 |
20 | Statistical data mining analysis | Of all adverse effects and drug combinations in FDA's AERS database | Six suicides could be expected in patients taking isotretinoin compared to the 36 suicides observed |
30 | Prospective, uncontrolled study | 189 patients commenced on isotretinoin and treated for 4 months | 4% reported depression—by self-report in response to questionnaire item at clinical reviews. No objective ascertainment of depression |
31 | Prospective, uncontrolled study | 92 patients commenced on isotretinoin and treated for 16 weeks | 11% reported depression—by self-report at clinical review. No objective ascertainment of depression |
32 | Prospective, uncontrolled study | 88 patients treated with isotretinoin, followed annually for 10 years | ‘No long-term clinical side effects were identified in any of the patients.’ It is not reported whether evidence of depression or other psychiatric symptoms were specifically sought |
33 | Prospective, uncontrolled study | 720 patients treated with one or more courses of tretinoin | Patients followed up for 2–10 years. Asked at each follow-up visit (4–6 months) re symptoms—not specifically asked about psychiatric symptoms. Three subjects reported persistent depression |
34 | Prospective, uncontrolled study | 466 patients treated with isotretinoin, observed through a 4–5 month course | No depression or other psychiatric effects recorded—but depression and psychiatric morbidity seemingly not specifically sought |
35 (Study 1) | Prospective, uncontrolled study | 67 patients receiving isotretinoin for 16–20 weeks | No psychiatric side effects in any subjects. Study incompletely reported |
35 (Study 2) | Prospective, uncontrolled study | 300 patients receiving isotretinoin for 20 weeks | 0.3% of subjects reported psychiatric adverse events (nature not specified). Study incompletely reported |
An extended version of this table can be found at http://www.rcgp.org.uk/journal/index.asp.