Introduction 1 3 4 6 7 8 9 10 11 Methods Setting http://www.meldpuntmedicijnen.nl Report form The report form contained items which requested information on age, gender, type of medicine used, nature of the experience, a description of the experience and the relevance of the experience. Individuals filling in the report had to indicate whether the experience was related to either effectiveness, a side effect, a practical issue (e.g. difficulties with swallowing tablets) or a reimbursement issue. More than one experience related to the same drug could be submitted. Experiences related to effectiveness had to be further specified by the individual by selecting one of the following categories: ineffectiveness, a positive effect or a different type of effect (e.g. drug interactions). Experiences related to side effects had to be further specified by selecting one of the following categories: negative side effects, positive side effects (e.g. less side effects as compared with previous medication) or the absence of side effects. Relevance of the experience was assessed by asking the individual filling in the report to indicate both the impact of the experience on a 5-point scale (ranging from very negative to very positive) and whether the experience caused a change in antidepressant use. To specify the change in antidepressant use, those reporting had to select one of the following categories: discontinuation, switching to other treatment, adjustment of dosage or administration, any other action taken or no action taken. In the case of discontinuation of the antidepressant, the report also asked whether the HCP has been informed. Side effects 12 http://www.lareb.nl 13 Data analysis The relevance of the side effects was assessed by comparing the impact of the (grouped) side effects as a proportion of the side effects that were perceived as “very negative”. Relevance was also assessed by comparing the proportion of the side effects that caused discontinuation of initial antidepressant use, including the categories “discontinuation” and “switching to other treatment”. The impact and discontinuation proportions of the different groups of side effects were compared using the chi-square test. For the comparison between patients and HCPs, the groups of side effects were compared and expressed as an Odds Ratio (OR) and 95% confidence interval (CI). The 15 most frequently reported (groups of) side effects by patients as well as the 15 most frequently reported (groups of) side effects by HCPs were included in the analysis. Results Characteristics In total 2232 individuals submitted a report to the medicine reporting system during the study period, of whom 258 (12%) submitted a report on antidepressants. Of these 258 individuals, 248 (96%) reported for themselves and ten reported for a relative or acquaintance. The mean (±SD) age of the of the antidepressant users was 42.8 (±13.5) years and 72% were female. The majority of those reporting on antidepressants (63%) were reporting on a serotonin-reuptake inhibitor (SSRI); 12% were reporting on a tricyclic antidepressant (TCA) and 25% on another type of antidepressant. The antidepressants most frequently reported on were paroxetine (35% of total), venlafaxine (15%), citalopram (10%) and mirtazapine (8%). The use of a benzodiazepine as a concomitant drug was reported by 19% of those reporting on antidepressant use. Nature of experiences 1 Table 1 http://www.meldpuntmedicijnen.nl a Issue n Nature of issue Proportion individuals reporting on a specific issue Effectiveness n Ineffectiveness n Positive effect n Other n Side effects n Negative side effect n Positive side effect n Absence of side effect n Practical issues n   Reimbursement and availability issues n   a In total, 217 of the 258 individuals (84%) reporting on antidepressant use submitted a report on side effects. Of these, 202 (78%) described a total of 630 side effects that were experienced as negative. The number of reported side effects ranged from 1 to 11 per reporter experiencing a negative side effect. Twelve individuals (5%) reported that they had not experienced any side effect at all, and three (1%) submitted a positive experience with side effects, reporting that their current antidepressant therapy caused fewer side effects than their previous medication. Fourteen individuals (5%) reported a practical issue (such as problems with swallowing tablets or bad taste), and four (2%) reported a reimbursement or availability issue (receiving treatment for a relative short duration). 1 Relevance of side effects 2 Table 2 Relevance of the most frequently reported side effects related to antidepressant use Side effect n Impact (% perceived as “very negative”) Discontinuation of antidepressant use (%) Sleep disorder 68 47 50  Somnolence, drowsiness, fatigue 39 51 59  Insomnia, sleeplessness 29 41 38 Weight increase 48 46 56 Sexual problems 43 44 33 Discontinuation symptoms 40 43 50 Ineffectiveness 40 35 53 Apathy 28 46 54 Excessive sweating 23 43 39 Nausea, gagging 23 39 30 Dizziness, fainting 23 65 35 Headache 22 68 50 Dry mouth 18 50 61 a 9 78 78 a Of all side effects, 52% were perceived as “very negative”. The impact of the side effects differed almost significantly between the groups of side effects (p = 0.052), with headache, dizziness and fainting perceived as most negative. Side effects compared between patients and HCPs 3 Table 3 Reported side effects on antidepressants by patients compared with reported side effects on antidepressants by health care professionals (HCPs) Side effect Number of reported side effects by patients n Number of reported side effects by HCPs n a Top 15 most frequently reported side effects by patients   Weight increase 48 7.2 6 1.3 5.98 (2.54–14.09)   Sexual problems 43 6.4 6 1.3 5.31 (2.24–12.59)   Discontinuation symptoms 40 6.0 3 0.6 14.14 (4.35–45.93)   Ineffectiveness 40 6.0 3 0.6 14.14 (4.35–45.93)   Somnolence, drowsiness, fatigue 39 5.8 8 1.7 3.58 (1.66–7.73)   Insomnia, sleeplessness 29 4.3 4 0.8 5.28 (1.84–15.13)   Apathy 28 4.2 0 0 –   Excessive sweating 23 3.4 0 0 – b 23 3.4 8 1.7 2.05 (0.91–4.64) b 23 3.4 8 1.7 2.05 (0.91–4.64) b 22 3.3 11 2.3 1.42 (0.68–2.96)   Dry mouth 18 2.7 3 0.6 4.31 (1.26–14.71)   Abdominal pain 14 2.1 3 0.6 3.33 (0.95–11.65)   Anxiety 13 1.9 2 0.4 4.64 (1.04–20.66)   Depressed mood 11 1.6 3 0.6 2.60 (0.72–9.39) Top 15 most frequently reported side effects by HCPs   Rash, urticaria and pruritis 3 0.4 23 4.9 0.09 (0.03–0.29)   Laboratory abnormalities 0 0 22 4.7 –   Muscle and joint complaints 3 0.4 20 4.2 0.10 (0.03–0.34)   Congenital disorders 0 0 15 3.2 –   Eye and vision disorders 6 0.9 15 3.2 0.27 (0.11–0.71)   Paraesthesia 8 1.2 12 2.5 0.46 (0.19–1.14) b 22 3.3 11 2.3 1.42 (0.68–2.96)   Extrapyramidal disorders, Parkinsonism 1 0.1 10 2.1 0.07 (0.01–0.54)   Menstrual disorders, vaginal bleedings 3 0.4 10 2.1 0.21 (0.06–0.76)    Heart rhythm problems 7 1.0 10 2.1 0.49 (0.18–1.29)   Convulsions, epilepsy 0 0 9 1.9 –   Drug substitution problems 7 1.0 8 1.7 0.61 (0.22–1.70)   Serotonin syndrome 0 0 8 1.7 – b 23 3.4 8 1.7 2.06 (0.91–4.64) b 23 3.4 8 1.7 2.06 (0.91–4.64) 95% CI, 95% confidence interval a b Discussion 14 7 15 16 17 18 19 19 20 21