Table 3.
Characteristics of psychiatric reports with hydroxychloroquine registered in VigiBase until December 2019
| Psychiatric adverse effectsa | Insomnia or sleep disorders | Anxiety | Depression | Psychotic disorders | Suicide or self-injury | Cognitive disturbances | |
|---|---|---|---|---|---|---|---|
| Number of reports | 751 | 237 | 166 | 148 | 104 | 92 | 74 |
| Reporting region | |||||||
| Americas | 484 (64.5) | 152 (64.1) | 116 (69.9) | 100 (67.6) | 52 (50.0) | 67 (72.8) | 41 (55.4) |
| Europe | 194 (25.8) | 47 (19.8) | 39 (23.5) | 45 (30.4) | 43 (41.4) | 22 (23.9) | 29 (39.2) |
| Othersb | 73 (9.7) | 38 (16.0) | 11 (6.6) | d | 9 (8.6) | d | d |
| Reporting year | |||||||
| 1983–1999 | 42 (5.6) | d | 9 (5.4) | 8 (5.4) | 13 (12.5) | d | 9 (12.2) |
| 2000–2009 | 73 (9.7) | 18 (7.6) | 18 (10.9) | 17 (11.5) | 11 (10.6) | d | 8 (10.8) |
| 2010–2019 | 635 (84.7) | 215 (90.7) | 139 (83.7) | 123 (83.1) | 80 (76.9) | 86 (93.5) | 57 (77.0) |
| Reporter | |||||||
| Physician | 312 (41.5) | 96 (40.5) | 65 (39.2) | 67 (45.3) | 47 (45.2) | 44 (47.8) | 32 (43.2) |
| Othersc | 340 (45.3) | 111 (46.8) | 80 (48.2) | 65 (43.9) | 37 (35.6) | 40 (43.5) | 29 (39.2) |
| Unknown | 99 (13.2) | 30 (12.7) | 21 (12.7) | 16 (10.8) | 20 (19.2) | 8 (8.7) | 13 (17.6) |
| Sex | |||||||
| Women | 617 (82.2) | 196 (82.7) | 145 (87.4) | 123 (83.1) | 86 (82.7) | 72 (78.3) | 63 (85.1) |
| Age at onset, years | |||||||
| Mean ± SD | 53.5 (16.0) | 55.0 (14.9) | 52.8 (15.0) | 55.2 (14.6) | 53.8 (17.4) | 49.4 (19.7) | 55.3 (17.5) |
| Time to onset, days | |||||||
| Median (IQR) | 5 (0–44) | 1 (0–8) | 5 (0–227) | 7 (0–36) | 7.5 (4–110) | d | 7 (5–83) |
| Serious | |||||||
| Yes | 443 (59.0) | 125 (52.7) | 90 (54.2) | 94 (63.5) | 68 (65.4) | 85 (92.4) | 47 (63.5) |
| Evolution | |||||||
| Death | 64 (8.5) | 0 | 1 | 1 | 0 | 48 (52.2) | 0 |
| Indications | |||||||
| Rheumatoid arthritis | 222 (29.6) | 89 (37.6) | 50 (30.1) | 53 (35.8) | 19 (18.3) | 5 (5.4) | 12 (16.2) |
| Other arthritis | 43 (5.7) | 15 (6.3) | 12 (7.2) | 7 (4.7) | 6 (5.8) | d | 7 (9.5) |
| Systemic lupus erythematosus | 41 (5.5) | 10 (4.2) | 7 (4.2) | d | 8 (7.7) | 6 (6.5) | 5 (6.8) |
| Other auto-immune diseases | 44 (5.9) | 14 (5.9) | 13 (7.8) | 8 (5.4) | 7 (6.7) | 6 (6.5) | 5 (6.8) |
| Other indications | 35 (4.7) | 6 (2.5) | 6 (3.6) | d | 11 (10.6) | 8 (8.7) | 5 (6.8) |
| Unknown | 366 (48.6) | 103 (43.5) | 78 (47.0) | 71 (48.0) | 53 (50.9) | 63 (68.5) | 40 (53.9) |
| Psychotropic drugs co-reported | |||||||
| Antidepressants | 148 (19.7) | 31 (13.1) | 34 (20.5) | 48 (32.4) | 25 (24.0) | 25 (27.2) | 23 (31.1) |
| Anxiolytics/hypnotics | 107 (14.3) | 25 (10.6) | 21 (12.7) | 32 (21.6) | 26 (25.0) | 26 (28.3) | 23 (31.1) |
| Antipsychotics | 43 (5.7) | 6 (2.5) | 8 (4.8) | 23 (15.5) | 21 (20.2) | 6 (6.5) | 18 (24.3) |
| Antiepileptics | 85 (11.3) | 29 (12.2) | 24 (8.4) | 29 (19.6) | 26 (25.0) | 11 (11.9) | 21 (28.4) |
Data are expressed as n (%) unless otherwise specified
SOC System Organ Class, MedDRA Medical Dictionary for Regulatory Activities, SMQs Standardized MedDRA® queries, SD standard deviation, IQR interquartile range
aPsychiatric adverse effects were selected using the terminology ‘Psychiatric disorders’ in the SOC view found in MedDRA®, or terms classified as ‘Depression and suicide/self-injury’ (broad) by the SMQs. Psychiatric adverse effects included the subgroups ‘Insomnia or sleep disorders’, ‘Anxiety’, ‘Depression’, ‘Psychotic disorders’, and ‘Cognitive disturbances’, including ‘Suicide or self-injury’. Each subgroup was not mutually exclusive
bOceania and Asia
cOther healthcare professionals and non-healthcare professionals (patient, pharmaceutical industry)
dInsufficient reports to calculate (fewer than five)