Table 2.
Clinical complications due to pregabalin reported in spontaneous reports (SRs) from 2010 to 2019.
| All pregabalin exposures | (%) | Pregabalin-only | (%) | Pregabalin in co-consumption | (%) | Co-consumed reported substances (n) | |
|---|---|---|---|---|---|---|---|
| Number of patients | 258 | 73 | 185 | ||||
| Number of patients with reported clinical complications | 125 | 48.4% | 19 | 26.0% | 106 | 57.3% | |
| Neurological complications | 102 | 81.6% | 16 | 84.2% | 86 | 81.1% | |
| Impaired consciousness (out of clinical “triad” of opioid overdose*) | 68 | 66.7% | 11 | 68.8% | 57 | 66.3% | Benzodiazepine (33); Opioids (17); Psychostimulants (19); Alcohol (18); Other psychotropic drugs (15); Cannabis (14) |
| Incl. Coma (GSC < 9) | 12 | 11.8% | 0 | 12 | 14.0% | Benzodiazepine (10); Other psychotropic drugs (6); Opioids (5); Psychostimulants (5); Alcohol (5); Cannabis (3) | |
| Psychomotor retardation - Dizziness - Ataxia | 19 | 18.6% | 5 | 31.3% | 14 | 16.3% | Opioids (5); Cannabis (5); Benzodiazepine (4); Psychostimulants (3); Alcohol (3); Other psychotropic drugs (2) |
| Involuntary/abnormal movements (dyskinesia, tremor, nystagmus, chorea) | 8 | 7.8% | 0 | 8 | 9.3% | Cannabis (3); Alcohol (3); Benzodiazepine (2); Opioids (2); Psychostimulants (2); Other psychotropic drugs (2) | |
| Convulsion | 7 | 6.9% | 1 | 6.3% | 6 | 7.0% | Opioids (3); Psychostimulants (3); Other psychotropic drugs (3); Alcohol (3); Benzodiazepine (2); Cannabis (2) |
| Miosis (out of clinical ‘triad’ of opioid overdose) | 10 | 9.8% | 0 | 10 | 11.6% | Cannabis (6); Benzodiazepine (5); Psychostimulants (4); Other psychotropic drugs (4); Alcohol (4); Opioids (3) | |
| Mydriasis | 7 | 6.9% | 1 | 6.3% | 6 | 7.0% | Alcohol (4); Psychostimulants (3); Cannabis (3); Benzodiazepine (2); Opioids (2) |
| Psychiatric complications | 43 | 34.4% | 5 | 26.3% | 38 | 35.8% | |
| Behavioral issues (agitation, aggressiveness, impulsiveness, disinhibition) | 27 | 62.8% | 3 | 60.0% | 24 | 63.2% | Benzodiazepine (11); Psychostimulants (8); Cannabis (8); Opioids (7); Alcohol (5); Other psychotropic drugs (4) |
| Depressed mood, dysthymia | 7 | 16.3% | 1 | 20.0% | 6 | 15.8% | Benzodiazepine (4); Psychostimulants (3); Alcohol (2); Opioids (2); Other psychotropic drugs (1) |
| Psychotic symptoms (delirium, hallucinations) | 6 | 14.0% | 0 | 6 | 15.8% | Opioids (2); Alcohol (2); Cannabis (2); Psychostimulants (1); Other psychotropic drugs (1); Benzodiazepine (1) | |
| Anxiety | 4 | 9.3% | 1 | 20.0% | 3 | 7.9% | Psychostimulants (2); Benzodiazepine (1); Cannabis (1); Other psychotropic drugs (1) |
| Euphoria | 2 | 4.7% | 1 | 20.0% | 1 | 2.6% | Opioids (1) |
| Clinical presentation of opioid overdose* (uncounted elsewhere) | 11 | 8.8% | 0 | 11 | 10.4% | Benzodiazepine (8); Opioids (8); Psychostimulants (7); Cannabis (6); Other psychotropic drugs (2); Alcohol (1) | |
| Respiratory complications | 4 | 3.2% | 0 | 4 | 3.8% | ||
| Dyspnea (out of clinical ‘triad’ of opioid overdose) | 4 | 100.0% | 0 | 4 | 100.0% | Opioids (3); Psychostimulants (2); Benzodiazepine (1); Cannabis (1); Other psychotropic drugs (1) | |
| Cardiac complications | 2 | 1.6% | 1 | 5.3% | 1 | 0.9% | |
| Atrioventricular block | 1 | 50.0% | 1 | 100.0% | 0 | ||
| Hypertrophic cardiomyopathy | 1 | 50.0% | 0 | 1 | 100.0% | Benzodiazepine (1); Cannabis (1) | |
| Others | 3 | 2.4% | 1 | 5.3% | 2 | 1.9% | |
| Hyperglycemia | 1 | 33.3% | 0 | 1 | 50.0% | Opioids (1); Psychostimulants (1); Cannabis (1); Alcohol (1) | |
| Hypoglycemia | 2 | 66.7% | 1 | 1 | 50.0% | Benzodiazepine (1); Psychostimulants (1); Cannabis (1) |
*
impaired consciousness and myosis and bradypnea. Bold values are indicates in main titles. Italic values are indicated in sub-category (among impaired consciousness there was cases of coma).