Adverse Events
The adverse events of Vayarin® were evaluated in a randomized, double blind, placebo-controlled study of 15 weeks followed by an open label extension of an additional 15 weeks [38].
Adverse events reported during the course of the double-blind phase (table 2): 12 participants from the Vayarin® group and 5 participants from the placebo group were classified by the study physicians as suffering from treatment related, or probably related, adverse events (13 and 5 adverse events, respectively). There were no significant differences between the study groups in either the incidence or number of adverse events recorded (P = 0.848 and P = 0.982, respectively).
Adverse events reported during the course of the open-label extension (table 2): 5 participants reported 7 adverse events that were classified by the study physicians as related or probably related to the study treatment.
Table 2
| Study design | Double-blind study (4 capsules/day) | Open-label extension (2 capsules/day) | |
| Treatment Group Adverse event* | Vayarin®
(n=137) |
Placebo
(n=63) |
Vayarin®
(n=150) |
| Gastrointestinal discomfort | 6 | 4 | 4 |
| Atopic dermatitis | 1 | 0 | 0 |
| SGOT value | 1 | 0 | 0 |
| Headache | 0 | 1 | 1 |
| Insomnia | 0 | 0 | 1 |
| Tics | 1 | 0 | 0 |
| High triglycerides | 0 | 1 | 1 |
| Nausea | 1 | 0 | 0 |
| Hyperactivity | 1 | 0 | 0 |
| Tantrum | 2 | 0 | 0 |
Table 2. Adverse events reported during the course of the double-blind and the open label phase.
*Judged by the study physicians as related or probably related to the study treatment.
