Side Effects of Zoom

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.