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What is Vayarin (phosphatidylserine-omega-3, Liprinen)?

Vayarin (phosphatidylserine-omega-3, Liprinen) is a prescription medical food for the clinical dietary management of complex lipid imbalances associated with childhood ADHD. 

Vayarin is a specially formulated and processed composition designed to address the distinct, medically determined lipid nutritional requirements of children with ADHD, the dietary management of which cannot be achieved by modification of the normal diet or use of dietary supplements. 

Common side effects of Vayarin include:

Vayarin has no listed serious side effects.

Drug interactions of Vayarin include some anticholinergic and cholinergic drugs. It should be used cautiously by people allergic to shellfish because it contains shellfish (krill). Safety and effectiveness of Vayarin in pregnant or breastfeeding patients have not been established. Therefore, Vayarin is not recommended for these populations.

What are the important side effects of Vayarin (phosphatidylserine-omega-3, Liprinen)?

WARNING

  • Vayarin should not be used by people who are allergic to any of its components.
  • It should be used cautiously by people allergic to shellfish because it contains shellfish (Krill).

Vayarin (phosphatidylserine-omega-3, Liprinen) side effects list for healthcare professionals

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.

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 designDouble-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 discomfort644
Atopic dermatitis100
SGOT value100
Headache011
Insomnia001
Tics100
High triglycerides011
Nausea100
Hyperactivity100
Tantrnm200

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

Drug Abuse

Vayarin does not have any known drug abuse or withdrawal effects.

What drugs interact with Vayarin (phosphatidylserine-omega-3, Liprinen)?

No information provided.

Summary

Vayarin (phosphatidylserine-omega-3, Liprinen) is a prescription medical food for the clinical dietary management of complex lipid imbalances associated with childhood ADHD. Vayarin is a specially formulated and processed composition designed to address the distinct, medically determined lipid nutritional requirements of children with ADHD, the dietary management of which cannot be achieved by modification of the normal diet or use of dietary supplements. Common side effects of Vayarin include abdominal pain, dry and itchy skin, tics, nausea, hyperactivity, tantrum, headache, and insomnia. There are no known serious side effects. It should be used cautiously by people allergic to shellfish because it contains shellfish (Krill).

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References
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Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.

38. Manor, I., et al., Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension. Eur Psychiatry, 2013. 28(6): p. 386-91.