Vayarin (phosphatidylserine-omega-3, Liprinen) Side Effects, Warnings, and Drug Interactions

• What is Vayarin (phosphatidylserine-omega-3, Liprinen)?
• What are the important side effects of Vayarin (phosphatidylserine-omega-3, Liprinen)?
• Vayarin (phosphatidylserine-omega-3, Liprinen) side effects list for healthcare professionals
• What drugs interact with Vayarin (phosphatidylserine-omega-3, Liprinen)?

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:

• abdominal pain,
• dry and itchy skin,
• tics,
• nausea,
• hyperactivity,
• tantrum,
• headache, and
• insomnia.

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.

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 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 Tantrnm 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

Drug Abuse

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

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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Related Disease Conditions

• Omega-3 Fatty Acids Omega-3 fatty acids are essential nutrients that play a crucial role in supporting heart health and overall well-being. Foods rich in omega-3 fatty acids include certain types of fish, walnuts, vegetable oils, and more. Researchers believe that a diet rich in omega-3 fatty acids can improve cholesterol levels and reduce the risk of coronary heart disease.
• Adult ADHD (Attention Deficit Hyperactivity Disorder) About 2%-6% of adults have ADHD, a common behavioral problem. Symptoms include impulsivity, hyperactivity, and inattention. Treatment may involve ADHD education, attending a support group, skills training, and medication.
• ADHD in Children Attention deficit hyperactivity disorder (ADHD) causes the following symptoms in children: excessive activity, problems concentrating, and difficulty controlling impulses. Stimulant medications are the most common medication used to treat ADHD.
• ADHD in Teens Attention deficit hyperactivity disorder (ADHD) in teens is a disruption of neurocognitive functioning. Genetics contribute to ADHD. Symptoms of ADHD in teens include inattention, hyperactivity/impulsivity, or a combination of these. Treatment may include cognitive behavioral therapy, behavior therapy, medication, or alternative therapies.
• Parenting a Child With ADHD ADHD is a behavioral condition with characteristics that include hyperactivity, inattention, and impulsivity. Parenting a child with ADHD presents a variety of challenges. Treatment options for children with ADHD include medication and behavioral therapy.

Treatment & Diagnosis

Medications & Supplements

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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.