Vayarin is a food available by prescription only, for the purpose of treating ADHD. The principal ingredient of Vayarin is phosphatidylserine omega 3 enriched with EPA (an omega 3 fatty acid). It also contains a small amount of DHA (another omega 3 fatty acid). The nearest nonprescription source of these components is fish oil, which does not contain phosphatidylserine. Vayarin is registered with the FDA as a medical food, not a drug, which means that it does not have to undergo the same rigorous clinical trial process of approval that medications do to show that it is safe and effective for the treatment of ADHD.
Is it effective?
There is only one study supporting Vayarin's effectiveness. It included 200 children, which is a good sized trial for a nonmedicinal treatment, but it would not have been large enough to support FDA approval of Vayarin as a drug. Also, at least some of the study's authors were employees of the manufacturer, so it is possible the results of the trial are biased.
Is it more effective than fish oil?
No studies have been done directly comparing Vayarin with fish oil. On the one hand, Vayarin has a unique composition including phosphatidylserine, theoretically could make it more effective. However, it also has very low levels of DHA and EPA compared to most fish oil preparations used for ADHD. DHA and EPA are thought to be the omega3 fatty acids most important in treatment of ADHD.
Phosphatidylserine is also available over the counter, but no studies have been done to demonstrate its effectiveness or safety.
Phosphatidylserine is also available over the counter, but no studies have been done to demonstrate its effectiveness or safety.
Is it safe?
The main study demonstrating Vayarin's safety was the same trial group as the one that demonstrated effectiveness. The study was continued for 30 weeks and did not demonstrate any major side effects compared to placebo. Although 30 weeks is a long time for a clinical trial, it is not a long time for a product that is meant to be taken daily for years.
On the basis of its ingredients alone, Vayarin should have the side effects of its active ingredients, at least in some patients. It is possible that the number of patients studied was too small to reveal these side effects.
Importantly, Vayarin's capsules used to contain blue dye as one of its inactive ingredients. The manufacturer has changed the coloring to a natural one in order to make the product usable by patients who are sensitive to blue dye.
Also, of theoretical concern is the fact that the source of the phosphatidylserine in Vayarin is bovine cortex. Consuming cow's brains is linked with Creutzfeld-Jacob disease, a form of rapidly progressive dementia. The problem is that while cow's brains may contain prions, the infectious agent that causes Creutzfeld-Jacob disease, they are difficult to detect and even more difficult to disinfect. Cow's brains are strictly regulated in the United States because of this concern. While it is unlikely that a person would contract CJD from a single dose of Vayarin, it is a theoretical concern, particularly in a product meant to be taken over the lifespan of a chronic disease.
On the basis of its ingredients alone, Vayarin should have the side effects of its active ingredients, at least in some patients. It is possible that the number of patients studied was too small to reveal these side effects.
Importantly, Vayarin's capsules used to contain blue dye as one of its inactive ingredients. The manufacturer has changed the coloring to a natural one in order to make the product usable by patients who are sensitive to blue dye.
Also, of theoretical concern is the fact that the source of the phosphatidylserine in Vayarin is bovine cortex. Consuming cow's brains is linked with Creutzfeld-Jacob disease, a form of rapidly progressive dementia. The problem is that while cow's brains may contain prions, the infectious agent that causes Creutzfeld-Jacob disease, they are difficult to detect and even more difficult to disinfect. Cow's brains are strictly regulated in the United States because of this concern. While it is unlikely that a person would contract CJD from a single dose of Vayarin, it is a theoretical concern, particularly in a product meant to be taken over the lifespan of a chronic disease.
Is it more safe than fish oil plus phosphatidylserine?
Fish oil has a number of well known side effects, including fishy tasting burps and possible effects on blood lipid levels.
Phosphatidylserine is not well studied but appears to have few adverse effects.
Phosphatidylserine is not well studied but appears to have few adverse effects.
How does pricing compare with fish oil?
Vayarin is supposed to cost about $55 per month, more or less, depending on the pharmacy. However, this does not include the price of the doctor's visits needed to get the prescription. Fish oil preparations vary widely in cost, with some more and some less than $55 per month. The price of fish oil can be high because large amounts need to be taken in order to get the recommended dose of EPA and DHA.
Who should take Vayarin?
Vayarin is a reasonable choice for people with ADHD who have tried fish oil and experienced side effects or who did not see an effect. Fish oil is probably a better choice for people who only have suspected ADHD (because it does not require a doctor's prescription) or who have not tried an omega 3 supplement before (because fish oil has more clinical trial data to support its effectiveness).
Reference:
Vaya Pharma. "Pricing Information." Vayarin Pricing Information. Vaya Pharma, 2011. Web. 06 January, 2014.
Vaya Pharma. "Flip the Script." Vaya Pharma, 2015. Web. 24 January, 2015.
Vaya Pharma. "Flip the Script." Vaya Pharma, 2015. Web. 24 January, 2015.
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