You know that getting omega-3 EPA and DHA from your diet (including adding nutritional supplements to a healthy diet) can be beneficial for you as this essential polyunsaturated fatty acid can confer heart health benefits and so much more. Did you know that for some people, there is another way to get your omega-3s for heart health, and that’s through a prescription medication.
In today’s blog, we’re going to share information about some of the similarities and some of the differences between omega-3 EPA and DHA supplements and omega-3 prescription medications to help you consider, which might be right for you.
But first, a brief intro about omega-3 fatty acids.
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Omega-3 Fatty Acids 101
Here are the four basics you need to know about omega-3 fatty acids:
- Omega-3 fatty acids are polyunsaturated fats (PUFAs)—the “good” fats, as opposed to unhealthier fats such as saturated fats or the really unhealthy fats known as trans-fats. Omega-3s are considered “essential” meaning that your body doesn’t produce them on its own, so they can only be obtained through your diet (including nutritional supplements) or, in very specific cases (we’ll get to those), as prescription medications.
- Omega-3 fatty acids have a variety of potential benefits for your health, especially for cardiovascular health and reducing inflammation. There is a wide (and deep) body of research supporting omega-3 fatty acids for other areas too, including for joint health, eye health, brain health, maternal health during pregnancy, and growth and development for the fetus. Omega-3s have been studied in numerous other areas, too, and also show promise for reducing risks for some cancers and other chronic diseases, for stress, improving sports performance, and more.
- When it comes to diet, omega-3 fatty acids can be found in salmon and other fatty fish which are among the richest sources, and for vegetarians and vegans from plant-based foods like walnuts, edamame, flax or chia seeds, and algae.
- Omega-3 fatty acids contain different components. The most popular—and the most studied—are fish-oil based and are known as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Plant-based omega-3s contain alpha-linolenic acid (ALA).
What is an Omega-3 Supplement?
Dietary supplements are regulated by the U.S. Food & Drug Administration (FDA) as a category of food under the Dietary Supplement Health and Education Act (DHSEA). The Federal Trade Commission (FTC) is the federal agency that regulates dietary supplement marketing and both agencies work cooperatively as needed. Read more here and here.
To qualify as a dietary supplement, the product must be:
- ingestible, specifically swallowed and can come in a variety of forms including pills, capsules, tablets, gummies, soft gels, liquids and powders, bars, as some examples
- intended to be added to the diet
- labeled as a dietary supplement and any health claims must adhere to the regulations for that labeling. Further, the product manufacturer must have on file substantiation that the claim being made is truthful and not misleading.
What Qualifies as an Omega-3 Prescription Medication?
Prescription medications are also regulated by FDA, with the agency having responsibility for approving new drugs to the market, and for ensuring prescription medications are safe, high quality, and provide benefits. Prescription drugs are monitored for safety and quality even after they’re on the market, according to FDA. Read more here.
There is a four-step process involved in bringing a drug to market, and a time frame that usually lasts a minimum of a decade, according to this article. The four phases involve: discovery, preclinical studies, clinical development and market approval. Read more here.
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There are currently two FDA approved omega-3 brand name drugs on the market while a third, known as Epanova, was removed by the brand manufacturer during the pre-market approval process due to the determination that the clinical trial—which was stopped—show some indication of a health risk and only a low probability of a clinical benefit.
Let’s talk about the two brand name drugs:
Vascepa
Vascepa contains 960 mg of omega-3 fatty acid ethyl esters of EPA only. The dose for adults is 4 grams daily, taken either as two 1-gram capsules twice daily or four 0.5-gram capsules twice daily.
The clinical trial: Published in the New England Journal of Medicine in 2019, REDUCE-IT supported the use of Vascepa for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia. This multi-center, randomized, double-blind placebo-controlled trial involving 8,179 patients with established cardiovascular disease or diabetes, and who were on statin therapy and had a fasting triglyceride level of 135 to 499 mg per deciliter, were followed for a median of 4.9 years.
The patients were randomly assigned to receive 2 grams of icosapent ethyl twice daily or placebo. The results demonstrated a 25% reduction in major adverse cardiovascular events in the EPA-only formula in high-risk patients treated with a statin.
The health claim from the Vascepa website says that the prescription medication is the “first and only FDA-approved medication to lower CV risk in addition to other medications, such as statins, in patients with triglycerides (≥150 mg/dL) and heart disease or diabetes with other CV risk factors.”
Lovaza
Lovaza’s formula is also a concentrated omega-3 fatty acid ethyl ester, but it contains two omega-3s, EPA (465 mg) and DHA (375 mg) for a combined 840 mg of EPA+DHA per capsule. The dose (for adults) is 4 grams daily, taken either in a single dose or in two 2-gram doses.
According to Drugs.com, both Vascepa and Lovaza may lower very high and potentially dangerous triglycerides in your blood. Unlike Vascepa, Lovaza is not approved to be used with a statin but is used in addition to a lipid-lowering diet.
There are at least two generic omega-3 prescription medications on the market: Icosapent Ethyl (generic for Vascepa) and Omega-3-Acid Ethyl Esters (generic of Lovaza). It is suggested that those on either the brand or generic medications also follow a low-cholesterol diet and regular exercise program.
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What’s the Difference Between an Omega-3 Supplement and an Omega-3 Prescription Medication?
Do you know that there are some ingredients found in supplements that are also available as prescription medications? For example, vitamin D and Niacin, a B vitamin, are two such examples. The prescription medications require a doctor’s written order and are prescribed for specific purposes. Both vitamin D and Niacin are also available as dietary supplements with no doctor’s order needed.
And then there’s omega-3 EPA and DHA, another dietary supplement that you can also get with a doctor’s prescription. So, what is the difference between an omega-3 supplement and an omega-3 prescription medication?
Both have benefits, so how do you choose? In some cases, the choice is made for you. For example, in the case of Vascepa, the omega-3 prescription medication is only available for patients with a diagnosis of severe (≥ 500 mg/dL) hypertriglyceridemia and those at very high risk for cardiovascular disease (CVD) and some other requirements. Learn more here and here.
Talk with your doctor to determine if you are eligible for an omega-3 prescription medication and, if so, talk with your health insurance provider about coverage.
Here are some other differences between the two:
- Omega-3 supplements have a variety of uses for a variety of consumers at a variety of doses, whereas omega-3 prescription medications are prescribed to specific patients who have serious cardiovascular issues.
- Omega-3 prescription medications are traditionally in ethyl ester form; some, but not all, omega-3 dietary supplements are available as ethyl esters, but there are also those that contain natural triglycerides, phospholipids and/or free fatty acids.
- Dietary supplements cannot make the same kinds of health claims as prescription medications. Dietary supplements by law cannot claim to prevent or treat heart disease and those that do are considered illegal drugs.
- Prescription medications may be covered by insurance whereas dietary supplements are not.
- Prescription medications require FDA approval to get to market and have post-market surveillance. Dietary supplements are not approved by FDA before going to market, but there are regulations in place focused on good manufacturing processes, labeling and more, and a post-market program for monitoring serious adverse events should they occur.
- Both omega-3 dietary supplements and omega-3 prescription medications have strong safety profiles. Talk with your doctor for more information about potential side effects.
- Your doctor will have control over whether you can continue to be prescribed the omega-3 medication; you’ll have control over whether you’ll keep your doctor involved in your continued use of your omega-3 dietary supplements.
Our advice: heart disease is a serious concern; include your doctor in discussions not only about your omega-3 prescription medication but also about your omega-3 supplement use and whether or not a high dose omega-3 supplement is the right thing for you.
More Food for Thought
According to William S. Harris, Ph.D., president and founder of The Fatty Acid Research Institute (FARI) and founder of OmegaQuant, the EPA and DHA chemicals found in the omega-3 prescription medications and the omega-3 EPA and DHA supplements “are essentially the same.” It’s even possible to purchase the same amount of EPA and DHA found in the prescription medication in a dietary supplement.
The main differences between omega-3 EPA and DHA supplements and omega-3 prescription medications, says Dr. Harris, come in the form of the regulation, including the subsequent health claims that are allowed, he says.
And here’s where it gets interesting. As previously discussed, to get regulatory approval to market omega-3s as a prescription medication, among the things that pharmaceutical companies must do, is conduct a clinical trial to demonstrate safety and benefits of its formulation. In the case of omega-3 prescription medications, the strong results provided substantiation allowing for strong health claims to be made by the manufacturer and marketer.
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For a dietary supplement company to make the same claims, it would need to do its own clinical trial. And while that might sound simple, it’s more complex. Here’s why.
It takes a lot of money to fund a clinical trial. As for the price of bringing a new drug to market, this study noted estimates for R&D costs as high as $4.46 billion.
In 2023, the U.S. pharmaceutical market was valued at $574.37 billion while the dietary supplement industry was estimated at $53.58 billion for the same year.
That’s not all. When a new prescription medication is approved and subsequently introduced to the market in the U.S., FDA grants a guaranteed period during which a generic version cannot be approved, regardless of the time remaining on the new drug’s patent, says this article. That period generally lasts for at least six years but can go higher.
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On the other hand, dietary supplement regulation does not allow that same protectionary exclusivity benefit, making the cost for a similar clinical trial exorbitant and likely not recoupable for the dietary supplement company.
Dr. Harris says that “the assumption is that the same dose of EPA and DHA, whether in a ‘drug’ or ‘supplement’ will have the same effect as found in the clinical trial.” As an example, he explains that 4 grams (3.45 grams of EPA+DHA) of Lovaza was shown to lower triglycerides in people with very high triglycerides, so any product that provides 3.45 grams of EPA+DHA would be expected to do the same thing.”
Yet, he adds, the prescription medication gets to use the results of the trial in their marketing claims, while the supplement companies with very similar formulas can only say their omega-3 product “supports heart health.”
The differences in regulation may be a good thing, though, leaving room in the market for both kinds of products—omega-3 supplements and omega-3 prescription medications—and the ability for consumer choice.
One more thing to know: To learn whether you’re truly accessing the benefits of omega-3 EPA and DHA, be sure to test your blood levels regularly. Learn more here.
