Vascepa side effects and how to avoid them

Vascepa side effects | Serious side effects | Bleeding | Atrial fibrillation | How long do side effects last? | Warnings | Interactions | How to avoid side effects | Resources

Vascepa is a brand-name prescription drug used to improve cardiovascular outcomes in people with cardiovascular disease or Type 2 diabetes who have risk factors for heart attack, stroke, or other cardiovascular problems and are already taking statins . Vascepa is also FDA-approved as an adjunct to diet and exercise to reduce triglyceride levels in people diagnosed with severe hypertriglyceridemia, or severely high triglyceride levels. 

Icosapent ethyl, the active ingredient in Vascepa, is an omega-3 fatty acid similar to eicosapentaenoic acid (EPA) which, along with docosahexaenoic acid (DHA), is found in fish oil. When taken in high doses, EPA and DHA significantly lower both triglycerides and  LDL (“bad”) cholesterol. Although Vascepa is very similar to an omega-3 fatty acid supplement, it does have side effects and potentially serious drug interactions.

RELATED: Learn more about Vascepa

Common side effects of Vascepa

The most common side effects of Vascepa are:

• Bleeding, including nosebleeds
• Muscle and joint pain
• Swelling of the extremities
• Constipation
• Gout

Serious side effects of Vascepa

The most serious side effects of Vascepa include:

• Severe bleeding
• Atrial fibrillation
• Atrial flutter

Vascepa and bleeding

Omega-3 fatty acids, both EPA and DHA, prevent platelets, the blood cells responsible for clotting, from clumping together to form blood clots. As a result, bleeding problems are the most common and serious side effect of Vascepa or any high-dose omega-3 fatty acid. In clinical studies, approximately 12% of people taking Vascepa experienced bleeding episodes of some kind and 3% experienced severe bleeding episodes. Bleeding is an important and potentially hazardous side effect, so healthcare professionals will be cautious about prescribing Vascepa to people with pre-existing bleeding problems or risk factors for bleeding, including taking anticoagulants such as warfarin.

Vascepa and atrial fibrillation

Vascepa treatment is associated with a higher incidence of severe atrial fibrillation and atrial flutter. In clinical trials, 3% of patients treated with Vascepa required hospitalization for atrial fibrillation or flutter compared to 2% of patients receiving a placebo. Those who already have atrial fibrillation are  most likely to be hospitalized while taking Vascepa. 

Atrial fibrillation and atrial flutter are types of heart rhythm problems affecting the upper chambers of the heart. Talk to a healthcare provider if any of the following symptoms of atrial fibrillation are experienced while taking Vascepa:

• Irregular or fast heartbeat
• Lightheadedness
• Shortness of breath
• Fainting

How long do side effects last?

EPA has a half-life of 89 hours—almost four days. Side effects such as bleeding, constipation, joint pain, and swelling should fade by that time. At the very least, side effects shouldn’t persist for longer than three weeks, which is how long it takes for the majority of the medication to be eliminated after discontinuing it. Serious side effects such as severe bleeding episodes or blood clots caused by atrial fibrillation may have long-term complications.

Vascepa contraindications & warnings

Unlike most prescription drugs, fish oils like EPA generally do not have a long or worrisome list of potential problems. However, Vascepa is a high-dose omega-3 fatty acid, so it requires more caution than simply taking an occasional omega-3 supplement. 

Abuse and dependence

The U.S. Food and Drug Administration (FDA) does not consider omega-3 fatty acids, EPA, icosapent ethyl, or other dietary lipids to be addictive drugs or have a potential for abuse. Vascepa can be discontinued without causing withdrawal symptoms.

Overdose

Taking too much omega-3 fatty acids is generally not considered a problem in healthy adults. However, Vascepa is used in people with often serious metabolic, heart, or circulation problems. High doses of omega-3 fatty acids like Vascepa could cause potentially serious side effects such as bleeding or irregular heartbeats. If too much Vascepa is taken, always call a poison helpline or get medical attention. 

Restrictions

Vascepa has few restrictions. The only contraindication is a known hypersensitivity to any of the ingredients in Vascepa. However, this does not necessarily include allergies to fish or shellfish. Healthcare providers are uncertain if fish or shellfish allergies make people more likely to have an allergic reaction to Vascepa, so they will advise patients with these allergies to watch for signs of an allergic reaction such as hives, trouble breathing, or swelling of the face, throat, or mouth. If an allergic reaction is suspected, immediately stop taking Vascepa and get medical attention.

Vascepa interferes with the body’s ability to form blood clots, so there’s an increased risk of prolonged or serious bleeding. Vascepa is used cautiously in people who have an increased risk of bleeding or take blood thinners such as warfarin.

Some people are at an increased risk for severe atrial fibrillation or atrial flutter requiring hospitalization while taking Vascepa. However, these side effects are more likely in people who already have been diagnosed with atrial fibrillation. Vascepa can be prescribed to people with atrial fibrillation, but they may require heart monitoring.

Pregnancy and breastfeeding

Women who are pregnant, considering pregnancy, or breastfeeding should inform their prescribing healthcare providers before taking Vascepa. There may be risks associated with Vascepa, so women should get medical advice about the pros and cons of taking Vascepa while pregnant or breastfeeding.

There are no human studies to determine if Vascepa is safe to take while pregnant. Healthcare providers are cautious about its use during pregnancy because animal studies show an increased risk of fetal harm and death.

It’s uncertain if Vascepa is safe to take while breastfeeding. Omega-3 fatty acids are naturally present in human breast milk, but taking omega-3 fatty acids while lactating does increase the amount of omega-3 fatty acids in breast milk. Healthcare providers do not know if elevated EPA levels in breast milk cause complications in nursing infants.

Children

The U.S. Food and Drug Administration (FDA) has not approved the use of Vascepa in children.

Seniors

People older than 65 years are given Vascepa in the same doses as younger adults. Clinical trials found no difference in the effectiveness or safety of Vascepa in seniors compared to younger adults. 

Vascepa interactions

As an omega-3 fatty acid, Vascepa’s active ingredient is commonly found in cold-water fish, such as salmon, as well as numerous dietary supplements. As a nutrient, omega-3 fatty acids have few and minimal drug interactions. Still, Vascepa is a prescription high-dose omega-3 fatty acid, so healthcare providers do need to know about all the prescription drugs, over-the-counter medicines, dietary supplements, and alternative remedies being taken.

High doses of omega-3 fatty acids increase the risk of bleeding episodes. As an antiplatelet agent, omega-3 fatty acids interfere with the blood cells (platelets) that aggregate together to form blood clots. Bleeding episodes and the risk of severe bleeding increase if Vascepa is combined with other drugs that also interfere with blood clotting. The most notable are:

• Blood thinners such as warfarin 
• Drugs containing aspirin (acetylsalicylic acid)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
• Selective serotonin reuptake inhibitors (SSRIs)
• Serotonin and norepinephrine reuptake inhibitors (SNRIs)
• Niacin
• Some cancer drugs

Additionally, some beta blockers, drugs used to treat high blood pressure or irregular heartbeats, reduce the ability of Vascepa to bring down triglyceride levels in the blood.

How to avoid Vascepa side effects

Although Vascepa has minimal side effects, there are ways to reduce the risk of them while maximizing the benefits of taking Vascepa.

1. Tell the prescribing healthcare provider about all medical conditions

No matter what drug is being prescribed, the first step in avoiding possible side effects is to make sure the prescribing healthcare provider has a complete medical history. When getting a Vascepa prescription, the healthcare provider particularly needs to know about:

• Bleeding risk factors
• Diabetes
• Hypothyroidism (underactive thyroid)
• Pancreas problems or a history of pancreatitis (swollen pancreas)
• Allergies to fish or shellfish
• Kidney problems
• Pregnancy or pregnancy plans
• Breastfeeding or breastfeeding plans

2. Tell the healthcare provider about all medications being taken

Vascepa has few drug interactions, but some of them can be serious. Whenever getting a prescription, make sure the prescribing healthcare provider has a complete list of all drugs, supplements, and alternative medicines being taken. To prevent bleeding problems when taking Vascepa, make sure the prescribing healthcare provider knows about any drug that affects blood clotting.

3. Take Vascepa as directed

Follow the instructions given by a healthcare provider, written on the prescription label, or outlined in the patient information insert included with the medicine. Do not take extra doses, do not skip doses, and do not stop this medication until talking to a healthcare professional. Vascepa must always be taken with a meal. Swallow the capsules whole with a glass of water.

4. Take the correct dose

The daily dose is four grams: two grams in the morning and two grams later in the day. However, Vascepa comes in two different dosage strengths, 0.5 grams and 1 gram, so make sure the capsule count is correct when taking a dose. This may be either  taking eight 0.5 gram capsules (four capsules per dose)) or four 1 gram capsules (two capsules per dose).

5. Do not miss doses

Vascepa must be taken twice per day every day. It may take years of daily dosing to realize the full benefits of this drug in reducing cardiovascular risk. There are a variety of helpful tools to help remember when to take a dose: alarms, smartphone apps, daily pillboxes, and bottle cap alarms. Remember, a missed dose can be taken on the same day it was missed to ensure the total daily dose is taken, even if it’s almost time for the next dose that day. However, doses from previously missed days should not be taken in order to prevent going above the recommended daily dose.   

6. Stick to the prescribed diet

For all the indications for which Vascepa is used, a doctor, nutritionist, or other healthcare professional will almost always prescribe or advise a low-cholesterol, low-fat diet. The prescribed diet may also limit sugars, carbohydrates, calories, or alcohol. To get the maximum benefit from treatment, stick to this diet rigorously.

7. Get medical help at any sign of bleeding problems

Bleeding is a side effect of high-dose omega-3 fatty acid treatment, but it does not have as high of a risk as other drugs that interfere with blood clotting. Still, be on the lookout for increased bleeding and call a healthcare provider for medical advice if bleeding becomes a problem. Severe or overly prolonged bleeding will require medical attention.

Bleeding can happen inside the body where it can’t be seen. Be aware of signs of internal bleeding such as blood in the urine (the urine will turn pink, red, or brown), blood in the stools (stools will turn red or black), blood or blood clots (“coffee grounds”) in vomit, and coughing up blood. Other signs of internal bleeding include headaches, dizziness, fainting, and weakness. Call a healthcare provider if any of these symptoms occur.

Resources

• Icosapent ethyl drug summary, Prescriber’s Digital Reference
• Vascepa, Epocrates
• Vascepa prescribing information, U.S. National Library of Medicine