FDA approves omega-3 fish-oil medication Vascepa to reduce risk of death in people with high cholesterol

The Federal Drug Administration announced late last week that a fish-oil-derived medication, Vascepa, had been approved to prevent heart attacks, strokes and death in people who are at high cardiovascular risk.

"The FDA recognizes there is a need for additional medical treatments for cardiovascular disease," said Dr. John Sharretts, acting deputy director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research, in a press release. "Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events."

Vascepa, which is the only product made by pharmaceutical company Amarin, could be prescribed to millions of patients. The Centers for Disease Control and Prevention report that nearly 95 million Americans have high cholesterol. High cholesterol is a condition in which increased levels of fats, like LDL-C and triglycerides, build up in the blood and raise the risk of heart disease and stroke.

Heart disease remains the No. 1 cause of death in the United States, and approximately every 40 seconds an American will have a heart attack, according to the American Heart Association.

"I believe this is the biggest thing since statins," Dr. Deepak Bhatt, executive director of the Interventional Cardiovascular Program at Brigham and Women’s Hospital Heart and Vascular Center and professor of medicine at Harvard Medical School, told ABC News. He was involved in the long-term study that showed people with high triglycerides who were taking Vascepa had a 25% reduction in the risk of heart attacks, strokes and death compared to the those who received placebo. Results of the study were published in the New England Journal of Medicine in January 2019.

Vascepa is derived from omega-3 fish oil and is the first of its kind to be approved by the FDA as a prescription. It contains the ingredient icosapent ethyl, which is a highly purified and stable EPA ethylester that has been shown to lower triglyceride levels. Although there are over-the-counter omega-3 oils sold as supplements, Dr. Jennifer Ashton, ABC News’ Chief Medical Correspondent told Good Morning America, "According to The American Heart Association, people should avoid unregulated supplements to treat yourself."

Over-the-counter oils may contain a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for coronary heart disease. However, the FDA has concluded that the evidence is inconsistent and inconclusive.

Vascepa sets itself apart because medications that reduce triglyceride levels, such as extended-release niacin and fibrates, have not reduced the rates of cardiovascular events in randomized trials when administered in addition to appropriate medical therapy, including statins, according to the New England Journal.

Researchers are not sure how the mechanism in Vascepa works, but before a doctor can prescribe it there are very specific criteria that a person needs to meet. It is intended only for people with triglycerides over 150 milligrams per deciliter, and the person must currently be on cholesterol-lowering medicine, like a statin, with at least two or more risk factors for cardiovascular disease -- such as smoking, high blood pressure, diabetes or obesity. The medicine is used in addition to a statin. Potential side effects include an abnormal heart rhythm and bleeding.

The retail cost of Vascepa is about $300 a month, according to Amarin, but it is expected to be covered by insurance plans and other payers.

Ian Tink, 69, has high cholesterol, high blood pressure and diabetes and has suffered heart attacks in the past. He recently learned about the drug from his doctor and has been on the medicine for about 10 days because his extremely high triglyceride levels allowed him access before Friday’s approval.

"I expect Vascepa to do well," Tink said. "I have been up against some very serious heart issues, and I have lived with the fact that I am a high-risk patient. Seeing my triglyceride levels come down will be reassuring."

Patients aren't the only one's hopeful about the drug's benefits. The American Heart Association and the American Diabetes Associations have already updated their treatment guidelines to include Vascepa.

Research has shown that Omega-3 fatty acids derived directly from food is known to help heart health, according to Dr. Ashton.

"Two servings a week of natural sources of omega-3 fatty acid including salmon, mackerel, cod and soybeans in recommended by the American Heart Association," she said.

Dr. Blair Chance is a resident physician in preventive medicine at the University of South Carolina and member of the ABC News Medical Unit.