The Food and Drug Administration has approved a prescription formulation of omega-3 fatty acids that offers patients at risk for heart disease a simpler way to ensure they are getting enough of the substance.
The drug, Omacor, was approved in November as an adjunct to diet to help reduce triglycerides in patients with levels of more than 500 mg/dL. Each 1-g capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids, primarily eicosa-pentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), according to the drug's label.
That makes it much more potent than most of the over-the-counter fish oil supplements, and because it is produced according to FDA's good manufacturing practice standards, Omacor may be of higher quality than OTC supplements, said William Harris, Ph.D., director of lipid research at the Mid America Heart Institute in Kansas City, Mo.
“I think Omacor really is an advance in omega-3s,” said Dr. Harris, coauthor of the American Heart Association Nutrition Committee's recommendations on fish oil and an investigator in the FDA approval trial for Pronova Biocare AS, a Norwegian company that developed Omacor. In that study, 84 patients with severe hypertriglyceridemia (with an average 900 mg/dL) were randomized to placebo or Omacor. Patients taking Omacor had a 45% drop in triglyceride levels. Dr. Harris has received no other financial support from the company.
The AHA recommended in 2002 that patients with documented coronary heart disease should consume at least 1 gram of omega-3 fatty acids daily. Ideally, the omega-3s should come from fatty fish, but the AHA said that patients could take supplements.
To lower triglycerides, patients need to consume at least 2–4 g of omega-3 fatty acids daily, according to the guidelines. Omacor or OTC fish oil should be used in conjunction with niacin or fibrate therapies, Dr. Harris added.
The label recommends that patients taking Omacor have their triglyceride levels closely monitored, and that if they don't respond within 2 months, the drug should be stopped. Patients taking anticoagulants should also be monitored, as there have been some reports of prolonged bleeding with omega-3s.
Reliant Pharmaceuticals Inc. will market Omacor in the United States.