FDA Approves New Omega-3 Supplement — Physician’s First Watch

Medical News |
May 7, 2014

FDA Approves New Omega-3 Supplement

By Larry Husten

The FDA has approved a new omega-3 supplement (brand name, Epanova) to treat adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher.

In its announcement, the manufacturer said that Epanova is the first omega-3 formulation approved by the FDA in free fatty acid form. It will be available in 1-g capsules and has been approved for 2-g and 4-g dosages, which can be taken with or without food.

There are currently two other prescription formulations of omega-3 supplements on the market: Lovaza and Vascepa. All three are approved only for the treatment of severe hypertriglyceridemia, though studies of expanded indications are underway.

Reader Comments (2)

M.S. Other Healthcare Professional, Other, Retd. Res. Scientist & chair/HIV/AiIDS Conf Cmte/NYC Health Dept.

In a case of 'brittle Hypo-glycemia' (25mg% at 3 1/2 hrs. into glucose tolerance test).) would a result of moderate to high triglceride levesl be expected in a fasting specimen??

DAVID KELLER Physician, Internal Medicine, disabled

The 2012 Endocrine Society recommendations raised the threshold definition of severe elevation of triglycerides, requiring pharmacological treatment to reduce the risk of pancreatitis, to greater than or equal to 1000 mg/dL (1). The older threshold of 500 mg/dL was determined to present a much lower risk of pancreatitis than had been previously thought.

1. Berglund L, Brunzell J, Goldberg A, et al. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97:2969-2989.

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