The FDA has approved Relyvrio (Amylyx), a fixed-dose combination of sodium phenylbutyrate and taurursodiol, for treatment of amyotrophic lateral sclerosis (ALS). Sodium phenylbutyrate (Buphenyl, and others) has been available by prescription for years for treatment of urea cycle disorders. Taurursodiol (tauroursodeoxycholic acid), a derivative of ursodiol, is an over-the-counter bile acid supplement claimed to have neuroprotective benefits. Relyvrio is the third drug to be approved in the US for treatment of ALS; riluzole (Rilutek, and others) and edaravone (Radicava, Radicava...

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

A synthetic form of the protein apoaequorin is the active ingredient in the over-the-counter dietary supplement Prevagen (Quincy Bioscience), which is heavily marketed to improve memory.

Many readers have asked the Medical Letter to evaluate St. John's wort, an herbal extract now widely sold in health food stores and pharmacies, for its effectiveness and safety in the treatment of depression. St. John's wort is licensed in Germany for treatment of anxiety, depression and insomnia. In the USA, it is considered a dietary supplement and has not been evaluated by the FDA.

Management of intermittent claudication, the most common symptom of peripheral arterial disease (PAD), involves both risk factor modification and symptomatic treatment (WR Hiatt, N Engl J Med 2001; 344:1608; RM Schainfeld, J Am Board Fam Pract 2001; 14:443).

Supplemental calcium is recommended for prevention of postmenopausal osteoporosis in women with an inadequate dietary intake of calcium. The safety of calcium supplements has recently been questioned; patients may ask if they should continue to take them. The source of this concern was the publication of 2 meta-analyses in the British Medical Journal.

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

Icosapent ethyl (Vascepa – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA for use as an adjunct to maximally tolerated statin therapy to reduce the risk of major adverse cardiovascular events in adults with hypertriglyceridemia (≥150 mg/dL) who have either established cardiovascular disease (CVD) or diabetes and ≥2 additional risk factors for CVD. It is the only omega-3 polyunsaturated fatty acid (PUFA) product to be approved in the US for this indication. Icosapent ethyl and two other omega-3 PUFA prescription products (Lovaza, Epanova),...

The US Food and Drug Administration has ordered removal of phenylpropanolamine from over-the-counter cold remedies and weight loss aids. The FDA based its decision on a recent study showing an increased risk of hemorrhagic stroke in young women taking the drug.

The FDA has approved the melatonin receptor agonist tasimelteon (Hetlioz – Vanda) for treatment of non-24-hour sleep-wake disorder (non-24), which is common in totally blind persons. Tasimelteon is the first drug approved for this indication and the second melatonin receptor agonist approved for use in the US; ramelteon (Rozerem) was approved earlier for treatment of insomnia. Melatonin itself has not been approved by the FDA for any indication; it is available in the US as a dietary supplement and is promoted as a sleep aid.