The recombinant interleukin-1 (IL-1) receptor antagonist anakinra (Kineret – Sobi) has been granted an FDA Emergency Use Authorization (EUA) for treatment of hospitalized adults with confirmed COVID-19 pneumonia who require low- or high-flow supplemental oxygen, are at risk of progressing to severe respiratory failure, and are likely to have elevated plasma levels of soluble urokinase plasminogen activator receptor (suPAR). Anakinra has been available in the US for years; it is FDA-approved for multiple indications, including rheumatoid arthritis. Assays for suPAR are...

Topiramate (Topamax - Ortho-McNeil) has been approved by the US Food and Drug Administration (FDA) for oral use as an adjunct to other drugs in adult patients with partial seizures. Since this diagnostic category includes the largest number of patients with refractory epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Topiramate (toe pyre' a mate) is a structurally unique agent chemically related to the D-enantiomer of fructose.

Micronized fenofibrate (Tricor - Abbott), a fibric acid derivative structurally similar to clofibrate (Atromid-S, and others) and gemfibrozil (Lopid, and others), has been approved by the FDA for treatment of hypertriglyceridemia. Increased serum triglyceride concentrations have been associated with an increased risk of coronary heart disease (J Jeppesen et al, Circulation, 97:1029, 1998).

Creatine, a natural amino acid derivative, and androstenedione, a testosterone precursor, are marketed as 'dietary supplements' in health food stores and are widely believed to enhance athletic performance. Both have been in the news recently because Mark McGwire, the baseball home-run record-setter, reportedly has said he takes both. Neither has been approved for any indication by the US Food and Drug Administration (FDA).

Spironolactone, an aldosterone receptor antagonist, has been FDA-approved for many years for treatment of edema, hypertension and primary hyperaldosteronism. Recently, it was reported to improve morbidity and mortality in patients with severe heart failure.

Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and life-threatening infection....

Apremilast (Otezla – Celgene), an oral phosphodiesterase type-4 (PDE4) inhibitor, has been approved by the FDA for treatment of active psoriatic arthritis in adults. It is the fi rst PDE4 inhibitor to be approved for this indication.

Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the FDA initially only as adjunctive treatment for partial seizures. Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the S-isomer of the active metabolite of oxcarbazepine. Oxcarbazepine itself is similar to carbamazepine. Both oxcarbazepine and carbamazepine are available generically.

In recent years, several new drugs have been approved by the FDA for use in multiple sclerosis (MS), and many others are in the pipeline. Most recently, teriflunomide (Aubagio – Genzyme) became the second oral drug to be approved by the FDA for treatment of relapsing forms of MS.

Flutamide (Eulexin - Schering), an oral antiandrogen, is now available in the USA for treatment of metastatic prostate cancer. Flutamide is recommended by the manufacturer only for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron - Medical Letter, 27:71, 1985).