The FDA has approved Furoscix (scPharmaceuticals), a subcutaneous formulation of the loop diuretic furosemide administered via a single-use, on-body infusor, for treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II-III chronic heart failure (HF). Furosemide (Lasix, and generics) has been available for years in oral and IV formulations.

Torsemide, a new loop diuretic similar in action to bumetanide (Bumex) and furosemide, was recently approved by the US Food and Drug Administration for treatment of edema due to congestive heart failure, renal disease, or hepatic disease and also for treatment of hypertension. It is available for both oral and intravenous use.

The FDA has approved Soaanz (Sarfez), a new formulation of the loop diuretic torsemide, for treatment of edema associated with heart failure or renal disease in adults. Torsemide has been available generically for years for treatment of hypertension and treatment of edema due to heart failure, renal disease, or hepatic disease. According to the manufacturer, Soaanz tablets are formulated to provide a gradual and sustained diuresis, lowering the risk of excessive urination and hypokalemia.

A reader has questioned why the label for the COX-2 selective NSAID celecoxib (Celebrex, and generics), which contains a sulfonamide moiety, states that it is contraindicated for use in patients with an allergy to sulfonamides, while the labels of some other sulfonamide drugs recommend either caution or no precautions at all. The concept of cross-reactivity among sulfonamide drugs, particularly between antibacterial and nonantibacterial sulfonamides, has been controversial for many years.

Recent advertisements for indapamide (Lozol - Rorer), an oral antihypertensive/diuretic (Medical Letter, 26:17, 1984), claim that the drug, unlike thiazide diuretics, does not significantly increase serum cholesterol and has a minimal impact on potassium. Indapamide has no thiazide ring but, like chlorthalidone (Hygroton; and others) and hydrochlorothiazide (HydroDiuril; and others), it does have a sulfamoyl benzamide moiety, which is probably responsible for its natriuretic and diuretic effects. Unlike the thiazides, it also has a methylindoline moiety, which apparently decreases...

The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.

Gallium nitrate (Ganite - Fujisawa, USA), originally an anticancer drug, was recently marketed for treatment of cancer-associated hypercalcemia that has not responded to hydration. Other drugs used for treatment of hypercalcemia include furosemide (Lasix, and others), the bisphosphonate etidronate (Didronel IV), calcitonin (Calcimar), and plicamycin (Mithracin, formerly mithramycin) (RAB Schaiff et al, Clin Pharm, 8:108, 1989). Newer bisphosphonates are available in Europe.

Aliskiren (Tekturna - Novartis), the first direct renin inhibitor for treatment of hypertension, has been approved for use in a fixed-dose combination with the diuretic hydrochlorothiazide (Tekturna HCT - Novartis). Many angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are also available in fixed-dose combinations with hydrochlorothiazide (HCTZ).

Vasodilators are widely used for treatment of congestive heart failure (CHF) that has not responded adequately to diuretics and digitalis. Vasodilator drugs redistribute blood volume in patients with heart failure, lowering pressure and reducing volume in the failing left ventricle, which leads to increased cardiac output, decreased pulmonary capillary wedge pressure, and improved exercise tolerance. Since the last Medical Letter review of this subject (Volume 26, page 115, 1984), some additional data have become available.

The FDA has approved macitentan (ma" si ten' tan; Opsumit – Actelion), for oral treatment of pulmonary arterial hypertension (PAH). Macitentan is the second nonselective endothelin receptor antagonist approved for PAH. It is a derivative of bosentan (Tracleer), which is also manufactured by Actelion, and is scheduled to become available generically in 2015. Riociguat (Adempas), another new drug for this indication, will be reviewed in a future issue. Volibris