Ibandronate (Boniva - Roche) is the first bisphosphonate approved by the FDA for intravenous (IV) treatment of osteoporosis in postmenopausal women. It is given as a bolus injection once every 3 months. Ibandronate is also available as an oral once-a-month 150-mg tablet and as a daily 2.5-mg tablet.

The American Heart Association has issued its revised guidelines for prevention of infective endocarditis. Antimicrobial prophylaxis for dental procedures is now recommended only for patients at the highest risk of severe consequences from endocarditis who are undergoing the highest-risk procedures. Endocarditis prophylaxis is no longer recommended for gastrointestinal (GI) and genitourinary (GU) procedures. When these changes are implemented, the number of patients receiving antimicrobial prophylaxis to prevent endocarditis should decline sharply.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

Warfarin sodium (Coumadin, and others) and other coumarin anticoagulants prevent thrombosis, but patient response is highly variable and overanticoagulation can lead to hemorrhage. Genotyping patients for single nucleotide polymorphisms (SNPs) that affect coumarin metabolism and sensitivity may help clinicians estimate the therapeutic warfarin dose. The FDA has added a note to warfarin labeling recommending lowrange doses for patients with such genetic variations. Commercial tests for these variants are now available and cost about $500 per test.

Epiduo gel (Galderma), a fixed-dose combination of adapalene 0.1% (Differin), a synthetic retinoid analog, and benzoyl peroxide (BPO) 2.5%, an oxidizing agent, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

Telaprevir (Incivek – Vertex) and boceprevir (Victrelis – Merck) have been approved by the FDA for oral use in combination with peginterferon and ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults with compensated liver disease. Both telaprevir and boceprevir were developed specifically to inhibit the NS3/4A proteases that cleave HCV encoded polyproteins of the genotype 1 virus.

The FDA has approved ezogabine (ee-ZOE-ga-been; Potiga – GSK/Valeant) for oral adjunctive treatment of partial-onset seizures in adults. Ezogabine is available in Europe as retigabine (Trobalt).

Two new injectable GLP-1 (glucagon-like peptide-1) receptor agonists, dulaglutide (Trulicity [trū li si tee] – Lilly) and albiglutide (Tanzeum [tan' zee um] – GSK), have been approved by the FDA for once-weekly treatment of type 2 diabetes. Other available GLP-1 receptor agonists include exenatide, which is approved for injection twice daily (Byetta) or once weekly (Bydureon), and liraglutide (Victoza), which is injected once daily.

The FDA has approved ivabradine (Corlanor – Amgen) to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35% who are in sinus rhythm with a resting heart rate ≥70 beats per minute and who are on maximum tolerated doses of beta blockers or have a contraindication to beta blocker use. Ivabradine has been available internationally for years as Procoralan and Corlentor for treatment of stable angina and heart failure.