The FDA has removed a boxed warning from the labeling of products containing the sodium-glucose co-transporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet, Invokamet XR) that described an increased risk of lower limb amputation associated with use of the drug. Package inserts for canagliflozin products still contain a standard warning about a risk of lower limb amputation.

Tinidazole (Tindamax - Mission Pharmacal), an oral antiprotozoal drug available in the US since 2004 for treatment of trichomoniasis, giardiasis, amebiasis and amebic liver abscess, was recently approved by the FDA for treatment of bacterial vaginosis.

The FDA has approved patiromer (Veltassa – Relypsa), an oral potassium binder, for treatment of hyperkalemia. It is the first drug to be approved for this indication since the cation-exchange resin sodium polystyrene sulfonate (Kayexalate, and others) in 1958. Patiromer is not indicated for emergency correction of life-threatening hyperkalemia. Sodium zirconium cyclosilicate, another oral potassium binder, is currently being reviewed by the FDA; a decision on its approval is expected in May 2016.

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

Trospium chloride (Sanctura - Indevus/Odyssey) has been approved by the FDA for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. It has been available in Europe for many years.

The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton mentagrophytes. It is the first topical triazole antifungal drug to be approved for this indication. A topical oxaborole antifungal solution, tavaborole 5% (Kerydin – Anacor), also recently approved by the FDA for the same indication will be reviewed in a future issue.

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

An intravenous formulation of amiodarone (Cordarone IV -Wyeth-Ayerst) has been approved by the US Food and Drug Administration (FDA) for treatment and prophylaxis of recurrent ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

Tiagaine (Gabitril - Abbot), a gamma-aminobutyric acid (GABA) uptake inhibitor, has been approved by the FDA for oral use as an adjunct to other drugs for treatment of partial seizures in patients more than 12 years old. Since most adult patients with resistant epilepsy have partial seizures, new antiepileptic drugs are usually tried first for this indictation.

Propafenone (Rythmol - Knoll), a class IC antiarrhythmic drug used in Europe for treatment of various arrhythmias for more than 10 years, was recently marketed in the USA for oral treatment of life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. This restrictive labeling reflects concerns arising from the interim report of the Cardiac Arrhythmia Suppression Trial, in which post-myocardial infarction patients with asymptomatic or mildly symptomatic ventricular arrhythmias treated with the class IC antiarrhythmic drugs encainide (Enkaid) or flecainide...