The FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the drug to include new warnings about the risk of QT interval prolongation.

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).

Perindopril, the tenth angiotensin converting enzyme (ACE) inhibitor to be marketed in the USA, and telmisartan and eprosartan, the fifth and sixth angiotensin receptor blockers, have recently become available for treatment of hypertension.

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.

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...

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.

Flecainide (Tambocor -3M Pharmaceuticals), first introduced in 1985 for treatment of ventricular arrhythmias, was recently approved by the US Food and Drug Administration for oral use to prevent supraventricular arrhythmias. The indications for using flecainide to treat ventricular arrhythmias were limited after a controlled trial found that post-myocardial infarction patients with asymptomatic ventricular arrhythmias who took the drug had twice as high a mortality rate as patients who took placebo (DS Echt et al, N Engl Med, 324:781, 1991).

Carteolol (Cartrol - Abbott) and penbutolol (Levatol - Reed & Carnrick), two oral beta-adrenergic blocking drugs, were recently approved by the US Food and Drug Administration for once-daily treatment of systemic hypertension. Both drugs are non-selective beta-blockers with mild partial agonist activity. Beta-blockers currently available in the USA for treatment of hypertension are listed in the table on the next page.

Ibutilide fumarate (Corvert - Pharmacia & Upjohn), a new antiarrhythmic drug for intravenous use, has been approved by the US Food and Drug Administration for acute termination of atrial fibrillation or flutter of recent onset.

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.