Labeling updates and warnings through August 2008 for abacavir (Ziagen) and abacavir-containing agents (Epzicom, Trizivir) and ciprofloxacin (Cipro), ciprofloxacin extended-release (Cipro XR. Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin).

In the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) investigators observed that dronedarone, an anti-arrhythmic agent related to amiodarone, was associated with increased mortality in patients who were hospitalized for symptomatic heart failure (HF) (New York Heart Association [NYHA] class II, III, or IV) and left ventricular systolic dysfunction.

Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.

Labeling changes and safety information regarding Botox, selected antiepileptic drugs, Chantix, and Ortho Evra (through March 2008)

The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.

Patients with glucocorticoid-induced osteoporosis who are at high risk for fracture may experience greater increases in bone mineral density (BMD) with teriparatide than with alendronate, according to an 18-month, international, randomized, double-blind, controlled trial that included 428 patients.

Labeling updates and warnings through January 2008 for mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin

Labeling updates and warnings related to rosiglitazone, erythropoiesis-stimulating agents, and aprotinin (December 2007)

According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.