The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

Adults with persistent fasting triglyceride levels ≥150 mg/dL are considered to have hypertriglyceridemia; when levels are ≥500 mg/dL, it is considered severe. Hypertriglyceridemia is associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD); severe hypertriglyceridemia increases the risk of acute pancreatitis.

The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.

Obinutuzumab (Gazyva – Genentech), a CD20-directed monoclonal antibody, has been approved by the FDA for treatment of adults with active lupus nephritis who are receiving standard treatment. It was previously approved for treatment of chronic lymphocytic leukemia and follicular lymphoma. Obinutuzumab is the third drug to be approved in the US for treatment of lupus nephritis; the oral calcineurin inhibitor voclosporin (Lupkynis) and the parenteral B-lymphocyte stimulator (BlyS)-specific inhibitor belimumab (Benlysta) were approved earlier.

The FDA has approved Aurlumyn (Eicos Sciences), an IV formulation of the prostacyclin analog iloprost, to reduce the risk of digit amputation in adults with severe frostbite. Iloprost is the first drug to be approved by the FDA for treatment of severe frostbite; it has been used off-label for this indication in the EU and elsewhere for decades. In the US, iloprost is also available as an inhaled formulation (Ventavis) for treatment of pulmonary arterial hypertension.

The most recent guidelines from the Infectious Diseases Society of America (IDSA) and its European counterpart on the choice of antimicrobials for treatment of uncomplicated urinary tract infections (UTIs) in non-pregnant women focus on the unnecessary use of fluoroquinolones to treat uropathogens that are increasingly becoming resistant to them. Resistance of Escherichia coli to ciprofloxacin in the US has increased from 3% in 2000 to 17.1% in 2010.

Orlynvah (Iterum Therapeutics), an oral fixed-dose combination of the thiopenem antibacterial prodrug sulopenem etzadroxil and the renal tubular transport inhibitor probenecid, has been approved by the FDA for treatment of uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in women who have limited or no alternative oral antibacterial treatment options. It is the first oral penem-containing product to be approved in the US.

Indications for preventive treatment of migraine include frequent or severe attacks, contraindications to or toxicity with acute treatments, and patient preference. Drugs for acute treatment of migraine were reviewed in a previous issue.

Lybrel (Wyeth) is the first FDA-approved low-dose combination oral contraceptive taken 365 days a year without a placebo or pill-free interval. All tablets contain low doses of levonorgestrel (0.09 mg) and ethinyl estradiol (20 mcg). Most oral contraceptives are packaged as a 21/7 cycle (21 days of active tablets and 7 days of placebo), resulting in 13 withdrawal bleeding episodes each year. Two formulations are taken for 24 days followed by 4 days of inert tablets (Yaz and Loestrin 24). Two others (Seasonique and Seasonale) have a 91-day cycle with only 4 withdrawal bleeds per...

The FDA has approved the use of ambrisentan (Letairis) and tadalafil (Adcirca) together for treatment of pulmonary arterial hypertension (PAH). It is the first 2-drug regimen to be approved for this indication.