This winter physicians in many area may see patients suffering from hypothermia. Old age, lack of adequate housing, drug overdose and alcohol ingestion are often prediposing factors, but hypothermia also occurs in healthy young people after prolonged exposure to cold due to incapacitating trauma or cold water immersion. Hypothermia associated with exhaustionduring outdoor sports activities can occur even at relatively mild temperatures.

Trovafloxacin (Trovan - Pfizer) and its prodrug alatrofoxacin (Trovan IV) are new fluroroquinolones marketed for an unusually wide variety of infections, including oral and intravenous treatment of nosocomial and community-acquired pneumonia, acute ecerbations of chronic bronchitis, acute sinusitis, complicate intra-abdominal and pelvic infections, diabetic foot infection, uncomplicated urinary tract infection, prostatitis, cervicitis and uncomplicated gonorrhea.

Argatroban, a small-molecule synthetic derivative of L-arginine, is a direct thrombin inhibitor approved by the FDA for use as an anticoagulant in patients with heparin-induced thrombocytopenia (HIT).

The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.

The FDA has approved Vaxchora (PaxVax), a single-dose, oral, live-attenuated cholera vaccine, to protect against disease caused by Vibrio cholerae serogroup O1 in adults 18-64 years old traveling to cholera-affected areas. Vaxchora is the only cholera vaccine available in the US. A whole-cell killed injectable vaccine was previously approved, but is no longer available in the US.

Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

A variety of continuous glucose monitoring (CGM) devices have been used in an effort to reduce the hypoglycemia and wide glucose excursions that complicate insulin treatment of diabetes. Since the last Medical Letter issue reviewing such devices, some new devices and some new data on old devices have become available. The devices currently marketed in the US for personal use are listed in Table 1.

Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.

The FDA has approved the GABA_A receptor modulator brexanolone (Zulresso – Sage Therapeutics) for IV treatment of postpartum depression (PPD). Brexanolone is the first drug to be approved by the FDA for this indication.

The FDA has asked Impax Laboratories/Teva Pharmaceuticals to stop production and distribution of Budeprion XL 300 mg, a generic extended-release formulation of the antidepressant bupropion (Wellbutrin XL), because it has found that Budeprion XL 300 mg releases bupropion more rapidly than Wellbutrin XL 300 mg, the original brand name product. Patients switched from the brand name to the generic formulation have complained for years that the generic was less effective and caused more side effects than the original formulation. In 2007, ConsumerLab.com, an independent laboratory, conducted...