The fixed-dose combination of olanzapine and fluoxetine (Symbyax - Lilly) has been approved by the FDA for treatment of depressive episodes associated with bipolar disorder. Olanzapine alone (Zyprexa), which is mainly used as an antipsychotic (Medical Letter 2003; 45:102), is FDA-approved for treatment of acute manic episodes and for maintenance treatment of bipolar disorder. Fluoxetine alone (Prozac, and others), which is mainly used as an antidepressant (Medical Letter 2003; 45:93), has no specific approval for use in bipolar...

Botulinum toxin type A (Botox - Allergan) has been approved by the FDA for treatment of severe underarm sweating ("primary axillary hyperhidrosis"). Injected into the skin, botulinum toxin decreases sweating by causing chemical denervation of the sweat gland.

Cinacalcet hydrochloride (Sensipar - Amgen) has been approved by the FDA for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and treatment of hypercalcemia in patients with parathyroid carcinoma.

An orally dissolving, immediate-release tablet formulation of carbidopa/levodopa (Parcopa - Schwarz) that can be taken without water is now available for treatment of Parkinson's disease.

A new albumin-bound formulation of paclitaxel (Abraxane - American Pharmaceutical Partners) has been approved by the FDA for treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. This formulation is free of polyoxyethylated castor oil (Cremophor), a solvent thought to contribute to the hypersensitivity reactions that occur frequently with standard paclitaxel (Taxol, and others) and are severe in about 3% of patients.

In the recent Medical Letter article on the treatment of Clostridium difficile–associated disease (CDAD) we wrote: “Healthcare workers caring for patients with C. difficile infection should follow contact isolation precautions, especially use of gloves and hand washing with soap and water after glove removal. Alcohol-based products such as hand sanitizers will not eradicate C. difficile spores.”1 One reader pointed out that alcoholbased products do eradicate some C. difficile spores and have been invaluable against other pathogens.In an unpublished study available as an abstract, both...

Gadolinium-based contrast agents, which are used mainly for magnetic resonance imaging and angiography, were first introduced partly because of the discovery in the 1990’s that iodine-based contrast agents could cause nephrotoxicity and acute renal failure. Some recent reports have suggested, however, that gadolinium-based agents may also be nephrotoxic.1 One patient who developed acute renal failure after use of gadolinium-based contrast had a renal biopsy that showed acute tubular injury.2Moreover, after exposure to gadolinium-based contrast, some patients with severe renal insufficiency,...

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

Three retrospective studies have recently reported an association between beta-blocker use and a reduction in breast cancer metastasis and recurrence. No prospective, randomized trials have been published.

Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.