Eplerenone (e pler' en one; Inspra - Pharmacia), an aldosterone receptor antagonist similar to spironolactone (Aldactone, and others), has been approved by the FDA, but not yet marketed, for treatment of hypertension. It has also been tried for treatment of heart failure.

The FDA has approved an extended-release (XR) formulation of the benzodiazepine alprazolam (Xanax XR - Pfizer) for treatment of panic disorder, with or without agoraphobia. The new formulation is intended to reduce the need for frequent dosing and problems of interdose anxiety. This review describes the effectiveness of the extended-release formulation, as well as sections on dependence, abuse and withdrawal, adverse effects, and drug interactions. The review concludes with an overall assessment of the drug's efficacy and cost.

Enfuvirtide (T-20; Fuzeon Trimeris/Roche), the first in a new class of HIV drugs known as fusion inhibitors, has received accelerated approval from the FDA for use with other antiretrovirals in adults and children with viral replication despite ongoing antiretroviral therapy. This review describes the mechanism of action and pharmacokinetics of the new drug, and outlines the results of the 2 clinical studies that led to its approval. Sections on adverse effects, development of resistance, and dosage and cost are also included. The review concludes with an overall assessment of the...

Bortezomib (PS341; Velcade Millenium), the first proteasome inhibitor, has received accelerated approval from the FDA for treatment of refractory multiple myeloma. This review includes descriptions of the mechanism of action, pharmacokinetics, adverse effects, and dosage and cost of bortezomib, outlines the results of clinical studies, and concludes with an overall assessment of the drug's effectiveness.

Agalsidase beta (Fabrazyme Genzyme) has received accelerated approval from the FDA for treatment of patients with Fabry disease, an inherited lysosomal storage disease caused by deficiency of α-galactosidase A. Agalsidase beta is a recombinant form of human α-galactosidase A. This review provides an overview of this rare disease, including its clinical manifestations. The clinical trials conducted with the new drug are also described, as well as its adverse effects, dosage, and cost. Appropriate indications for use of Fabrazyme are summarized.

The FDA has approved Humatrope, Lilly's brand of recombinant human growth hormone (somatropin), for long-term treatment of children with idiopathic, non-growth-hormone-deficient (NGHD) short stature who are more than 2.25 standard deviations below the mean height for their age and sex. This review describes the clinical studies, adverse effects, and includes a cost table for other brands of somatropin.

Many women of child-bearing age now take folic acid supplements of 400 ╡g per day to prevent neural tube defects in their offspring (Medical Letter 1998; 40:75). An FDA advisory committee has recommended development of a combination tablet containing an oral contraceptive and 400 ╡g of folic acid. A recent editorial in the New England Journal of Medicine suggested that folic acid doses should be higher (NJ Wald, N Engl J Med 2004; 350:101).

Solar ultraviolet (UV) light capable of injuring the skin is classified by wavelength into UVA I (340-400 nm), UVA II (320-340 nm) and UVB (290-320 nm). UVB is responsible for most of the erythema of sunburn. UVA has been implicated in the development of phototoxicity and photoaging. The FDA permits sunscreen manufacturers to claim broad-spectrum protection if their products block at least part of UVA II in addition to UVB.

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The ViewPoint CK System (Refractec) for conductive keratoplasty (CK), previously approved by the FDA as a device for treatment of hyperopia (farsightedness), was recently approved for treatment of presbyopia (age-associated loss of ability to view near objects).

Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).