The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

Recombinant activated coagulation factor Vll (rFVIIa; NovoSeven - Novo Nordisk), which is marketed worldwide for treatment of bleeding episodes in hemophilia patients with inhibitors to factor VIII or IX, is now being used off-label to stop bleeding in patients who do not have hemophilia. An article in the lay press reported that one or two doses has stopped previously uncontrollable bleeding due to gunshot wounds (B Wysocki, Jr, Wall St Journal, March 17, 2004, page B1).

Palifermin (Kepivance - Amgen), a recombinant human keratinocyte growth factor (KGF), has been approved by the FDA to decrease the incidence and duration of severe oral mucositis (OM) in patients with hematologic malignancies receiving myelotoxic chemotherapy and hematopoietic stem cell (HSC) rescue.

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.

The phosphodiesterase type 5 (PDE5) inhibitor tadalafil (Cialis - Lilly) is now being promoted for once daily treatment of erectile dysfunction. Tadalafil differs from sildenafil (Viagra) and vardenafil (Levitra), the other PDE5 inhibitors marketed for erectile dysfunction in the US, in having a much longer duration of action.

In recent months, both the lay media and some medical experts have raised concerns about the effectiveness and safety of ezetimibe, a widely used drug that prevents absorption of cholesterol from the GI tract. Ezetimibe is available alone as Zetia and in combination with 10, 20, 40 and 80 mg of simvastatin (Zocor, and others) as Vytorin.

Rotigotine (Neupro - Schwarz Pharma), a nonergot dopamine agonist in a transdermal patch formulation, was recently approved by the FDA for treatment of early Parkinson's disease (PD).

Sirolimus, whlch is structurally related to tacrolimus, has been approved by the FDA for prevention of acute renal transplant rejection. The manufacturer recommends that sirolimus be taken with cyclosporine and corticosteroids.

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Colesevelam hydrochloride (Welchol - Sankyo Pharma), a nonabsorbed hydrophilic polymer that binds bile acids, has been approved by the FDA for reduction of plasma LDL cholesterol in patients with primary hypercholesterolemia.