Everolimus (Afinitor – Novartis) and pazopanib (Votrient – GlaxoSmithKline), two oral multikinase inhibitors, have been approved by the FDA for treatment of advanced renal cell carcinoma. Sunitinib (Sutent) and sorafenib (Nexavar), two other oral multikinase inhibitors, and temsirolimus (Torisel), an IV multikinase inhibitor, were approved earlier for the same indication.

The FDA has approved the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (Nesina – Takeda) for treatment of type 2 diabetes. In addition to the single-ingredient product, the FDA also approved fixed-dose combinations of alogliptin/metformin (Kazano) and alogliptin/pioglitazone (Oseni) for the same indication. Alogliptin is the fourth DPP-4 inhibitor to become available in the US. The other three – saxagliptin (Onglyza), sitagliptin (Januvia), and linagliptin (Tradjenta) – are also available in fixed-dose combinations with metformin.

Darbepoetin alfa (Aranesp) has been approved by the FDA for treatment of anemia caused by chronic renal disease and will probably also be approved for use in patients with cancer..

Valdecoxib (Bextra - Pharmacia/Pfizer), a selective cyclooxygenase (COX-2) inhibitor similar to celecoxib (Celebrex) and rofecoxib (Vioxx), was recently approved by the FDA for treatment of osteoarthritis, rheumatoid arthritis and primary dysmenorrhea.

The FDA recently announced that it will permit reintroduction of alosetron hydrochloride (Lotronex - GlaxoSmithKline) for treatment of irritable bowel syndrome (IBS). The drug was previously withdrawn from the market because of severe gastrointestinal toxicity. The reintroduced drug will have a 50% lower starting dose, a narrower indication and some other marketing restrictions (www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm).

Oxaliplatin (Eloxatin -Sanofi-Synthelabo) has been approved by the FDA for use in combination with fluorouracil (5-FU; Adrucil, and others) and leucovorin (LV; Wellcovorin) for patients with metastatic colorectal cancer whose disease has recurred or progressed despite treatment with 5-FU/LV plus irinotecan (Camptosar - Medical Letter 1997; 39:8).

The July 2003 edition of the Canadian Adverse Reaction Newsletter, published by Health Canada (the Canadian FDA), reported that the Health Canada database had received more spontaneous reports of hypoglycemia (19) and hyperglycemia (7) with gatifloxacin (Tequin) than with other quinolone antibiotics.

Continued use of a long-acting beta-2 agonist for treatment of asthma may cause down-regulation of the beta-2 receptor with loss of the bronchoprotective effect from rescue therapy with a short-acting beta-2 agonist. After a large study (SMART) found an increased risk of asthma-related deaths in patients receiving the long-acting beta-2 agonist salmeterol, a boxed warning was added to the labeling of all medications containing a long-acting beta-2 agonist. Now the FDA has completed a meta-analysis of 110 asthma treatment studies in 60,954 patients taking any of the long-acting beta-2 agonist...

Since publication of our recent article on antiviral drugs for influenza, increased levels of resistance to oseltamivir (Tamiflu) have been detected in influenza A H1N1 strains.

Effective treatment of hypertension can prevent organ damage and death. The choice of drugs for initial treatment continues to be controversial.