Treprostinil sodium (tre prost' in il; Remodulin - United Therapeutics), a prostacyclin analogue, has been approved by the FDA for continuous subcutaneous (SC) treatment of patients with pulmonary arterial hypertension who have dyspnea on more than minimal exertion (NYHA Class II-IV).

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).

Aripiprazole (Abilify - Bristol-Myers Squibb/Otsuka), a quinolinone derivative, has been approved by the FDA for treatment of schizophrenia.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

Polycystic ovary syndrome (PCOS), an endocrine abnormality characterized by hyperandrogenism and anovulation, affects 5-10% of women of reproductive age in the US. It is often accompanied by obesity and insulin resistance. In recent years, antidiabetic drugs, although not approved for such use by the FDA, have been tried for treatment of this disorder. This review describes the effectiveness of metformin and the thiazolidinediones in women with PCOS. Also included is a dosage and cost table for some insulin-sensitizing drugs.

Hyperphosphatemia in end-stage renal disease can lead to secondary hyperparathyroidism, renal osteodystrophy, metastatic calcification and cardiovascular mortality. addition to dietary restriction of phosphorus and hemodialysis, drugs that bind phosphates in the gut are usually needed as well. Aluminum hydroxide is no longer recommended for long-term use because of concerns about its toxicity.

The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular Assay (Third Wave Technologies) detects the UGT1A1*28 allele, a variation in the uridine diphosphate glucuronosyltranferase 1A1 (UGT1A1) gene. The FDA recently revised the safety labeling for irinotecan, recommending that the dosing of irinotecan be reduced for patients who are homozygous for the UGT1A1*28 allele.

The FDA has approved an extended-release formulation of minocycline (Solodyn - Medicis) for once-daily treatment of non-nodular moderate to severe acne.

The FDA has approved an oral, fixed-dose combination (Treximet - GlaxoSmithKline) of the selective serotonin receptor agonist ("triptan") sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium (Anaprox, and others) for acute treatment of migraine attacks.

The FDA has approved the marketing of alvimopan (Entereg - Adolor/GlaxoSmithKline), a selective muopioid receptor antagonist, for oral treatment of postoperative ileus after bowel resection. The only other drug in this class available in the US is subcutaneously injected methylnaltrexone (Relistor), which is approved for treatment of opioid-induced constipation in patients with advanced illness receiving palliative care.