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.

Adalimumab (Humira - Abbott), a tumor necrosis factor alpha (TNF-α) inhibitor, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA). A genetically engineered human IgG1 monoclonal antibody, adalimumab is approved for subcutaneous (SC) injection in adults who have failed at least one disease-modifying anti-rheumatic drug (DMARD), for use either alone or with other DMARDs such as methotrexate (Rheumatrex, and others). Two other TNF-α antagonists, etanercept (Enbrel) and infliximab (Remicade), are already on the market for treatment of RA (Treatment...

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.

Aprepitant (Emend - Merck), the first substance P/neurokinin 1 (NK₁) receptor antagonist to be approved by the FDA, is now available for oral use with corticosteroids and selective serotonin (5-HT₃) receptor antagonists to prevent nausea and vomiting caused by highly emetogenic anticancer drugs such as cisplatin.

Levalbuterol, the R-isomer of the beta-2 adrenergic agonist albuterol, is now available in the US as a metered-dose inhaler (Xopenex HFA - Sepracor) for treatment of asthma in patients ≥ 4 years old. Levalbuterol has been available since 1999 in a nebulizer solution for treatment of bronchospasm in patients ≥ 6 years old.1 Outside the US, albuterol is called salbutamol, and levalbuterol is levosalbutamol.

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 over-the-counter (OTC) sale of the weight-loss drug orlistat (Xenical – Roche)1 as alli (GlaxoSmithKline), to be used in combination with a reduced-calorie, low-fat diet. Orlistat binds to gastric and pancreatic lipases, preventing absorption of about 30% of dietary fat with the 120-mg prescription dose, and 25% with the 60-mg OTC dose. A 16-week controlled trial of the OTC dose (60 mg 3 times daily with meals) in overweight, not obese, patients (average BMI 26.8) on a reduced-calorie, low-fat diet found that patients taking the drug lost 1.15 kg more than those taking...

The FDA has received new reports of serious and life-threatening hypersensitivity reactions to omalizumab (Xolair – Genentech), a monoclonal anti-IgE antibody injected subcutaneously for treatment of asthma (Med Lett Drugs Ther 2003; 45:67), and has added a black-box warning to the package insert.Postmarketing reports submitted to the FDA included 124 reports of anaphylaxis among an estimated 57,300 patients (0.2%) who might have been treated with the drug between June 2003 and December 2006. Anaphylaxis occurred after the first dose of Xolair in 39% of cases, after a 2nd dose in 19%, after...

Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten that occurs in about 1% of the population. The main form of treatment is a lifelong gluten-free diet.

The FDA has approved the marketing of a second fixed-dose combination of extended-release niacin (Niaspan) with a generic statin. Niaspan/simvastatin (Simcor - Abbott) is approved for use in patients with hypercholesterolemia or mixed dyslipidemia (high LDL-cholesterol, low HDL-cholesterol and high serum triglycerides). Niaspan/lovastatin (Advicor) was marketed previously for the same indications.