Femcon Fe (Warner Chilcott) is being advertised as the world's only chewable oral contraceptive. It was formerly marketed as Ovcon 35 Fe. Each packet provides 21 tablets containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol, and 7 tablets with only 75 mg of ferrous fumarate. Femcon Fe has the same active hormonal ingredients as Ovcon 35 (Warner Chilcott), which has been available since 1976, and its generic equivalent Balziva (Barr); neither formulation contains iron. The spearmint-flavored Femcon Fe pill can be chewed or swallowed whole. According to the package labeling, if the pill...

The FDA has approved a new formulation of dexrazoxane (Totect) for treatment of extravasation from intravenous (IV) anthracyclines such as doxorubicin (Adriamycin, and others). Dexrazoxane has been available since 1995 as Zinecard for protection against the cardiac toxicity of anthracyclines (Med Lett Drugs Ther 1995; 37:110). It is also available generically. The drug’s precise mechanism of action is not known, but anthracyclines are vesicants that bind to DNA and act as oxidizing agents in the presence of iron. Dexrazoxane is a topoisomerase inhibitor, possibly interfering with...

When the nicotine receptor partial agonist varenicline (Chantix – Pfizer) was first marketed, The Medical Letter concluded that it was moderately effective in increasing smoking cessation rates.1 More recent publications and the clinical experience of Medical Letter consultants now suggest that varenicline is the most effective drug available for this indication, more effective than nicotine replacement therapy or bupropion SR (Zyban).2,3 A word of caution: exacerbations of psychiatric illness have been reported in patients who took higher-than-recommended starting doses of varenicline.4,5...

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

Advertisements for atorvastatin (Lipitor), the market leader facing generic competition, have been in the news recently in the US. Lovastatin, pravastatin and simvastatin are all available generically at a much lower retail price or lower co-pay than atorvastatin.

Mirtazapine (mir taz a peen; Remeron - Organon) has been approved by the US Food and Drug Administration for treatment of depression. A tetracyclic piperazinoazepine, it is an analog of mianserin, an antidepressant available in Europe, but is structurally unrelated to antidepressants previously available in the USA.

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...

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

Linezolid, the first of a new class of antibiotics, the oxazolidinones, has been marketed for treatment of infection due to vancomycin-resistant Enterococcus faecium, nosocomial and community-acquired pueumonia due to Staphylococcus aureus or penicillin-sucsceptible Streptococcus pneumoniae, and skin and skin structure infections, including those due to methicillin-resistant S. aureus (MRSA).