(Med Lett Drugs Ther 2007; 49:55) The second sentence in the article ("The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.") should have been omitted. It would apply to a Class I device, but the FDA has classified Resperate as a Class II device.

The Medical Letter article (Med Lett Drugs Ther 2007; 49:71) on Low-Dose Transdermal Estrogens said that Elestrin has been marketed in Europe since 1976. Actually it is EstroGel (Ascend Therapeutics), a similar product, that has been available in Europe since 1976.

Some Medical Letter consultants have suggested that our recent article on dermal fillers (Med Lett Drugs Ther 2007; 49:39) should have included stronger warnings about the risk of fillers that are not biodegradable, such as Artefill. The polymethylmethacrylate (PMMA, the same material that makes up Plexiglas) beads in Artefill can over time, even with the best technique, cause foreignbody granulomas and hypertrophic scarring, which may require surgical removal. Granulomas and nodules have been especially frequent when Artefill was injected into the lips. Complications are less likely with...

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...

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...

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...

Recent publicity about symptoms of ovarian cancer will prompt many questions from patients about testing for the disease. Early-stage epithelial ovarian cancer is potentially curable, with survival rates of 90-95%, but about 75% of women have advanced or metastatic disease at diagnosis. Between physical examination and exploratory surgery, 2 tests are commonly used.1Transvaginal ultrasound (TVUS) images the ovaries better than transabdominal ultrasound. In a study in which 25,327 asymptomatic women were screened with TVUS annually from 1987 to 2005, 364 patients had exploratory surgery, and 44...

Some recently published studies suggest that taking selective serotonin reuptake inhibitors (SSRIs) may increase the risk of developing osteoporosis. A relationship between SSRIs and osteoporosis is biologically plausible because bone has serotonin receptors, and SSRI-treated mice have reduced bone mass.

The FDA has approved ThermaClear (Therative), a battery-powered, handheld device, to treat individual acne lesions with heat. ThermaClear is indicated only for use on mild to moderate inflammatory acne, not severe nodular or severe cystic acne, and it is not meant to be used on blackheads and whiteheads. Two similar devices are already on the market: Zeno, another handheld device that delivers heat to acne lesions, and the Radiancy Clear Touch Lite Acne Clearance System, a larger heat-delivery device.