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...

View the Table: Correct Use of Inhalers for COPD

Many patients ask physicians to help them stop smoking. Since nicotine gum and patches were first marketed (Medical Letter, 26:47, 1984; 34:37, 1992), more data have become available on their effective use, and new formulations of the drug have been developed. Because of its slower rate of absorption, nicotine from gum or patches does not produce the pleasure some people associate with cigarette smoking, but it can relieve the irritability, difficulty in concentrating and other symptoms that occur after withdrawal from smoking.

Since the last Medical Letter article on this subject (volume 25, page 54, 1983), transplantation of various organs has become routine, but problems of supply and demand have persisted. The United Network for Organ Sharing (UNOS), which has contracted with the federal government to maintain a list of patients waiting for transplantation and a registry of patients who have received an organ, reports that 18,251 patients received an organ transplant in 1994, and as of June 1995 more than 40,000 patients were waiting for one.

Two new fluoroquinolone solutions, moxifloxacin 0.5% (Vigamox - Alcon) and gatifloxacin 0.3% (Zymar - Allergan) are now available in the US for ophthalmic use in treatment of bacterial conjunctivitis.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

View the Comparison Table: Some Oral Anticoagulants for VTE

The US Department of Health and Human Services, in conjunction with the US Department of Agriculture, has released the latest update of its Dietary Guidelines (www.health.gov). The emphasis this time is on weight loss through calorie restriction and exercise. A low-fat intake is recommended; a low-carbohydrate diet is not. Fruits, vegetables and whole grains are encouraged. A review of Diet, Drugs and Surgery for Weight Loss appeared in the December 2003 issue of Treatment Guidelines from The Medical Letter.

Our article on Antiviral Drugs for Prophylaxis and Treatment of Influenza (Med Lett Drugs Ther 2005;47:93) mentioned possible use of amantadine (Symmetrel, and others) and rimantadine (Flumadine, and others), but warned that the incidence of resistance has increased substantially. The CDC recently issued a Health Alert (www.cdc.gov) saying that current evidence indicates that a high proportion of circulating influenza A viruses in the US are now resistant to amantadine and rimantadine and they should not be used for this indication, at least this year. Click here to go to this update...

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.