The Medical Letter - 2013
Year:    Publication:      2013 Annual Index: U.S. English | Canadian English
January 7, 2013 (Issue 1407)  
  • Tofacitinib (Xeljanz) for Rheumatoid Arthritis
    The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid...
  • Probiotics Revisited
    Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article...
January 21, 2013 (Issue 1408)  
  • FDA Requires Lower Dosing of Zolpidem
    On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and...
  • Colonoscopy Preparations
    Colonoscopy remains the preferred method of colorectal cancer screening. Many patients consider cleansing the bowel in preparation for colonoscopy the most unpleasant part of the procedure, but...
  • In Brief: Absorica for Acne
    The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product...
  • Correction: A 4-Drug Combination (Stribild) for HIV
    On page 95 in the "Drug Interactions" paragraph (Med Lett Drugs Ther 2012; 54:95), the word "oral" should have been added before "midazolam" in the 3rd sentence. Stribild is contraindicated...
February 4, 2013 (Issue 1409)  
February 18, 2013 (Issue 1410)  
  • In Brief: Auvi-Q - A New Epinephrine Auto-Injector
    A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width...
  • Mirabegron (Myrbetriq) for Overactive Bladder
    Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first...
  • Laser Treatment of Onychomycosis
    Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for...
  • PPIs and Fracture Risk
    Use of proton pump inhibitors (PPIs) to treat gastroesophageal reflux disease (GERD) has been associated with an increase in the risk of fractures. The FDA now requires that the labels of all...
  • Addendum: Cephalosporins for Patients with Penicillin Allergy
    A reader who took the online continuing medical education (CME) exam for issue 1406 (Med Lett Drugs Ther 2012; 54:101) pointed out that the first question assumed that a rash following oral...
March 4, 2013 (Issue 1411)  
  • Drugs for Hypertriglyceridemia
    Fibrates, niacin and fish oil are promoted for treatment of hypertriglyceridemia. HMG-CoA reductase inhibitors (statins) can lower elevated serum concentrations of triglycerides, but less so than...
  • Misoprostol for Miscarriage
    Misoprostol (Cytotec, and generics), a prostaglandin E1 analog FDA-approved for prevention of NSAID-induced gastric ulcers and, when taken with mifepristone (Mifeprex),...
  • Enzalutamide (Xtandi) for Prostate Cancer (online only)
    The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer in patients previously...
March 18, 2013 (Issue 1412)  
  • A New Low-Dose Levonorgestrel-Releasing IUD (Skyla)
    The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table...
  • Budesonide (Uceris) for Ulcerative Colitis
    The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative...
  • Mitomycin Solution (Mitosol) for Glaucoma Surgery
    A topical formulation of the antimetabolite mitomycin (Mitosol – Mobius Therapeutics) has been approved by the FDA for adjunctive use in glaucoma surgery to reduce scarring. Compounding...
April 1, 2013 (Issue 1413)  
  • Two New Drugs for Homozygous Familial Hypercholesterolemia
    The FDA has approved mipomersen (Kynamro – Genzyme) and lomitapide (Juxtapid – Aegerion), each in addition to a low-fat diet and other lipid-lowering medications, to reduce...
  • Raxibacumab for Anthrax
    The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with...
  • In Brief: FDA Azithromycin Warning
    The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac...
April 15, 2013 (Issue 1414)  
  • In Brief: Cancer Risk with Salmon Calcitonin
    Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an...
  • Teduglutide Injection (Gattex) for Short Bowel Syndrome
    The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults...
  • Botox for Overactive Bladder
    The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate...
April 29, 2013 (Issue 1415)  
May 13, 2013 (Issue 1416)  
  • Canagliflozin (Invokana) for Type 2 Diabetes
    Canagliflozin (kan" a gli floe' zin; Invokana – Janssen), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes.
  • Pasireotide (Signifor) for Cushing's Disease
    The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting...
May 27, 2013 (Issue 1417)  
June 10, 2013 (Issue 1418)  
June 24, 2013 (Issue 1419)  
July 8, 2013 (Issue 1420)  
July 22, 2013 (Issue 1421)  
August 5, 2013 (Issue 1422)  
August 19, 2013 (Issue 1423)  
September 2, 2013 (Issue 1424)  
September 16, 2013 (Issue 1425)  
  • Influenza Vaccine for 2013-2014
    Superseded by The Medical Letter "Influenza Vaccine for 2016-2017" - Issue 1505, October 10, 2016Annual vaccination against influenza A and B viruses has been shown to decrease influenza...
  • Ado-Trastuzumab Emtansine (Kadcyla) for HER2-Positive Metastatic Breast Cancer
    Ado-trastuzumab emtansine (Kadcyla – Genentech), a human epidermal growth factor receptor 2 (HER2)-targeted antibody and microtubule inhibitor conjugate, has been approved by the FDA for...
  • In Brief: Oxytrol OTC
    The transdermal patch formulation of the anticholinergic drug oxybutynin (Oxytrol – Watson) is now available over the counter (OTC) as Oxytrol for Women (MSD) for use in women...
September 30, 2013 (Issue 1426)  
  • Rethinking Warfarin for Atrial Fibrillation
    Full-page newspaper advertisements and a series of television commercials have urged patients with atrial fibrillation to "rethink warfarin" in favor of Eliquis (apixaban – Bristol-Myers...
  • Dolutegravir (Tivicay) for HIV
    The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in...
  • Radium-223 (Xofigo) for Prostate Cancer
    Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone...
October 14, 2013 (Issue 1427)  
October 28, 2013 (Issue 1428)  
November 11, 2013 (Issue 1429)  
  • In Brief: Fluoroquinolones and Peripheral Neuropathy
    The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy...
  • Electronic Cigarettes
    Electronic cigarettes, also called e-cigarettes, are advertised as a safer, more convenient, and socially acceptable alternative to smoking tobacco cigarettes. Widely available in retail stores...
  • An OTC Corticosteroid Nasal Spray for Allergic Rhinitis
    The FDA has approved the over-the-counter (OTC) sale of Nasacort Allergy 24HR (Sanofi), a triamcinolone acetonide nasal spray previously available only by prescription as Nasacort...
  • A Prostatic Urethral Lift for Benign Prostatic Hyperplasia
    The FDA has approved the use of a permanent prostatic urethral lift implant (UroLift – NeoTract) to relieve low or blocked urine flow in men ≥50 years old with benign prostatic...
  • In Brief: Meningococcal Vaccine for Infants
    Rates of meningococcal disease are highest in infancy, but until recently no meningococcal vaccine was approved for use in this age group. MenHibrix (GSK), a new conjugate vaccine that...
November 25, 2013 (Issue 1430)  
December 9, 2013 (Issue 1431)  
December 23, 2013 (Issue 1432)