Table of Contents - The Medical Letter 2013
January 7, 2013 (Issue 1407)
- Tofacitinib (Xeljanz) for Rheumatoid Arthritis p. 1
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... - Probiotics Revisited p. 3
Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication....
January 21, 2013 (Issue 1408)
- FDA Requires Lower Dosing of Zolpidem p. 5
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,... - Colonoscopy Preparations p. 6
Colonoscopy remains the preferred method of colorectal cancer screening. Many patients consider cleansing the bowel in preparation for colonoscopy the most unpleasant part of... - In Brief: Absorica for Acne p. 8
The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a... - Correction: A 4-Drug Combination (Stribild) for HIV p. 8
On page 95 in the "Drug Interactions" paragraph (Med Lett Drugs Ther 2012; 54:95), the word "oral" should have been added before...
February 4, 2013 (Issue 1409)
- Apixaban (Eliquis) - A New Oral Anticoagulant for Atrial Fibrillation p. 9
The FDA has approved apixaban (Eliquis – Bristol-Myers Squibb/Pfizer), an oral direct factor Xa inhibitor, for prevention of stroke and systemic embolism in patients... - Quillivant XR - An Extended-Release Oral Suspension of Methylphenidate p. 10
The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of... - In Brief: Two New Seasonal Influenza Vaccines p. 12
Two new trivalent influenza vaccines, Flucelvax (Novartis) and Flublok (Protein Sciences), will soon be available for prevention of seasonal influenza in...
February 18, 2013 (Issue 1410)
- In Brief: Auvi-Q - A New Epinephrine Auto-Injector p. 13
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... - Mirabegron (Myrbetriq) for Overactive Bladder p. 13
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... - Laser Treatment of Onychomycosis p. 15
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... - PPIs and Fracture Risk p. 15
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... - Addendum: Cephalosporins for Patients with Penicillin Allergy p. 16
A reader who took the online continuing medical education (CME) exam for issue 1406 (Med Lett Drugs Ther 2012; 54:101) pointed...
March 4, 2013 (Issue 1411)
- Drugs for Hypertriglyceridemia p. 17
Fibrates, niacin and fish oil are promoted for treatment of hypertriglyceridemia. HMG-CoA reductase inhibitors (statins) can lower elevated serum concentrations... - Misoprostol for Miscarriage p. 19
Misoprostol (Cytotec, and generics), a prostaglandin E1 analog FDA-approved for prevention of NSAID-induced gastric ulcers and, when taken with... - Enzalutamide (Xtandi) for Prostate Cancer (online only) p. 20
The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer...
March 18, 2013 (Issue 1412)
- A New Low-Dose Levonorgestrel-Releasing IUD (Skyla) p. 21
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... - Budesonide (Uceris) for Ulcerative Colitis p. 23
The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to... - Mitomycin Solution (Mitosol) for Glaucoma Surgery p. 24
A topical formulation of the antimetabolite mitomycin (Mitosol – Mobius Therapeutics) has been approved by the FDA for adjunctive use in glaucoma surgery to reduce...
April 1, 2013 (Issue 1413)
- Two New Drugs for Homozygous Familial Hypercholesterolemia p. 25
The FDA has approved mipomersen (Kynamro – Genzyme) and lomitapide (Juxtapid – Aegerion), each in addition to a low-fat diet and other lipid-lowering... - Raxibacumab for Anthrax p. 27
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... - In Brief: FDA Azithromycin Warning p. 28
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...
April 15, 2013 (Issue 1414)
- In Brief: Cancer Risk with Salmon Calcitonin p. 29
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... - Teduglutide Injection (Gattex) for Short Bowel Syndrome p. 29
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... - Botox for Overactive Bladder p. 31
The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate...
April 29, 2013 (Issue 1415)
- Icosapent Ethyl (Vascepa) for Severe Hypertriglyceridemia p. 33
Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment... - Long-Acting Injectable Aripiprazole (Abilify Maintena) for Schizophrenia p. 34
An extended-release injectable formulation of the second-generation antipsychotic aripiprazole (Abilify) has been approved by the FDA (Abilify Maintena –... - Regorafenib (Stivarga) for Metastatic Colorectal Cancer and GIST (online only) p. 36
Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated... - Ziv-Aflibercept (Zaltrap) for Metastatic Colorectal Cancer (online only) p. 36
Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination...
May 13, 2013 (Issue 1416)
- Canagliflozin (Invokana) for Type 2 Diabetes p. 37
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... - Pasireotide (Signifor) for Cushing's Disease p. 39
The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by...
