The Medical Letter - 2013
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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)
- Apixaban (Eliquis) - A New Oral Anticoagulant for Atrial Fibrillation
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 with nonvalvular... - Quillivant XR - An Extended-Release Oral Suspension of Methylphenidate
The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the... - In Brief: Two New Seasonal Influenza Vaccines
Two new trivalent influenza vaccines, Flucelvax (Novartis) and Flublok (Protein Sciences), will soon be available for prevention of seasonal influenza in adults ≥18 years old...
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)
- Icosapent Ethyl (Vascepa) for Severe Hypertriglyceridemia
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 of severe... - Long-Acting Injectable Aripiprazole (Abilify Maintena) for Schizophrenia
An extended-release injectable formulation of the second-generation antipsychotic aripiprazole (Abilify) has been approved by the FDA (Abilify Maintena – Otsuka/Lundbeck) for... - Regorafenib (Stivarga) for Metastatic Colorectal Cancer and GIST (online only)
Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other... - Ziv-Aflibercept (Zaltrap) for Metastatic Colorectal Cancer (online only)
Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination with 5-fluorouracil, leucovorin...
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)
- Alogliptin (Nesina) for Type 2 Diabetes
The FDA has approved the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (Nesina – Takeda) for treatment of type 2 diabetes. In addition to the single-ingredient product, the FDA... - Omalizumab (Xolair) for Chronic Urticaria
Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used... - Inhibitors and Inducers of CYP Enzymes and P-glycoprotein (online only)
Superseded by The Medical Letter "Inhibitors and Inducers of CYP Enzymes and P-Glycoprotein (online only)" - Issue 1517, March 27, 2017The tables below list the drugs that induce or inhibit...
June 10, 2013 (Issue 1418)
- In Brief: Warning Against Use of Valproate for Migraine Prevention During Pregnancy
The FDA is advising health care professionals not to prescribe valproate sodium (Depacon), valproic acid (Depakene, Stavzor, and generics) or divalproex sodium (Depakote,... - Dimethyl Fumarate (Tecfidera) for Multiple Sclerosis
The FDA has approved dimethyl fumarate (Tecfidera – Biogen Idec), formerly called BG-12, for treatment of relapsing forms of multiple sclerosis (MS). It is the third oral drug to be... - Lubiprostone (Amitiza) for Opioid-Induced Constipation
The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic...
June 24, 2013 (Issue 1419)
- Liptruzet: A Combination of Ezetimibe and Atorvastatin
The FDA has approved a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe and the HMG-CoA reductase inhibitor (statin) atorvastatin as Liptruzet (Merck) for treatment... - Nutritional Supplements for Age-Related Macular Degeneration Revisited
The results of the Age-Related Eye Disease Study 2 (AREDS2) have now been published. The primary purpose of the study was to evaluate the efficacy and safety of the carotenoids lutein and... - Tobramycin Inhalation Powder (Tobi Podhaler) for Cystic Fibrosis
Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas... - In Brief: Plan B One-Step OTC
The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg...
July 8, 2013 (Issue 1420)
- Kcentra: A 4-Factor Prothrombin Complex Concentrate for Reversal of Warfarin Anticoagulation
The FDA has approved use of Kcentra (CSL Behring), a human-derived 4-factor prothrombin complex concentrate (PCC), for urgent reversal of warfarin anticoagulation in adults with acute... - Quartette: An Ascending-Dose, Extended-Cycle Oral Contraceptive
The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin... - Ospemifene (Osphena) for Dyspareunia
The FDA has approved ospemifene (os pem’ i feen; Osphena – Shionogi), an estrogen agonist/antagonist, for oral treatment of moderate to severe dyspareunia in postmenopausal women....
July 22, 2013 (Issue 1421)
- Brinzolamide/Brimonidine (Simbrinza) for Glaucoma
The FDA has approved Simbrinza (Alcon), an ophthalmic combination of the carbonic anhydrase inhibitor brinzolamide and the selective alpha2-adrenergic receptor agonist... - Citalopram, Escitalopram and the QT Interval
In 2011, the FDA asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) citalopram (Celexa, and generics) to lower the maximum daily dosage of the drug because of a... - Crofelemer (Fulyzaq) for Antiretroviral-Induced Diarrhea
The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for...
August 5, 2013 (Issue 1422)
- Diclegis for Nausea and Vomiting of Pregnancy
The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H1-antihistamine doxylamine and the vitamin B6 analog pyridoxine, for... - Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Metastatic Melanoma
The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and... - Ocriplasmin (Jetrea) for Vitreomacular Adhesion
Ocriplasmin (Jetrea – ThromboGenics) was recently approved by the FDA as an intravitreal injection for treatment of symptomatic vitreomacular adhesion. It is the first drug to be...
August 19, 2013 (Issue 1423)
- Canakinumab (Ilaris) for Systemic Juvenile Idiopathic Arthritis
The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile... - Bedaquiline (Sirturo) for Multidrug-Resistant Tuberculosis
Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs... - In Brief: Nimodipine Oral Solution (Nymalize)
The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after...
September 2, 2013 (Issue 1424)
- Breo Ellipta: An Inhaled Fluticasone/Vilanterol Combination for COPD
The FDA has approved an inhaled fixed-dose combination (Breo Ellipta – GSK/Theravance) of the corticosteroid fluticasone furoate and the long-acting beta2-adrenergic agonist... - Ponatinib (Iclusig) for CML and Ph+ ALL
Ponatinib (Iclusig – Ariad), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) or...
September 16, 2013 (Issue 1425)
- Influenza Vaccine for 2013-2014
Superseded by The Medical Letter "Influenza Vaccine for 2020-2021" - Issue 1607, September 21, 2020Annual 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)
- Deep Brain Stimulation for Parkinson's Disease with Early Motor Complications
Deep brain stimulation is FDA-approved and has been used for years to treat patients with advanced Parkinson's disease (PD) who have severe levodopa-induced motor complications. New evidence from... - Brimonidine Gel (Mirvaso) for Rosacea
The FDA has approved the selective alpha2-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial... - In Brief: Buprenorphine/Naloxone (Zubsolv) for Opioid Dependence
A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance... - Addendum: Ospemifene (Osphena) for Dyspareunia
Some readers have objected to our recommendation (Med Lett Drugs Ther 2013; 55:55) that postmenopausal women with an intact uterus who take the oral estrogen agonist/antagonist ospemifene...
October 28, 2013 (Issue 1428)
- Paroxetine (Brisdelle) for Hot Flashes
The FDA has approved a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle – Noven Therapeutics) for treatment of moderate-to-severe... - Belotero Balance for Wrinkles and Folds
Belotero Balance (Merz), an injectable hyaluronic acid dermal filler, has been approved by the FDA for temporary correction of moderate-to-severe facial wrinkles and folds. Several other... - Topiramate Extended-Release (Trokendi XR) for Epilepsy
The FDA has approved a once-daily extended-release (ER) formulation of the antiepileptic topiramate (Trokendi XR – Supernus) for initial monotherapy in patients ≥10 years old with... - In Brief: Miltefosine for Amebic Meningoencephalitis Available from CDC
The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug...
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)
- In Brief: Ponatinib (Iclusig) Marketing and Sales Suspended
The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk... - Vortioxetine (Trintellix) for Depression
The FDA has approved vortioxetine (vor" tye ox' e teen; Trintellix – Takeda/Lundbeck), a new serotonergic drug, for treatment of major depressive disorder. Like... - Hydrocodone/Chlorpheniramine (Vituz)
An oral solution (Vituz – Hawthorne) containing two old drugs, the centrally-acting opioid hydrocodone bitartrate and the first-generation H1-antihistamine... - In Brief: Ezogabine (Potiga) Toxicity
The FDA recently announced changes in the labeling of ezogabine (Potiga – GSK/Valeant) to warn about the risks of retinal abnormalities, possible vision loss, and bluish skin...
December 9, 2013 (Issue 1431)
- In Brief: Prevention of Meningococcal B Disease
An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational... - MiniMed 530G: An Insulin Pump with Low-Glucose Suspend Automation
The FDA has approved the MiniMed 530G (Medtronic), an insulin pump used in combination with a continuous glucose monitoring sensor (Enlite) that can stop delivery of insulin when... - Pertuzumab (Perjeta) for Preoperative Use in HER2-Positive Breast Cancer
The FDA has approved the neoadjuvant (preoperative) use of pertuzumab (Perjeta – Genentech) in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and... - Ferric Carboxymaltose (Injectafer) for Iron Deficiency Anemia
The FDA has approved ferric carboxymaltose (Injectafer – American Regent), a 2-dose intravenous iron replacement product, for treatment of iron deficiency anemia (IDA) in adults who...
December 23, 2013 (Issue 1432)
- Levomilnacipran (Fetzima): A New SNRI for Depression
The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder.... - TNF Inhibitors for Crohn's Disease: When, Which, and for How Long
Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of... - A Percutaneous Device (MitraClip) for Mitral Regurgitation
The FDA has approved the use of a transcatheter mitral valve device (MitraClip – Abbott) for percutaneous treatment of significant symptomatic degenerative mitral regurgitation (grade... - 2013 Annual Index (Online Only)
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