Table of Contents - The Medical Letter 2012
January 9, 2012 (Issue 1381)
- Antiviral Drugs for Influenza p. 1
Superseded by The Medical Letter "Antiviral Drugs for Influenza 2012-2013" - Issue 1405, December 10, 2012
Antiviral drugs can be used for treatment and... - Vandetanib (Caprelsa) for Medullary Thyroid Cancer p. 3
The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC)... - In Brief: Ezetimibe/Simvastatin (Vytorin) in Chronic Kidney Disease p. 4
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with...
January 23, 2012 (Issue 1382)
- In Brief: Aliskiren Trial Terminated p. 5
A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE)... - Epidural Corticosteroid Injections for Lumbar and Cervical Radiculopathy p. 5
For patients with radicular pain unresponsive to conservative treatment after 1-2 months and no progressive neurologic deficit, epidural corticosteroid injections are often... - Beta-Adrenergic Blockers and Breast Cancer p. 6
Three retrospective studies have recently reported an association between beta-blocker use and a reduction in breast cancer metastasis and recurrence. No prospective,... - Intranasal Ketorolac (Sprix) p. 7
An intranasal formulation of ketorolac tromethamine (Sprix – Lutipold) has been approved by the FDA for short-term (up to 5 days) treatment of moderate to...
February 6, 2012 (Issue 1383)
- Aflibercept (Eylea) for Age-Related Macular Degeneration p. 9
The FDA has approved aflibercept (a flib’ er sept; Eylea – Regeneron) for treatment of neovascular (wet) age-related macular degeneration (AMD). - PDE5 Inhibitors for Erectile Dysfunction p. 10
Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head... - Crizotinib (Xalkori) for Non-Small Cell Lung Cancer p. 11
The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer... - In Brief: Etonogestrel (Nexplanon) Contraceptive Implant p. 12
Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the...
February 20, 2012 (Issue 1384)
- Salt Restriction p. 13
The average daily intake of sodium in the US is about 3400 mg. Dietary guidelines recommend reducing it to <2300 mg/day in general, and to 1500 mg for African Americans,... - Zolpidem Oral Spray (Zolpimist) for Insomnia p. 14
Zolpidem oral spray (Zolpimist – NovaDel/ECR), a new formulation of the oral hypnotic zolpidem tartrate (Ambien, and others), has been approved by the FDA for... - Deferiprone (Ferriprox) for Iron Overload p. 15
The FDA has approved deferiprone (de fer’ i prone; Ferriprox– ApoPharma), an oral chelating agent available in Europe since 1999, for use as a... - In Brief: 5-HTP for Depression p. 16
A Medical Letter reader asked about the use of the nutritional supplement 5-hydroxytryptophan (5-HTP) for treatment of depression. It is sold in health food stores, pharmacies...
March 5, 2012 (Issue 1385)
- Edarbyclor: An ARB/Chlorthalidone Combination for Hypertension p. 17
The FDA has approved a fixed-dose combination of the angiotensin receptor blocker (ARB) azilsartan and the thiazide-like diuretic chlorthalidone as Edarbyclor (Takeda)... - Clobazam (Onfi) for Lennox-Gastaut Syndrome p. 18
Clobazam (Onfi – Lundbeck), an oral benzodiazepine, has been approved by the FDA for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in... - Glucarpidase (Voraxaze) for Methotrexate Toxicity p. 19
The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with... - In Brief: Immediate-Release Oxycodone (Oxecta) for Pain p. 20
The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe...
March 19, 2012 (Issue 1386)
- Statin Label Changes p. 21
Citing some recent reports, the FDA has announced changes in the safety labeling of all HMG-CoA reductase inhibitors (statins). - Extended-Release Exenatide (Bydureon) for Type 2 Diabetes p. 21
The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for... - Nitroglycerin Ointment (Rectiv) for Anal Fissure p. 23
The FDA has approved the use of nitroglycerin ointment 0.4% (Rectiv – ProStrakan/Aptalis) for treatment of moderate to severe pain associated with chronic anal... - Clarification: Vitamin E p. 24
The recent Medical Letter article on vitamin supplements1 included 2 sentences on vitamin E that could be misleading. "Vitamin E in food, which is mostly...
April 2, 2012 (Issue 1387)
- Low-Dose Sublingual Zolpidem (Intermezzo) for Insomnia due to Middle-of-the-Night Awakening p. 25
The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for... - Bupivacaine Liposome Injection (Exparel) for Postsurgical Pain p. 26
The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of... - Ruxolitinib (Jakafi) for Myelofibrosis p. 27
The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK...
April 16, 2012 (Issue 1388)
- Ivacaftor (Kalydeco) for Cystic Fibrosis p. 29
The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D... - Transcatheter Aortic-Valve Replacement p. 30
Transcatheter aortic-valve replacement (TAVR), a procedure in which a prosthetic valve is inserted into the aortic annulus by a catheter, has been approved by the FDA as an... - Tafluprost (Zioptan) - A New Topical Prostaglandin for Glaucoma p. 31
The FDA has approved tafluprost ophthalmic solution (Zioptan – Merck), a prostaglandin analog, for reduction of intraocular pressure in patients with open-angle... - In Brief: Asparaginase Erwinia chrysanthemi (Erwinaze) for ALL p. 32
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia...
April 30, 2012 (Issue 1389)
- In Brief: Warning about Drospirenone in Oral Contraceptives p. 33
The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be... - Indacaterol (Arcapta Neohaler) for COPD p. 33
The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta2-agonist, for once-daily maintenance... - Ingenol Mebutate (Picato) for Actinic Keratoses p. 35
The FDA has approved ingenol mebutate (Picato – Leo) for topical treatment of actinic keratoses (AKs). The new drug is derived from the sap of the... - Correction: Tafluprost (Zioptan) p. 36
(The Medical Letter 2012; 54:31) In Table 1 on page 31, the formulation column should have included a 0.01% solution of bimatoprost. The size, daily dosage and cost of 0.01%...
May 14, 2012 (Issue 1390)
- Off-Label Use of Ketorolac for Athletic Injuries p. 37
Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into... - Linagliptin/Metformin (Jentadueto) for Type 2 Diabetes p. 37
Linagliptin (Tradjenta) and metformin (Glucophage, and others) are now available as a fixed-dose combination (Jentadueto – Boehringer Ingelheim/Lilly)... - Fentanyl Sublingual Spray (Subsys) for Breakthrough Cancer Pain p. 39
The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and...
May 28, 2012 (Issue 1391)
- Drugs for Menopausal Symptoms p. 41
The primary symptoms of menopause are vasomotor and genitourinary. Vasomotor symptoms ("hot flashes") cause daytime discomfort and chronic insomnia. A thin, dry vaginal... - Choice of Drugs for Heparin-Induced Thrombocytopenia p. 43
A reader has asked us to review the choice of drugs for heparin-induced thrombocytopenia (HIT), a prothrombotic state with high morbidity and mortality. Three...
June 11, 2012 (Issue 1392)
- In Brief: Safety of Azithromycin p. 45
Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase... - Peginesatide (Omontys) for Anemia in Chronic Kidney Disease p. 45
The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for... - Mifepristone (Korlym) for Cushing's Syndrome p. 46
The FDA has approved the antiprogestin mifepristone (Korlym – Corcept Therapeutics) for control of hyperglycemia secondary to hypercortisolism in adults... - Axitinib (Inlyta) for Advanced Renal Cell Carcinoma p. 47
Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior...
June 25, 2012 (Issue 1393)
- Bisphosphonates - Duration of Use Revisited p. 49
Long-term use of bisphosphonates for prevention and treatment of osteoporosis has been associated with osteonecrosis of the jaw, atypical fractures of the femur, and possibly... - Intraosseous Infusion for Rapid Vascular Access p. 50
The intramedullary venous plexus of cancellous bone marrow does not collapse in patients who are dehydrated or in shock. Intraosseous (IO) infusion through an intramedullary... - A New Scorpion Antivenom p. 51
Anascorp (Rare Disease Therapeutics), an intravenously administered antivenom derived from horse serum, has been approved by the FDA for treatment of clinical signs of... - In Brief: Calcium and Vitamin D to Prevent Osteoporotic Fractures p. 52
The US Preventive Services Task Force (USPSTF) has issued a Draft Recommendation Statement saying, in effect, that community-dwelling women and men should not take calcium and...
July 9, 2012 (Issue 1394)
- Vismodegib (Erivedge) for Basal Cell Carcinoma p. 53
The FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal... - An Imaging Agent for Amyloid p. 54
The FDA has approved florbetapir F18 (flor bay´ ta pir; Amyvid – Lilly), an intravenous radioactive diagnostic agent used with positron emission tomography... - Renal Sympathetic Denervation for Hypertension p. 55
Renal sympathetic denervation is under investigation as a therapeutic option for hypertension that has not responded to ≥3 antihypertensive drugs (resistant hypertension). - In Brief: Taliglucerase (Elelyso) for Gaucher Disease p. 56
The FDA has approved taliglucerase alfa (ta lee gloo´ se rays; Elelyso – Pfizer/Protalix), a recombinant form of glucocerebrosidase, for treatment of adults with... - Addendum: Transdermal Estrogen p. 56
A reader commented that our recent article on treatment of menopausal symptoms (Med Lett Drugs Ther 2012; 54:41) should have...
July 23, 2012 (Issue 1395)
- Drugs for Urinary Tract Infections p. 57
The most recent guidelines from the Infectious Diseases Society of America (IDSA) and its European counterpart on the choice of antimicrobials for treatment of uncomplicated... - What Comes After Metformin for Type 2 Diabetes? p. 58
Most experts agree that lifestyle modifications and metformin (Glucophage, and others) should be used first to treat patients with type 2 diabetes. If metformin alone... - Pertuzumab (Perjeta) for HER2-Positive Metastatic Breast Cancer p. 59
Pertuzumab (Perjeta – Roche/Genentech), a humanized monoclonal antibody, has been approved by the FDA for use in combination with trastuzumab (Herceptin)...
August 6, 2012 (Issue 1396)
- PSA Reconsidered p. 61
Three recent publications have focused attention once more on the contentious question of whether men should be screened for prostate cancer by measuring serum concentrations... - Ivermectin (Sklice) Topical Lotion for Head Lice p. 61
The FDA has approved the antiparasitic drug ivermectin in a 0.5% lotion (Sklice – Sanofi Pasteur) as a single-use topical treatment for head lice in patients... - Tablet Splitting p. 63
Breaking drug tablets in half is a common practice. Since our last article on this subject, some new data have become available. - In Brief: Truvada for HIV Prevention p. 63
Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV... - Addendum: What Comes After Metformin for Type 2 Diabetes? p. 64
Several readers have raised questions about the statement in our recent article (Med Lett Drugs Ther 2012; 54:58) that...
August 20, 2012 (Issue 1397)
- Ezogabine (Potiga) for Epilepsy p. 65
The FDA has approved ezogabine (ee-ZOE-ga-been; Potiga – GSK/Valeant) for oral adjunctive treatment of partial-onset seizures in adults. Ezogabine is available in... - Prosthetic Heart Valves p. 67
Prosthetic heart valves have been used effectively in patients with mitral and aortic valvular heart disease for more than 50 years, but no replacement valve developed to... - Addendum: Cost of Drugs for Acute Cystitis p. 67
A reader suggested that our July 23 article on Drugs for Urinary Tract Infection (Med Lett Drugs Ther 2012; 54:57)1... - In Brief: Transdermal Rotigotine (Neupro) p. 68
A patch formulation of the non-ergot dopamine agonist rotigotine (Neupro – UCB) has returned to the US market after a 4-year absence. Originally approved by the FDA...
September 3, 2012 (Issue 1398)
- Two New Drugs for Weight Loss p. 69
The FDA has approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Lorcaserin (lor-ca-SER-in; Belviq... - Citalopram (Celexa) and QT Interval Prolongation p. 71
The FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the...
September 17, 2012 (Issue 1399)
- Prevention and Treatment of Pertussis p. 73
The CDC has reported that many states are experiencing a higher-than-usual incidence of pertussis this year. The highest incidence has been in infants, but the disease has... - Endocarditis Prophylaxis for Dental Procedures p. 74
Since 2007, antimicrobial prophylaxis for dental procedures has been recommended only for patients at highest risk of severe consequences from infective endocarditis. There... - Insect Repellents p. 75
The CDC has received a record number of reports of West Nile virus infection this year – 1993 as of September 4, including 87 deaths – and strongly recommends use of... - Correction: Two New Drugs for Weight Loss p. 76
(Med Lett Drugs Ther 2012; 54:69) On page 71 in the "Drug Interactions" paragraph, the last sentence should read: "Phentermine is...
October 1, 2012 (Issue 1400)
- Influenza Vaccine for 2012-2013 p. 77
Annual vaccination against influenza A and B viruses is the most effective method of preventing influenza and has been shown to decrease influenza illness and its... - Choice of an Oral Anticoagulant in Atrial Fibrillation p. 79
Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one...
October 15, 2012 (Issue 1401)
- Drugs for Hepatitis C p. 81
The CDC is now recommending that everyone in the US born between 1945 and 1965 be tested for hepatitis C virus (HCV) infection. - Fish Oil Supplements p. 83
The FDA has approved 2 products containing omega-3 polyunsaturated fatty acids (PUFAs) for treatment of patients with severe hypertriglyceridemia (>500 mg/dL). Lovaza... - In Brief: Effervescent Alendronate p. 84
A new effervescent formulation of alendronate (Binosto – Mission) was recently approved by the FDA for treatment of osteoporosis. The new 70-mg effervescent tablet is... - Correction: Endocarditis Prophylaxis for Dental Procedures p. 84
(Med Lett Drugs Ther 2012; 54:74) On page 74 in the "Dental Procedures" paragraph, 6th line, the word "rubber" should have been... - In Brief: Two Intranasal Corticosteroid HFA Aerosols for Allergic Rhinitis (online only) p. 84
The FDA has approved 2 intranasal HFA (hydrofluoroalkane) aerosols of the corticosteroids beclomethasone dipropionate (Qnasl – Teva Respiratory) and ciclesonide...
October 29, 2012 (Issue 1402)
- Azelastine/Fluticasone Propionate (Dymista) for Seasonal Allergic Rhinitis p. 85
The FDA has approved a nasal spray fixed-dose combination (Dymista – Meda) of the H1-antihistamine azelastine (Astelin, Astepro, and generics) and... - Pneumococcal Vaccine for Adults p. 87
The US Advisory Committee on Immunization Practices (ACIP) has recommended that adults with immunocompromising conditions receive the 13-valent pneumococcal conjugate vaccine... - In Brief: Budeprion XL 300 Has Been Withdrawn p. 88
The FDA has asked Impax Laboratories/Teva Pharmaceuticals to stop production and distribution of Budeprion XL 300 mg, a generic extended-release formulation of the...
November 12, 2012 (Issue 1403)
- New Drugs for Multiple Sclerosis p. 89
In recent years, several new drugs have been approved by the FDA for use in multiple sclerosis (MS), and many others are in the pipeline. Most recently, teriflunomide... - Linaclotide (Linzess) for Constipation p. 91
Linaclotide (lin´´ a kloe´ tide; Linzess – Ironwood/Forest), a guanylate cyclase-C receptor agonist, was recently approved by the FDA for oral treatment of chronic...
November 26, 2012 (Issue 1404)
- Electronic Cigarettes for Smoking Cessation p. 93
Electronic cigarettes, also called e-cigarettes, are battery-operated nicotine-delivery devices that resemble tobacco cigarettes. They deliver vapor containing a mixture of... - Delayed-Release Prednisone (Rayos) p. 94
The FDA has approved a delayed-release oral formulation of prednisone (Rayos – Horizon Pharma). Rayos is not labeled for any specific indication, but the... - A 4-Drug Combination (Stribild) for HIV p. 95
The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the...
December 10, 2012 (Issue 1405)
- Antiviral Drugs for Influenza 2012-2013 p. 97
Antiviral drugs can be used as an adjunct to vaccination for prophylaxis and treatment of influenza. In recent years, the susceptibility of circulating influenza virus... - Aclidinium Bromide (Tudorza Pressair) for COPD p. 99
The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment...
December 24, 2012 (Issue 1406)
- Cephalosporins for Patients with Penicilllin Allergy p. 101
Only a small minority of patients who say they are allergic to penicillin will have a reaction if they take a penicillin. - Choice of Drug-Eluting Stents p. 102
The use of intracoronary stents in angioplasty procedures has improved both short- and long-term success rates. In recent years, drug-eluting stents (DESs) have largely... - Carfilzomib (Kyprolis) for Multiple Myeloma p. 103
The FDA has approved carfilzomib (Kyprolis – Onyx), a proteasome inhibitor, for intravenous treatment of refractory multiple myeloma. Bortezomib (Velcade) was... - In Brief: Intravenous Ondansetron (Zofran) 32 mg Withdrawn p. 104
The FDA has announced that the single 32-mg IV dose of ondansetron (Zofran, and generics) used for prevention of cancer chemotherapy-associated nausea and vomiting has...
