The Medical Letter - 2012
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January 9, 2012 (Issue 1381)
- Antiviral Drugs for Influenza
Superseded by The Medical Letter "Antiviral Drugs for Influenza for 2020-2021" - Issue 1610, November 2, 2020Antiviral drugs can be used for treatment and prophylaxis of influenza. In recent... - Vandetanib (Caprelsa) for Medullary Thyroid Cancer
The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with... - In Brief: Ezetimibe/Simvastatin (Vytorin) in Chronic Kidney Disease
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who...
January 23, 2012 (Issue 1382)
- In Brief: Aliskiren Trial Terminated
A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or... - Epidural Corticosteroid Injections for Lumbar and Cervical Radiculopathy
For patients with radicular pain unresponsive to conservative treatment after 1-2 months and no progressive neurologic deficit, epidural corticosteroid injections are often tried before surgical... - Beta-Adrenergic Blockers and Breast Cancer
Three retrospective studies have recently reported an association between beta-blocker use and a reduction in breast cancer metastasis and recurrence. No prospective, randomized trials have been... - Intranasal Ketorolac (Sprix)
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 moderately severe pain in...
February 6, 2012 (Issue 1383)
- Aflibercept (Eylea) for Age-Related Macular Degeneration
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
Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head comparisons of these... - Crizotinib (Xalkori) for Non-Small Cell Lung Cancer
The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the... - In Brief: Etonogestrel (Nexplanon) Contraceptive Implant
Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and...
February 20, 2012 (Issue 1384)
- Salt Restriction
The average daily intake of sodium in the US is about 3400 mg. Dietary guidelines recommend reducing it to 50 years old. Salt reduction lowers blood pressure, and lowering blood pressure reduces... - Zolpidem Oral Spray (Zolpimist) for Insomnia
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 short-term treatment... - Deferiprone (Ferriprox) for Iron Overload
The FDA has approved deferiprone (de fer’ i prone; Ferriprox – ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload... - In Brief: 5-HTP for Depression
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 and on-line for many...
March 5, 2012 (Issue 1385)
- Edarbyclor: An ARB/Chlorthalidone Combination for Hypertension
The FDA has approved a fixed-dose combination of the angiotensin receptor blocker (ARB) azilsartan and the thiazide-like diuretic chlorthalidone as Edarbyclor (Takeda) for treatment of... - Clobazam (Onfi) for Lennox-Gastaut Syndrome
Clobazam (Onfi – Lundbeck), an oral benzodiazepine, has been approved by the FDA for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years... - Glucarpidase (Voraxaze) for Methotrexate Toxicity
The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate... - In Brief: Immediate-Release Oxycodone (Oxecta) for Pain
The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe pain.Oxecta uses a...
March 19, 2012 (Issue 1386)
- Statin Label Changes
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
The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2... - Nitroglycerin Ointment (Rectiv) for Anal Fissure
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 fissure; the same drug is... - Clarification: Vitamin E
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 gamma-tocopherol, acts as an antioxidant....
April 2, 2012 (Issue 1387)
- Low-Dose Sublingual Zolpidem (Intermezzo) for Insomnia due to Middle-of-the-Night Awakening
The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due... - Bupivacaine Liposome Injection (Exparel) for Postsurgical Pain
The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of postsurgical pain in adults. - Ruxolitinib (Jakafi) for Myelofibrosis
The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for...
April 16, 2012 (Issue 1388)
- Ivacaftor (Kalydeco) for Cystic Fibrosis
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 mutation, which is found in... - Transcatheter Aortic-Valve Replacement
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 alternative to... - Tafluprost (Zioptan) - A New Topical Prostaglandin for Glaucoma
The FDA has approved tafluprost ophthalmic solution (Zioptan – Merck), a prostaglandin analog, for reduction of intraocular pressure in patients with open-angle glaucoma or ocular... - In Brief: Asparaginase Erwinia chrysanthemi (Erwinaze) for ALL
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia chrysanthemi, for...
April 30, 2012 (Issue 1389)
- In Brief: Warning about Drospirenone in Oral Contraceptives
The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a... - Indacaterol (Arcapta Neohaler) for COPD
The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta2-agonist, for once-daily maintenance treatment of airflow... - Ingenol Mebutate (Picato) for Actinic Keratoses
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 Euphorbia peplus plant, a... - Correction: Tafluprost (Zioptan)
(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% bimatoprost are the same...
May 14, 2012 (Issue 1390)
- Off-Label Use of Ketorolac for Athletic Injuries
Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into injured muscles, has... - Linagliptin/Metformin (Jentadueto) for Type 2 Diabetes
Linagliptin (Tradjenta) and metformin (Glucophage, and others) are now available as a fixed-dose combination (Jentadueto – Boehringer Ingelheim/Lilly) for oral treatment of... - Fentanyl Sublingual Spray (Subsys) for Breakthrough Cancer Pain
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 are tolerant to opioid...
May 28, 2012 (Issue 1391)
- Drugs for Menopausal Symptoms
Superseded by The Medical Letter "Drugs for Menopausal Symptoms" - Issue 1604, August 10, 2020The primary symptoms of menopause are vasomotor and genitourinary. Vasomotor symptoms ("hot... - Choice of Drugs for Heparin-Induced Thrombocytopenia
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 recent publications have made...
June 11, 2012 (Issue 1392)
- In Brief: Safety of Azithromycin
Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase the risk of... - Peginesatide (Omontys) for Anemia in Chronic Kidney Disease
The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for treatment of anemia in patients... - Mifepristone (Korlym) for Cushing's Syndrome
The FDA has approved the antiprogestin mifepristone (Korlym – Corcept Therapeutics) for control of hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s... - Axitinib (Inlyta) for Advanced Renal Cell Carcinoma
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 systemic therapy. It...
June 25, 2012 (Issue 1393)
- Bisphosphonates - Duration of Use Revisited
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 esophageal cancer.... - Intraosseous Infusion for Rapid Vascular Access
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 cannula has... - A New Scorpion Antivenom
Anascorp (Rare Disease Therapeutics), an intravenously administered antivenom derived from horse serum, has been approved by the FDA for treatment of clinical signs of scorpion... - In Brief: Calcium and Vitamin D to Prevent Osteoporotic Fractures
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 vitamin D supplements...
July 9, 2012 (Issue 1394)
- Vismodegib (Erivedge) for Basal Cell Carcinoma
The FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal cell cancer, locally advanced... - An Imaging Agent for Amyloid
The FDA has approved florbetapir F18 (flor bay´ ta pir; Amyvid – Lilly), an intravenous radioactive diagnostic agent used with positron emission tomography (PET) scans, to estimate... - Renal Sympathetic Denervation for Hypertension
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
The FDA has approved taliglucerase alfa (ta lee gloo´ se rays; Elelyso – Pfizer/Protalix), a recombinant form of glucocerebrosidase, for treatment of adults with Type 1 Gaucher disease.... - Addendum: Transdermal Estrogen
A reader commented that our recent article on treatment of menopausal symptoms (Med Lett Drugs Ther 2012; 54:41) should have mentioned the potential advantages of transdermal estrogen. Transdermal...
July 23, 2012 (Issue 1395)
- Drugs for Urinary Tract Infections
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 urinary tract... - What Comes After Metformin for Type 2 Diabetes?
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 fails to control... - Pertuzumab (Perjeta) for HER2-Positive Metastatic Breast Cancer
Pertuzumab (Perjeta – Roche/Genentech), a humanized monoclonal antibody, has been approved by the FDA for use in combination with trastuzumab (Herceptin) and docetaxel...
August 6, 2012 (Issue 1396)
- PSA Reconsidered
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 of prostate specific... - Ivermectin (Sklice) Topical Lotion for Head Lice
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 ≥6 months old. Oral... - Tablet Splitting
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
Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been... - Addendum: What Comes After Metformin for Type 2 Diabetes?
Several readers have raised questions about the statement in our recent article (Med Lett Drugs Ther 2012; 54:58) that long-acting insulins, like metformin and sulfonylureas, have been shown to...
August 20, 2012 (Issue 1397)
- Ezogabine (Potiga) for Epilepsy
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 Europe as retigabine... - Prosthetic Heart Valves
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 date is suitable for all... - Addendum: Cost of Drugs for Acute Cystitis
A reader suggested that our July 23 article on Drugs for Urinary Tract Infection (Med Lett Drugs Ther 2012; 54:57)1 should have included information on the cost of the drugs we... - In Brief: Transdermal Rotigotine (Neupro)
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 in 2007 for treatment...
September 3, 2012 (Issue 1398)
- Two Drugs for Weight Loss
In 2013 the FDA 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 – Arena/Esai)... - Citalopram (Celexa) and QT Interval Prolongation
The FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the drug to include new...
September 17, 2012 (Issue 1399)
- Prevention and Treatment of Pertussis
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 also occurred in older... - Endocarditis Prophylaxis for Dental Procedures
Since 2007, antimicrobial prophylaxis for dental procedures has been recommended only for patients at highest risk of severe consequences from infective endocarditis. There is no indication that... - Insect Repellents
Superseded by The Medical Letter "Insect Repellents" - Issue 1579, August 26, 2019The CDC has received a record number of reports of West Nile virus infection this year – 1993 as... - Correction: Two New Drugs for Weight Loss
(Med Lett Drugs Ther 2012; 54:69) On page 71 in the "Drug Interactions" paragraph, the last sentence should read: "Phentermine is contraindicated while taking, and for 14 days after stopping, a...
October 1, 2012 (Issue 1400)
- Influenza Vaccine for 2012-2013
Superseded by The Medical Letter "Influenza Vaccine for 2020-2021" - Issue 1607, September 21, 2020Annual vaccination against influenza A and B viruses is the most effective method of... - Choice of an Oral Anticoagulant in Atrial Fibrillation
Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one or more of the...
October 15, 2012 (Issue 1401)
- Drugs for Hepatitis C
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
The FDA has approved 2 products containing omega-3 polyunsaturated fatty acids (PUFAs) for treatment of patients with severe hypertriglyceridemia (>500 mg/dL). Lovaza (formerly... - In Brief: Effervescent Alendronate
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 considered... - Correction: Endocarditis Prophylaxis for Dental Procedures
(Med Lett Drugs Ther 2012; 54:74) On page 74 in the "Dental Procedures" paragraph, 6th line, the word "rubber" should have been omitted before the word "bands" because placement of rubber bands does... - In Brief: Two Intranasal Corticosteroid HFA Aerosols for Allergic Rhinitis (online only)
The FDA has approved 2 intranasal HFA (hydrofluoroalkane) aerosols of the corticosteroids beclomethasone dipropionate (Qnasl – Teva Respiratory) and ciclesonide (Zetonna –...
October 29, 2012 (Issue 1402)
- Azelastine/Fluticasone Propionate (Dymista) for Seasonal Allergic Rhinitis
The FDA has approved a nasal spray fixed-dose combination (Dymista – Meda) of the H1-antihistamine azelastine (Astelin, Astepro, and generics) and the corticosteroid... - Pneumococcal Vaccine for Adults
The US Advisory Committee on Immunization Practices (ACIP) has recommended that adults with immunocompromising conditions receive the 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar... - In Brief: Budeprion XL 300 Has Been Withdrawn
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 antidepressant bupropion...
November 12, 2012 (Issue 1403)
- New Drugs for Multiple Sclerosis
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 (Aubagio – Genzyme)... - Linaclotide (Linzess) for Constipation
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
Electronic cigarettes, also called e-cigarettes, are battery-operated nicotine-delivery devices that resemble tobacco cigarettes. They deliver vapor containing a mixture of nicotine and either... - Delayed-Release Prednisone (Rayos)
The FDA has approved a delayed-release oral formulation of prednisone (Rayos – Horizon Pharma). Rayos is not labeled for any specific indication, but the only published studies of... - A 4-Drug Combination (Stribild) for HIV
The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse...
December 10, 2012 (Issue 1405)
- Antiviral Drugs for Influenza 2012-2013
Superseded by The Medical Letter "Antiviral Drugs for Influenza for 2020-2021" - Issue 1610, November 2, 2020Antiviral drugs can be used as an adjunct to vaccination for prophylaxis and... - Aclidinium Bromide (Tudorza Pressair) for COPD
The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with...
December 24, 2012 (Issue 1406)
- Cephalosporins for Patients with Penicillin Allergy
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
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 replaced bare-metal stents... - Carfilzomib (Kyprolis) for Multiple Myeloma
The FDA has approved carfilzomib (Kyprolis – Onyx), a proteasome inhibitor, for intravenous treatment of refractory multiple myeloma. Bortezomib (Velcade) was the first proteasome... - In Brief: Intravenous Ondansetron (Zofran) 32 mg Withdrawn
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 been withdrawn from... - 2012 Annual Index (Online Only)
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