The Medical Letter - 2014
Search or Select article below to purchase. Single article price: $45. Order 3 or more at one time and receive a 10% discount.
January 6, 2014 (Issue 1433)
- Simeprevir (Olysio) for Chronic Hepatitis C
The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to... - New Oral Anticoagulants for Acute Venous Thromboembolism
Anticoagulants are the drugs of choice for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE). - In Brief: Khedezla - A New Brand of Desvenlafaxine
The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for...
January 20, 2014 (Issue 1434)
- Sofosbuvir (Sovaldi) for Chronic Hepatitis C
The FDA has approved the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C virus (HCV)... - Antiviral Drugs for Influenza 2013-2014
Superseded by The Medical Letter "Antiviral Drugs for Treatment and Prophylaxis of Seasonal Influenza" - Issue 1563, January 14, 2019Antiviral drugs can be used for treatment of influenza... - In Brief: Ponatinib (Iclusig) Returns
The October 2013 suspension of marketing and sales of ponatinib (Iclusig – Ariad) for treatment of leukemia1 has been lifted by the FDA, and the drug is expected to return to the market...
February 3, 2014 (Issue 1435)
- Perampanel (Fycompa) for Epilepsy
Perampanel (per am’ pa nel; Fycompa – Eisai), a first-in-class noncompetitive AMPA receptor antagonist, has been approved by the FDA for adjunctive treatment of partial-onset seizures... - Certolizumab Pegol (Cimzia) and Ustekinumab (Stelara) for Psoriatic Arthritis
Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara... - In Brief: Rosiglitazone (Avandia) Unbound
The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of... - Addendum: Renal Sympathetic Denervation for Hypertension
Our July 9, 2012 article (Med Lett Drugs Ther 2012; 54:55) on renal sympathetic denervation for multiple-drug resistant hypertension concluded that the catheter-based procedure (Symplicity...
February 17, 2014 (Issue 1436)
- Dapagliflozin (Farxiga) for Type 2 Diabetes
Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment... - Macitentan (Opsumit) for Pulmonary Arterial Hypertension
The FDA has approved macitentan (ma" si ten' tan; Opsumit – Actelion), for oral treatment of pulmonary arterial hypertension (PAH). Macitentan is the second nonselective endothelin...
March 3, 2014 (Issue 1437)
- In Brief: Testosterone and Cardiovascular Risk
Prompted by the recent publication of 2 retrospective studies, the FDA has announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone... - Riociguat (Adempas) for Pulmonary Hypertension
The FDA has approved the sGC stimulator riociguat (rye" oh sig' ue at; Adempas – Bayer) for oral treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary... - Low-Dose Diclofenac (Zorvolex) for Pain
The FDA has approved Zorvolex (Iroko), a low-dose oral formulation of the relatively COX-2 selective NSAID diclofenac, for treatment of mild-to-moderate acute pain in adults.
March 17, 2014 (Issue 1438)
- Mumps Outbreak
An outbreak of mumps has occurred among students at Fordham University in New York. All of those who developed mumps had been vaccinated against the disease. - Intranasal Naloxone for Treatment of Opioid Overdose
The recent increase in deaths from heroin overdose in the US has led to renewed interest in the opioid antagonist naloxone, particularly in making it available as an intranasal spray to... - Drugs for Gout
Superseded by The Medical Letter "Drugs for Gout" - Issue 1567, March 11, 2019The goals of gout treatment are threefold: treating acute inflammation, preventing flares, and lowering...
March 31, 2014 (Issue 1439)
- Golimumab (Simponi) for Ulcerative Colitis
The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in... - A Long-Acting Depot Formulation of Testosterone (Aveed)
The FDA has approved testosterone undecanoate (Aveed – Endo), an injectable depot formulation, for use in men with hypogonadism who require testosterone replacement therapy. - In Brief: Otrexup - A Single-Use Auto-Injector Formulation of Methotrexate
The FDA has approved a new injectable formulation of methotrexate (Otrexup – Antares) for use in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and for severe...
April 14, 2014 (Issue 1440)
- Ibrutinib (Imbruvica) for Chronic Lymphocytic Leukemia
The FDA has approved ibrutinib (eye broo' ti nib; Imbruvica – Janssen/Pharmacyclics), an oral kinase inhibitor, for second-line treatment of chronic lymphocytic leukemia (CLL). It is the... - Anoro Ellipta: An Inhaled Umeclidinium/Vilanterol Combination for COPD
The FDA has approved an inhaled fixed-dose combination of the long-acting anticholinergic umeclidinium (ue mek" li din' ee um) and the long-acting beta2-adrenergic agonist (LABA)... - Inhaled Loxapine (Adasuve) for Acute Agitation
The FDA has approved an inhalation powder formulation of loxapine (Adasuve – Teva), a first-generation antipsychotic long available in an oral formulation, for treatment of acute...
April 28, 2014 (Issue 1441)
- Conjugated Estrogens/Bazedoxifene (Duavee) for Menopausal Symptoms and Prevention of Osteoporosis
The FDA has approved Duavee (Pfizer), a fixed-dose combination of conjugated estrogens and the new selective estrogen receptor modulator (SERM) bazedoxifene, for treatment of moderate to... - Tasimelteon (Hetlioz) for Non-24-Hour Sleep-Wake Disorder
The FDA has approved the melatonin receptor agonist tasimelteon (Hetlioz – Vanda) for treatment of non-24-hour sleep-wake disorder (non-24), which is common in totally blind persons.... - In Brief: Enteric-Coated Aspirin as an Antiplatelet Drug
One of our readers has suggested that more attention should have been paid to a study comparing the antiplatelet effects of immediate-release and enteric-coated aspirin that appeared in...
May 12, 2014 (Issue 1442)
- Avanafil (Stendra) - Another PDE5 Inhibitor for Erectile Dysfunction
The FDA has approved avanafil (Stendra – Vivus), an oral phosphodiesterase type-5 (PDE5) inhibitor, for treatment of erectile dysfunction. It is the fifth PDE5 inhibitor to be approved... - Drugs for MRSA Skin and Soft-Tissue Infections
Methicillin-resistant Staphylococcus aureus (MRSA), which was traditionally a nosocomially-acquired organism but now frequently occurs in the absence of healthcare exposure, is the...
May 26, 2014 (Issue 1443)
- Apremilast (Otezla) for Psoriatic Arthritis
Apremilast (Otezla – Celgene), an oral phosphodiesterase type-4 (PDE4) inhibitor, has been approved by the FDA for treatment of active psoriatic arthritis in adults. It is the fi rst... - Eslicarbazepine Acetate (Aptiom) for Epilepsy
Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the... - Sorafenib (Nexavar) for Thyroid Cancer
The FDA has approved the use of the oral multikinase inhibitor sorafenib (Nexavar – Bayer) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer... - In Brief: Heptavalent Botulism Antitoxin
The FDA has approved the use of an equine heptavalent botulism antitoxin (BAT, Cangene Corporation). The new antitoxin includes antibodies against all 7 botulinum neurotoxin types (A-G). A...
June 9, 2014 (Issue 1444)
- In Brief: A Naloxone Auto-Injector (Evzio)
A recent Medical Letter article reported renewed interest in the intranasal administration (off-label) of the opioid antagonist naloxone because of an increase in deaths from opioid overdose in the... - Extended-Release Hydrocodone (Zohydro ER) for Pain
The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term... - Sublingual Immunotherapy for Allergic Rhinitis
The FDA has approved 3 allergen extracts for sublingual administration as immunotherapy for allergic rhinitis confirmed by a positive skin test or in vitro testing for pollen-specific IgE... - In Brief: Lowering the Dose of Lunesta
The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended...
June 23, 2014 (Issue 1445)
- Low-Dose Aspirin for Prevention of Preeclampsia
The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have recommended that women at risk for preeclampsia take low-dose aspirin daily... - Luliconazole Cream (Luzu) for Tinea Infections
The FDA has approved luliconazole (Luzu Cream, 1% – Valeant) for treatment of tinea pedis, tinea cruris, and tinea corporis infections. - Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis
The FDA has approved another solution of the aminoglycoside antibiotic tobramycin (Bethkis – Chiesi/Cornerstone) for oral inhalation via a nebulizer for management of cystic fibrosis...
July 7, 2014 (Issue 1446)
- Treatment of Atrial Fibrillation
Superseded by The Medical Letter "Drugs for Atrial Fibrillation" - Issue 1580, September 9, 2019The treatment of atrial fibrillation includes anticoagulation, rate control, and rhythm...
July 21, 2014 (Issue 1447)
- In Brief: Generic Celecoxib
The FDA has authorized two manufacturers (Teva, Mylan) to market generic formulations of celecoxib (Celebrex – Pfizer), the only COX-2 selective inhibitor remaining on the US market.... - Extended-Release Oxycodone and Acetaminophen (Xartemis XR)
The FDA has approved a fixed-dose extended-release formulation of oxycodone and acetaminophen (Xartemis XR – Mallinckrodt) for oral treatment of acute pain severe enough to require an... - Oral Propranolol (Hemangeol) for Infantile Hemangioma
The FDA has approved an oral solution of the nonselective beta-adrenergic blocker propranolol (Hemangeol – Pierre Fabre) for treatment of proliferating infantile hemangiomas. - Ceritinib (Zykadia) for Non-Small Cell Lung Cancer
Ceritinib (Zykadia – Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of patients with anaplastic lymphoma kinase (ALK)-positive... - A Responsive Neurostimulator Device (RNS System) for Epilepsy
The FDA has approved the use of a responsive neurostimulator device (RNS System – NeuroPace) for adjunctive treatment of adults with partial-onset seizures that are not controlled with... - In Brief: Esomeprazole Strontium
The FDA has approved the proton pump inhibitor (PPI) esomeprazole strontium for use in adults for the same indications as esomeprazole magnesium (Nexium): treatment of gastroesophageal... - In Brief: Low-Dose Indomethacin (Tivorbex) for Pain
The same pharmaceutical company (Iroko) that recently marketed low-dose diclofenac (Zorvolex) for treatment of mild to moderate acute pain1 has now received approval from the FDA to market...
August 4, 2014 (Issue 1448)
- Drugs for Inflammatory Bowel Disease
Superseded by The Medical Letter "Drugs for Inflammatory Bowel Disease" - Issue 1550, July 2, 2018Aminosalicylates are effective for induction and maintenance of remission in mild to...
August 18, 2014 (Issue 1449)
- Two New Drugs for Skin and Skin Structure Infections
The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Dalbavancin... - Sucroferric Oxyhydroxide (Velphoro) for Hyperphosphatemia
Most patients with end-stage renal disease develop hyperphosphatemia, which can lead to secondary hyperparathyroidism, vascular calcification, and cardiovascular mortality. The FDA has approved... - Glycerol Phenylbutyrate (Ravicti) for Urea Cycle Disorders
The FDA has approved an oral liquid formulation of glycerol phenylbutyrate (Ravicti – Hyperion) for chronic management of patients ≥2 years old with urea cycle disorders that cannot... - A Transcutaneous Electrical Nerve Stimulation Device (Cefaly) for Migraine Prevention
The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The...
September 1, 2014 (Issue 1450)
- Statins and Diabetes Risk
In 2012, the FDA required manufacturers of HMG-CoA reductase inhibitors (statins) to add a warning to their labels about reports of increased blood glucose and glycosylated hemoglobin (HbA1c)... - Drugs for Osteoarthritis
Many different drugs are used for treatment of osteoarthritis pain, but none of them prevent progression of the disease. Many nonpharmacologic approaches are available as well, including weight... - In Brief: New Polio Vaccination Guidance for Travelers
Wild poliovirus has circulated during the previous 12 months in Cameroon, Equatorial Guinea, Ethiopia, Iraq, Israel (also the West Bank and Gaza), Somalia, and Syria, as well as in those countries...
September 15, 2014 (Issue 1451)
- Vorapaxar (Zontivity) for Prevention of Thrombotic Cardiovascular Events
The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic... - Vedolizumab (Entyvio) for Inflammatory Bowel Disease
The FDA has approved vedolizumab (Entyvio - Takeda), an intravenous integrin receptor antagonist, for treatment of moderate to severe ulcerative colitis or Crohn's disease in adults who... - Efinaconazole Topical Solution (Jublia) for Onychomycosis
The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton... - Miltefosine (Impavido) for Leishmaniasis
The FDA has approved miltefosine (Impavido – Knight Therapeutics), an oral alkylphosphocholine analog, for treatment of visceral, cutaneous, and mucosal leishmaniasis caused by some...
September 29, 2014 (Issue 1452)
- Drugs for Postmenopausal Osteoporosis
Superseded by The Medical Letter "Drugs for Postmenopausal Osteoporosis" - Issue 1536, December 18, 2017US guidelines for the treatment of osteoporosis have been published. The diagnosis of...
October 13, 2014 (Issue 1453)
- Influenza Vaccine for 2014-2015
Superseded by The Medical Letter "Influenza Vaccine for 2019-2020" - Issue 1583, October 21, 2019Annual vaccination against influenza A and B viruses has been shown to decrease influenza... - Empagliflozin (Jardiance) for Diabetes
Empagliflozin (Jardiance – Boehringer Ingelheim/Lilly), an SGLT2 inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. It is the third SGLT2 inhibitor to be... - A Stool DNA Test (Cologuard) for Colorectal Cancer Screening
The FDA has approved Cologuard (Exact Sciences), a stool DNA test, to screen average-risk adults ≥50 years old for colorectal cancer. - Rescheduling of Hydrocodone Combination Products
The Drug Enforcement Administration (DEA) has reclassified all hydrocodone combination products as schedule II controlled substances; they were previously classified as schedule III.... - In Brief: PCV13 for Adults 65 Years and Older
The US Advisory Committee on Immunization Practices (ACIP) now recommends routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), in addition to the...
October 27, 2014 (Issue 1454)
- Antithrombotic Drugs
Antiplatelet drugs are the drugs of choice for prevention and treatment of arterial thrombosis. Anticoagulants are the drugs of choice for prevention and treatment of venous thromboembolism and...
November 10, 2014 (Issue 1455)
- Two New GLP-1 Receptor Agonists for Diabetes
Two new injectable GLP-1 (glucagon-like peptide-1) receptor agonists, dulaglutide (Trulicity [trū li si tee] – Lilly) and albiglutide (Tanzeum [tan' zee um] – GSK), have been... - A Combination of Ledipasvir and Sofosbuvir (Harvoni) for Hepatitis C
The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of... - Contrave - A Combination of Bupropion and Naltrexone for Weight Loss
The FDA has approved a fixed-dose combination of the opioid receptor antagonist naltrexone (ReVia, and others) and the antidepressant and smoking cessation agent bupropion (Wellbutrin... - Obinutuzumab (Gazyva) for Chronic Lymphocytic Leukemia (online only)
Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with... - Pembrolizumab (Keytruda) for Metastatic Melanoma (online only)
The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has...
November 24, 2014 (Issue 1456)
- Vaccines for Travelers
Superseded by The Medical Letter "Vaccines for Travelers" - Issue 1560, November 19, 2018Patients planning to travel to other countries should be up to date on routine immunizations and,...
December 8, 2014 (Issue 1457)
- Antiviral Drugs for Seasonal Influenza 2014-2015
Superseded by The Medical Letter "Antiviral Drugs for Treatment and Prophylaxis of Seasonal Influenza" - Issue 1563, January 14, 2019Antiviral drugs can be used for treatment of... - Two New Drugs for Idiopathic Pulmonary Fibrosis
The FDA has approved 2 oral drugs for treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone (Esbriet) has been available in Europe since 2011 and in Canada since 2012. Nintedanib... - Invokamet and Xigduo XR - Two New Combinations for Type 2 Diabetes
The FDA has approved fixed-dose combinations of metformin with either canagliflozin (Invokamet) or dapagliflozin (Xigduo XR) for treatment of patients with type 2 diabetes not... - Secondary Prevention of Stroke
Recent guidelines from the American Heart Association and American Stroke Association reviewed antithrombotic therapy options for secondary prevention of stroke in patients who have had a stroke... - In Brief: Adding Ezetimibe to a Statin Improves Clinical Outcomes
Combining a statin with another drug that lowers low-density lipoprotein cholesterol (LDL-C), such as colesevelam (Welchol), niacin (Niaspan, and others), or ezetimibe... - In Brief: Topiramate Extended-Release Capsules (Qudexy XR) (online only)
The FDA has approved a new extended-release capsule formulation of topiramate (Qudexy XR – Upsher Smith), which can be opened and sprinkled on food for patients who have difficulty...
December 22, 2014 (Issue 1458)
- Drugs for Rheumatoid Arthritis
Superseded by The Medical Letter "Drugs for Rheumatoid Arthritis" - Issue 1552, July 30, 2018For initial treatment of rheumatoid arthritis, most expert clinicians prescribe a... - 2014 Annual Index (Online Only)
View the 2014 Annual Index