The Medical Letter - 2019
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January 14, 2019 (Issue 1563)
- Antiviral Drugs for Treatment and Prophylaxis of Seasonal 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Superseded by The Medical Letter "Antiviral Drugs for Influenza for 2020-2021" - Issue 1610, November 2, 2020Antiviral drugs can be used for treatment and prophylaxis of seasonal influenza... - Tildrakizumab (Ilumya) - Another IL-23 Antagonist for Psoriasis
Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for... - Dupilumab (Dupixent) for Asthma
The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to... - Symfi, Symfi Lo, and Cimduo for HIV (online only)
The FDA has approved three new once-daily fixed-dose antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the non-nucleoside reverse... - Expanded Table: Antiviral Drugs for Treatment and Prophylaxis of Seasonal Influenza 2018-2019 (online only)
Superseded by The Medical Letter "Comparison Chart: Antiviral Drugs for Influenza (online only)" - Issue 1610, November 2, 2020View the Expanded Table: Antiviral Drugs for Seasonal Influenza
January 28, 2019 (Issue 1564)
- OTC Primatene Mist Returns
The FDA has approved over-the-counter (OTC) sale of inhaled epinephrine (Primatene Mist – Amphastar), a nonselective alpha and beta agonist, for temporary relief of mild symptoms of... - Qbrexza - A Glycopyrronium Cloth for Axillary Hyperhidrosis
Qbrexza (Dermira), a premoistened cloth containing the long-acting anticholinergic drug glycopyrronium, has been approved by the FDA for once-daily topical treatment of excessive underarm... - Plenvu - A Low-Volume PEG-Based Colonoscopy Preparation
The FDA has approved Plenvu (Salix), a polyethylene glycol (PEG)-containing oral powder for reconstitution, for colon cleansing prior to colonoscopy in adults. Plenvu is the first... - Revefenacin (Yupelri) for COPD
The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance... - Aripiprazole with Digital Ingestion Tracking (Abilify MyCite)
Monitoring adherence of psychiatric patients to oral medication may be especially difficult. The FDA has approved Abilify MyCite (Otsuka/Proteus), an aripiprazole tablet with an embedded...
February 11, 2019 (Issue 1565)
- Lipid-Lowering Drugs
Cholesterol management guidelines from the American College of Cardiology/American Heart Association Task Force have recently been published. See Table 1 for a brief summary of their... - Expanded Table: Lipid-Lowering Drugs (online only)
View the Expanded Table: Lipid-Lowering Drugs
February 25, 2019 (Issue 1566)
- An Epinephrine Prefilled Syringe (Symjepi) for Anaphylaxis
The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in... - Cardiovascular Benefits of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Type 2 Diabetes
Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of... - Fostamatinib (Tavalisse) for ITP
The FDA has approved fostamatinib disodium hexahydrate (Tavalisse – Rigel), the first spleen tyrosine kinase (SYK) inhibitor, for oral treatment of thrombocytopenia in adults with... - Oxybutynin for Hot Flashes in Women with Breast Cancer
Interim results of a double-blind, placebo-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency and severity of hot flashes in women with... - Drug Interaction: Opioids and Oral P2Y12 Platelet Inhibitors
The FDA has required manufacturers of the oral P2Y12 platelet inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and... - Elderberry for Influenza
Patients may ask about taking elderberry for prevention and treatment of influenza. Products containing elderberry are promoted for relief of cold and flu symptoms and as an immune system booster.
March 11, 2019 (Issue 1567)
- Drugs for Gout
Drugs for gout reduce the pain and inflammation of acute flares and lower serum urate levels in order to prevent recurrent flares, development of tophi, and joint damage. - Xyosted - A Testosterone Auto-Injector for Hypogonadism
The FDA has approved an auto-injector formulation of testosterone enanthate (Xyosted – Antares Pharma) for once-weekly subcutaneous self-administration in adult males with conditions... - Rifamycin (Aemcolo) for Treatment of Travelers' Diarrhea
The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of... - Expanded Table: Some Drugs for Gout (online only)
View the Expanded Table: Some Drugs for Gout
March 25, 2019 (Issue 1568)
- ZTlido - A New Lidocaine Patch for Postherpetic Neuralgia
A lidocaine 1.8% patch (ZTlido – Scilex) has been approved by the FDA for treatment of pain associated with postherpetic neuralgia (PHN). A lidocaine 5% patch (Lidoderm, and... - Sarecycline (Seysara) - Another Oral Tetracycline for Acne
Sarecycline (Seysara — Allergan), a new oral tetracycline antibiotic, has been approved by the FDA for once-daily treatment of inflammatory lesions of non-nodular moderate to severe acne... - Sulfonamide Cross-Reactivity
A reader has questioned why the label for the COX-2 selective NSAID celecoxib (Celebrex, and generics), which contains a sulfonamide moiety, states that it is contraindicated for use in... - Desmopressin (Nocdurna and Noctiva) for Nocturnal Polyuria
The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal... - In Brief: Erenumab (Aimovig) Hypersensitivity
The FDA has approved changes to the labeling of erenumab-aooe (Aimovig)1, a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) blocker approved in 2018 for...
April 8, 2019 (Issue 1569)
- Drugs for Chronic Heart Failure
Patients with a left ventricular ejection fraction (LVEF) ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF). Patients with a LVEF ≤50% and symptoms of heart... - Esketamine Nasal Spray (Spravato) for Treatment-Resistant Depression
The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults... - Expanded Table: Some Drugs for HFrEF (online only)
Superseded by The Medical Letter "Comparison Table: Some Drugs for HFrEF (online only)" - Issue 1619, March 8, 2021View the Expanded Table: Some Drugs for HFrEF
April 22, 2019 (Issue 1570)
- OTC Drugs for Seasonal Allergies
Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available... - Eravacycline (Xerava) - An IV Tetracycline for Complicated Intra-Abdominal Infections
Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults.... - Ozenoxacin 1% Cream (Xepi) for Impetigo
The FDA has approved a 1% cream formulation of ozenoxacin (Xepi – Cutanea), a nonfluorinated quinolone antibiotic, for treatment of impetigo caused by Staphylococcus aureus or...
May 6, 2019 (Issue 1571)
- Insulins for Type 2 Diabetes
The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration without inducing hypoglycemia; for most patients, the target A1C is... - Brexanolone (Zulresso) for Postpartum Depression
The FDA has approved the GABAA receptor modulator brexanolone (Zulresso – Sage Therapeutics) for IV treatment of postpartum depression (PPD). Brexanolone is the first drug to... - Siponimod (Mayzent) - A New Drug for Multiple Sclerosis
The FDA has approved siponimod (Mayzent – Novartis), a sphingosine 1-phosphate (S1P) receptor modulator, for oral treatment of adults with relapsing forms of multiple sclerosis (MS),... - In Brief: Tegaserod (Zelnorm) Returns
Tegaserod maleate (Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable... - Expanded Table: Some Available Insulins for Type 2 Diabetes (online only)
View the Expanded Table: Some Available Insulins
May 20, 2019 (Issue 1572)
- Inhaled Levodopa (Inbrija) for Parkinson's Disease
The FDA has approved Inbrija (Acorda), an orally inhaled dry-powder formulation of levodopa, for intermittent treatment of "off" episodes in patients with Parkinson's disease (PD) being... - Omadacycline (Nuzyra) - A New Tetracycline Antibiotic
The FDA has approved omadacycline (Nuzyra – Paratek), a semisynthetic tetracycline derivative, for once-daily IV and oral treatment of community-acquired bacterial pneumonia (CAP) and... - Emicizumab (Hemlibra) for Subcutaneous Prophylaxis in Hemophilia A
The FDA has approved emicizumab-kxwh (Hemlibra – Genentech), a subcutaneously injected, factor IXa- and X-directed antibody, for routine prophylaxis to prevent or reduce bleeding... - PrabotulinumtoxinA (Jeuveau) for Frown Lines
The FDA has approved prabotulinumtoxinA-xvfs (Jeuveau – Evolus) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or...
June 3, 2019 (Issue 1573)
- Risankizumab (Skyrizi) for Psoriasis
The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third... - Romosozumab (Evenity) for Postmenopausal Osteoporosis
The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high... - Prucalopride (Motegrity) for Chronic Idiopathic Constipation
The FDA has approved the 5-HT4 receptor agonist prucalopride (Motegrity – Shire) for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride is the only drug currently... - Expanded Table: Some Drugs for Chronic Idiopathic Constipation (online only)
View the Expanded Table: Some Drugs for Chronic Idiopathic Constipation
June 17, 2019 (Issue 1574)
- Drugs for Psoriasis
Mild to moderate psoriasis can be treated with topical drugs or with phototherapy. Patients with moderate to severe disease generally require systemic therapy. - Expanded Table: Some Drugs for Psoriasis (online only)
View the Expanded Table: Some Drugs for Psoriasis
July 1, 2019 (Issue 1575)
- Colorectal Cancer Screening
Most colorectal cancers arise from localized adenomatous polyps in a process that may take 10 years or more. Early detection and removal of a precancerous colonic lesion (polyp) can... - Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms
The FDA has approved Bijuva (TherapeuticsMD), a fixed-dose combination of estradiol and progesterone, for oral treatment of moderate to severe vasomotor symptoms (hot flashes) due to... - Tafenoquine (Arakoda; Krintafel) for Malaria
The oral antimalarial tafenoquine succinate, a long-acting analog of primaquine, has been approved by the FDA in 2 different strengths. Arakoda (100-mg tablets; Sixty Degrees) is indicated... - Correction: Drugs for Chronic Heart Failure
In our Drugs for Chronic Heart Failure article,1 our description of the PARADIGM-HF trial comparing the combination of the ARB valsartan and the neprilysin inhibitor sacubitril (Entresto)... - Expanded Table: Drugs for Malaria Prophylaxis (online only)
View the Expanded Table: Drugs for Prophylaxis of Malaria
July 15, 2019 (Issue 1576)
- Drugs for Smoking Cessation
Smoking tobacco remains the primary preventable cause of death in the US. Smoking cessation often requires both pharmacotherapy and behavioral support. - Benzhydrocodone/Acetaminophen (Apadaz) for Pain
The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to... - Expanded Table: Some Drugs for Smoking Cessation (online only)
View the Expanded Table: Some Drugs for Smoking Cessation
July 29, 2019 (Issue 1577)
- Zolgensma - One-Time Gene Therapy for Spinal Muscular Atrophy
The FDA has approved onasemnogene abeparvovec-xioi (Zolgensma – Avexis), an adeno-associated virus vector-based gene therapy, for one-time IV treatment of children <2 years old who... - Bremelanotide (Vyleesi) for Hypoactive Sexual Desire Disorder
The FDA has approved bremelanotide (Vyleesi – Amag), a melanocortin receptor agonist, for subcutaneous treatment of premenopausal women with acquired, generalized hypoactive sexual... - Cyclosporine 0.09% Solution (Cequa) for Dry Eye Disease
The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a... - Cladribine (Mavenclad) for Multiple Sclerosis
The FDA has approved cladribine (Mavenclad – EMD Serono), a purine antimetabolite, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including... - Addendum: Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms
In our article on Bijuva, the oral fixed-dose combination of estradiol and progesterone (Med Lett Drugs Ther 2019; 61:99), Table 1 should have included single-ingredient oral formulations... - Correction: Plenvu
In our article in issue 1564 on Plenvu for colonoscopy preparation (Med Lett Drugs Ther 2019; 61:11), the comparator drug in the DAYB trial was not Prepopik, but rather...
August 12, 2019 (Issue 1578)
- Drugs for Anxiety Disorders
Anxiety disorders (generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobias) are the most common form of psychiatric illness. They can be treated effectively... - Jornay PM - Evening-Dosed Methylphenidate for ADHD
The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of...
August 26, 2019 (Issue 1579)
- Note: Zolgensma Data Manipulation
On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2... - Insect Repellents
Use of insect repellents is strongly recommended by the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) to prevent infections transmitted by... - Solriamfetol (Sunosi) for Excessive Daytime Sleepiness
The FDA has approved solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS)... - Dolutegravir/Lamivudine (Dovato) - A Two-Drug Complete Regimen for HIV-1 Infection
The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase... - In Brief: Risk of Pulmonary Thromboembolism and Death with Tofacitinib (Xeljanz)
The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an...
September 9, 2019 (Issue 1580)
- Drugs for Atrial Fibrillation
Treatment of atrial fibrillation includes anticoagulation, rate control, and rhythm control. US guidelines were recently updated.
September 23, 2019 (Issue 1581)
- Lefamulin (Xenleta) for Community-Acquired Bacterial Pneumonia
Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in... - Glucagon Nasal Powder (Baqsimi) for Severe Hypoglycemia
The FDA has approved glucagon nasal powder (Baqsimi – Lilly) for treatment of severe hypoglycemia in patients ≥4 years old with diabetes. Baqsimi is the first noninjectable... - Duaklir Pressair: Another LAMA/LABA Inhaler for COPD
The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the... - Qmiiz ODT - An Orally Disintegrating Meloxicam Tablet
The FDA has approved Qmiiz ODT (TerSera), an orally disintegrating tablet formulation of the prescription NSAID meloxicam. Qmiiz ODT, like conventional oral meloxicam tablets... - In Brief: Ezallor Sprinkle - A New Formulation of Rosuvastatin
The lipid-lowering drug rosuvastatin is now available in a sprinkle capsule formulation (Ezallor Sprinkle – Sun Pharma). Rosuvastatin tablets (Crestor, and generics) have been... - Expanded Table: Statins (online only)
View the Expanded Table: Statins
October 7, 2019 (Issue 1582)
- Advice for Travelers
Patients who receive pretravel advice can reduce their risk for many travel-related conditions. Vaccines recommended for travelers are reviewed in a separate issue. - Expanded Table: Antibiotics for Travelers' Diarrhea (online only)
View the Expanded Table: Antibiotics for Travelers' Diarrhea - Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness (online only)
View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness
October 21, 2019 (Issue 1583)
- Influenza Vaccine for 2019-2020
Superseded by The Medical Letter "Influenza Vaccine for 2020-2021" - Issue 1607, September 21, 2020Annual vaccination against influenza A and B viruses is recommended for everyone ≥6... - Oral Semaglutide (Rybelsus) for Type 2 Diabetes
An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes...
November 4, 2019 (Issue 1584)
- Drugs for Type 2 Diabetes
Diet, exercise, and weight loss can improve glycemic control, but almost all patients with type 2 diabetes eventually require drug therapy. Treating to a glycated hemoglobin (A1C) concentration...
November 18, 2019 (Issue 1585)
- Cannabis and Cannabinoids
Cannabis (marijuana) contains more than 60 pharmacologically active cannabinoids; delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the best known. THC is the main... - Upadacitinib (Rinvoq) - A New JAK Inhibitor for Rheumatoid Arthritis
The FDA has approved upadacitinib (Rinvoq – Abbvie), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have... - Turmeric Supplements
Turmeric is a spice derived from the Curcuma longa plant. Dietary supplements and foods containing turmeric are widely promoted for relief of pain and to improve joint mobility, immunity,... - In Brief: A New Glucagon Injection (Gvoke) for Severe Hypoglycemia
The FDA has approved a new formulation of glucagon (Gvoke – Xeris) for subcutaneous treatment of severe hypoglycemia in patients ≥2 years old with diabetes. Conscious patients with...
December 2, 2019 (Issue 1586)
- Drugs for Common Eye Disorders
This issue includes reviews of drugs for glaucoma, age-related macular degeneration (AMD), bacterial conjunctivitis, and dry eye disease. Allergic conjunctivitis is reviewed in a separate issue.
December 16, 2019 (Issue 1587)
- Trifarotene (Aklief) - A New Topical Retinoid for Acne
The FDA has approved trifarotene 0.005% cream (Aklief – Galderma) for topical treatment of acne vulgaris in patients ≥9 years old. Trifarotene is the fourth topical retinoid to be... - Annovera - A New Contraceptive Vaginal Ring
Annovera (TherapeuticsMD), a contraceptive vaginal ring that releases segesterone acetate, a synthetic progestin, and ethinyl estradiol, was approved by the FDA in 2018 and is now... - Letermovir (Prevymis) for CMV Prophylaxis
The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult... - Darolutamide (Nubeqa) for Prostate Cancer
The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the...
December 30, 2019 (Issue 1588)
- Drugs for Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines... - 2019 Annual Index (Online Only)
View the 2019 Annual Index