The Medical Letter - 2020
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January 13, 2020 (Issue 1589)
- Antiviral Drugs for Influenza
Superseded by The Medical Letter "Antiviral Drugs for Influenza for 2020-2021" - Issue 1610, November 2, 2020Influenza is generally a self-limited illness, but pneumonia, respiratory... - Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) for Cystic Fibrosis
The FDA has approved Trikafta (Vertex), a fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators elexacaftor, tezacaftor, and ivacaftor, for... - Corticosteroids in Community-Acquired Pneumonia
Recently updated guidelines from the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) address the use of corticosteroids as an adjunct to antimicrobials... - Expanded Table: Antiviral Drugs for Influenza (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Superseded by The Medical Letter "Comparison Chart: Antiviral Drugs for Influenza (online only)" - Issue 1610, November 2, 2020View the Expanded Table: Antiviral Drugs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 Influenza
January 27, 2020 (Issue 1590)
- Drugs for ADHD
Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder that has been diagnosed in up to 10% of school-age children in the US and frequently persists into... - In Brief: Tafamidis (Vyndaqel; Vyndamax) for Transthyretin Amyloid Cardiomyopathy
The FDA has approved tafamidis, an oral transthyretin stabilizer, in 2 different formulations (see Table 1) for treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)....
February 10, 2020 (Issue 1591)
- Reduction of Cardiovascular Risk with Icosapent Ethyl (Vascepa)
Icosapent ethyl (Vascepa – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA for use as an adjunct to maximally tolerated statin therapy to reduce the... - Drospirenone (Slynd) - A New Progestin-Only Oral Contraceptive
The FDA has approved a progestin-only oral contraceptive ("minipill") containing drospirenone (Slynd – Exeltis). All other progestin-only oral contraceptives available in the US... - Istradefylline (Nourianz) for Parkinson's Disease
The FDA has approved istradefylline (Nourianz — Kyowa Kirin), an oral adenosine A2A receptor antagonist, for use as an adjunct to carbidopa/levodopa in adults with Parkinson's... - Brolucizumab (Beovu) for Age-Related Macular Degeneration
Brolucizumab-dbll (Beovu — Novartis), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA as an intravitreal injection for treatment of neovascular (wet)...
February 24, 2020 (Issue 1592)
- Drugs for Depression
Complete remission of symptoms is the goal of treatment for major depressive disorder; a partial response is associated with an increased risk of relapse. Improvement in symptoms can occur...
March 9, 2020 (Issue 1593)
- Peanut Allergen Powder (Palforzia)
The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut... - Lasmiditan (Reyvow) and Ubrogepant (Ubrelvy) for Acute Treatment of Migraine
Lasmiditan (Reyvow – Lilly), an oral serotonin (5-HT1F) receptor agonist, and ubrogepant (Ubrelvy – Allergan), an oral calcitonin gene-related peptide (CGRP) receptor... - Consensi - A Fixed-Dose Combination of Amlodipine and Celecoxib
Consensi (Coeptis/Burke), a fixed-dose combination of the calcium channel blocker amlodipine (Norvasc, and others) and the COX-2 selective NSAID celecoxib (Celebrex, and... - Addendum: Brolucizumab (Beovu) for Age-Related Macular Degeneration
We reviewed brolucizumab (Beovu – Novartis) for treatment of neovascular (wet) age-related macular degeneration in our February 10 issue. On February 23, the American Society of Retina... - Addendum: Drug Interaction between Opioids and Oral P2Y12 Platelet Inhibitors
Opioids delay gastric emptying and the absorption of many oral drugs, including the P2Y12 inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics),...
March 23, 2020 (Issue 1594)
- Drugs for Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating.IBS is classified according to the... - Table: Safety of Drugs for IBS in Pregnancy and Lactation (online only)
View the Table: Safety of Drugs for IBS in Pregnancy and Lactation - Addendum: Drospirenone (Slynd) - A New Progestin-Only Oral Contraceptive
In our article on Slynd (Med Lett Drugs Ther 2020; 62:18), the drospirenone-only oral contraceptive, we mentioned that drospirenone has antiandrogenic activity that could improve acne and...
April 6, 2020 (Issue 1595)
- Some Drugs for COVID-19
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be... - Two Drugs for Sickle Cell Disease: Crizanlizumab (Adakveo) and Voxelotor (Oxbryta)
The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin... - Bempedoic Acid (Nexletol) for Lowering LDL-Cholesterol
The FDA has approved the oral adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid for use alone (Nexletol – Esperion) and in a fixed-dose combination with the cholesterol... - Intravenous Cetirizine (Quzyttir) for Acute Urticaria
Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6... - Table: Treatments Considered for COVID-19 (online only)
View the Table: Treatments Considered for COVID-19
April 20, 2020 (Issue 1596)
- Drugs for Osteoarthritis
Many different drugs are used for treatment of osteoarthritis pain, but none of them prevent progression of the disease. Nonpharmacologic approaches including weight management, exercise, tai... - Intranasal Diazepam (Valtoco) and Midazolam (Nayzilam) for Seizure Clusters
The FDA has approved nasal spray formulations of the benzodiazepines diazepam (Valtoco — Neurelis) and midazolam (Nayzilam — UCB) for acute treatment of intermittent episodes of...
May 4, 2020 (Issue 1597)
- In Brief: Neuropsychiatric Events with Montelukast
The FDA is requiring stronger warnings in the labeling of the leukotriene receptor antagonist montelukast (Singulair, and generics) about the risk of suicidal behavior and other serious... - Cefiderocol (Fetroja) - A New IV Cephalosporin for Complicated UTI
The FDA has approved cefiderocol (Fetroja – Shionogi), a new IV cephalosporin antibiotic, for treatment of complicated urinary tract infections (UTI) caused by susceptible gram-negative... - Minocycline Foam (Amzeeq) for Acne
The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9... - Rimegepant (Nurtec ODT) for Acute Treatment of Migraine
The FDA has approved an orally disintegrating tablet (ODT) formulation of rimegepant (Nurtec ODT – Biohaven), a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist...
May 18, 2020 (Issue 1598)
- Drugs for Hypertension
Drugs available for treatment of chronic hypertension and their dosages, adverse effects, and costs are listed in the tables. Treatment of hypertensive urgencies and emergencies is not discussed...
June 1, 2020 (Issue 1599)
- In Brief: Respiratory Depression with Gabapentinoids
The FDA has required new warnings in the labels of gabapentin (Neurontin, and others) and pregabalin (Lyrica, Lyrica CR, and generics) about the risk of life-threatening... - Cetirizine Ophthalmic Solution (Zerviate) for Allergic Conjunctivitis
A 0.24% ophthalmic solution of the second-generation H1-antihistamine cetirizine (Zerviate – Eyevance) is now available by prescription for treatment of ocular... - Talicia - A 3-Drug Combination for Helicobacter pylori Infection
The FDA has approved a fixed-dose combination of omeprazole, amoxicillin, and rifabutin (Talicia – RedHill) for treatment of Helicobacter pylori infection in adults.... - Eptinezumab (Vyepti) for Migraine Prevention
The FDA has approved eptinezumab-jjmr (Vyepti – Lundbeck), a calcitonin gene-related peptide (CGRP) antagonist administered IV once every 3 months, for migraine prevention in adults. It... - In Brief: Trijardy XR - A New 3-Drug Combination for Type 2 Diabetes
The FDA has approved Trijardy XR (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin, the dipeptidyl peptidase-4...
June 15, 2020 (Issue 1600)
- Drugs for Atopic Dermatitis
Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early...
June 29, 2020 (Issue 1601)
- Lemborexant (Dayvigo) for Insomnia
The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin... - IV Meloxicam (Anjeso) for Pain
The FDA has approved Anjeso (Baudax Bio), an IV formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for once-daily treatment of moderate to severe pain in adults.... - Dapagliflozin (Farxiga) - A New Indication for Heart Failure
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga), which was initially approved by the FDA for treatment of type 2 diabetes and then to reduce the risk of... - Melatonin for Insomnia in Children
Over-the-counter products containing melatonin are widely used as sleep aids in children and adults.
July 13, 2020 (Issue 1602)
- Drugs for Postmenopausal Osteoporosis
US guidelines recommend pharmacologic therapy for postmenopausal women with a bone density T-score (standard deviation from normal mean values in healthy young women) of -2.5 or below in the... - Comparison Table: Some Drugs for Postmenopausal Osteoporosis (online only)
View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis
July 27, 2020 (Issue 1603)
- Lumateperone (Caplyta) for Schizophrenia
The FDA has approved lumateperone (Caplyta — Intracellular Therapies), an oral second-generation antipsychotic, for once-daily treatment of schizophrenia in adults. It is the 13th... - Durysta - A Bimatoprost Implant for Glaucoma
The FDA has approved an intracameral implant containing the prostaglandin analog bimatoprost (Durysta – Allergan) for reduction of intraocular pressure (IOP) in patients with open-angle... - Drugs Past Their Expiration Date
Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do... - Golodirsen (Vyondys 53) for Duchenne Muscular Dystrophy
Golodirsen (Vyondys 53 — Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in the ~8% of patients...
August 10, 2020 (Issue 1604)
- IV Artesunate for Severe Malaria
Artesunate for injection (Amivas LLC), a semi-synthetic artemisinin derivative, is now approved by the FDA for initial (induction) treatment of severe malaria in children and adults. It has been... - Drugs for Menopausal Symptoms
The primary symptoms of menopause are genitourinary (genitourinary syndrome of menopause; GSM) and vasomotor (VMS). Vulvovaginal atrophy can cause vaginal burning, irritation and dryness,...
August 24, 2020 (Issue 1605)
- Phexxi - A Nonhormonal Contraceptive Gel
The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is... - Ozanimod (Zeposia) for Multiple Sclerosis
The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including... - Cenobamate (Xcopri) for Focal Seizures
The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.
September 7, 2020 (Issue 1606)
- Drugs for COPD
The main goals of treatment for chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, and prevent disease progression. Several... - Comparison Table: Inhaled Short-Acting Bronchodilators for Treatment of COPD (online only)
View the Comparison Table: Inhaled Short-Acting Bronchodilators for Treatment of COPD - Comparison Table: Inhaled Long-Acting Bronchodilators for Treatment of COPD (online only)
View the Comparison Table: Inhaled Long-Acting Bronchodilators for Treatment of COPD - Comparison Table: Inhaled Corticosteroids for Treatment of COPD (online only)
View the Comparison Table: Inhaled Corticosteroids for Treatment of COPD - Table: Correct Use of Inhalers for COPD (online only)
View the Table: Correct Use of Inhalers for COPD
September 21, 2020 (Issue 1607)
- Influenza Vaccine for 2020-2021
Annual vaccination against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication. Vaccination of all eligible persons can reduce the prevalence of... - A New Indication for Esketamine Nasal Spray (Spravato)
Esketamine (Spravato – Janssen), an intranasal N-methyl-D-aspartate (NMDA) receptor antagonist that was previously approved by the FDA for treatmentresistant depression,1 has now been... - In Brief: Canagliflozin and Lower Limb Amputations
The FDA has removed a boxed warning from the labeling of products containing the sodium-glucose co-transporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet, Invokamet... - Inhibitors and Inducers of CYP Enzymes and P-Glycoprotein (online only)
View the Inhibitors and Inducers of CYP Enzymes and P-Glycoprotein tables
October 5, 2020 (Issue 1608)
- Drugs for Migraine
An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine headache without severe nausea or vomiting. A triptan is the drug of choice for treatment of...
October 19, 2020 (Issue 1609)
- Timing of Remdesivir for COVID-19
Remdesivir (Veklury – Gilead), an investigational antiviral drug administered by IV infusion, is now available through an FDA Emergency Use Authorization (EUA) for treatment of COVID-19... - Lyumjev - A New Insulin Lispro for Diabetes
The FDA has approved insulin lispro-aabc (Lyumjev – Lilly), a faster-acting formulation of insulin lispro (Humalog), for treatment of type 1 and type 2 diabetes in adults.... - Caplacizumab (Cablivi) for iTTP
Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and... - Sublingual Apomorphine (Kynmobi) for Parkinson's Disease
The FDA has approved a sublingual fi lm formulation of the nonergot dopamine agonist apomorphine (Kynmobi – Sunovion) for acute, intermittent treatment of "off" episodes in patients with... - Viltolarsen (Viltepso) for Duchenne Muscular Dystrophy
The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have... - Two New Doses of Dulaglutide (Trulicity) for Diabetes
The FDA has approved two additional doses (3 mg and 4.5 mg) of the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide (Trulicity – Lilly) for treatment of type 2 diabetes in...
November 2, 2020 (Issue 1610)
- Antiviral Drugs for Influenza for 2020-2021
Influenza is generally a self-limited illness, but complications such as pneumonia, respiratory failure, and death can occur, especially in patients at increased risk for influenza complications... - Large-Volume, Preservative-Free Albuterol Concentrate
The short-acting beta2-agonist albuterol sulfate has recently become available as a large-volume (20 mL), preservative-free concentrate (albuterol inhalation solution 0.5% – Nephron... - In Brief: New Benzodiazepine Warnings
The FDA now requires boxed warnings in the package inserts of benzodiazepines describing the potential for these drugs to be abused and misused and to cause addiction and physical dependence.... - In Brief: New Warnings on NSAID Use in Pregnancy
The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy... - In Brief: Extended-Release Budesonide (Ortikos) for Crohn's Disease
An oral extended-release formulation of the corticosteroid budesonide (Ortikos – Ferring) is now available for once-daily treatment of mild to moderate active Crohn's disease of the... - Comparison Chart: Antiviral Drugs for Influenza (online only)
View the Comparison Chart: Antiviral Drugs for Influenza
November 16, 2020 (Issue 1611)
- In Brief: Hydrochlorothiazide and Skin Cancer
The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products... - Empagliflozin (Jardiance) for Heart Failure
In a randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) reduced the composite risk of... - Minocycline Foam (Zilxi) for Rosacea
The FDA has approved a 1.5% topical foam formulation of minocycline (Zilxi – Foamix) for treatment of inflammatory lesions of rosacea in adults. It is the only topical minocycline... - Orphengesic Forte - An Old Analgesic Combination Returns
A fixed-dose combination of orphenadrine citrate, aspirin, and caffeine (Orphengesic Forte – Galt; previously available as Norgesic Forte) has been approved as a prescription drug... - Two Drugs for Advanced HER2-Positive Breast Cancer (Enhertu and Tukysa)
The FDA has approved two new drugs for treatment of previously-treated unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer: fam-trastuzumab... - Comparison Chart: SGLT2 Inhibitors (online only)
View the Comparison Chart: SGLT2 Inhibitors
November 30, 2020 (Issue 1612)
- An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19
The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to... - Remdesivir (Veklury) for COVID-19
The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized... - Drugs for Acne
Acne is common among adolescents and young adults, but its prevalence appears to have increased in people of all ages due to prolonged wearing of masks during the COVID-19 pandemic. Guidelines... - In Brief: New Meningococcal Serogroup B Vaccination Recommendations
The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now...
December 14, 2020 (Issue 1613)
- Drugs for Asthma
The goal of asthma treatment is to control symptoms, prevent exacerbations, and maintain normal lung function. Management of acute exacerbations of asthma in the emergency department is... - Some Inhaled Drugs for Treatment of Asthma (online only)
View the table: Some Inhaled Drugs for Treatment of Asthma - Correct Use of Inhalers for Asthma (online only)
View the table: Correct Use of Inhalers for Asthma
December 28, 2020 (Issue 1614)
- An EUA for Casirivimab and Imdevimab for COVID-19
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) to be administered together by... - An EUA for Baricitinib (Olumiant) for COVID-19
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in... - Ofatumumab (Kesimpta) for Multiple Sclerosis
The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) for treatment of adults with relapsing forms of multiple... - IV Amisulpride (Barhemsys) for Postoperative Nausea and Vomiting
The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D2/D3) receptor antagonist, for prevention and treatment of... - Pemigatinib (Pemazyre) for Cholangiocarcinoma (online only)
The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or... - 2020 Annual Index (Online Only)
View the 2020 Annual Index