The Medical Letter - 2022
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August 8, 2022 (Issue 1656)
- COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent...
- COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only) The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6...
- COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only) The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
- Tapinarof Cream (Vtama) for Psoriasis The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to...
- Oteseconazole (Vivjoa) for Recurrent Vulvovaginal Candidiasis The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole...
- Lumateperone (Caplyta) for Bipolar Depression The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use...
- A Donepezil Patch (Adlarity) for Alzheimer's Disease (online only) A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD)...
July 25, 2022 (Issue 1655)
- Drugs for Treatment and Prevention of Venous Thromboembolism Anticoagulants are the drugs of choice for treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE). US guidelines...
- Comparison Table: Some Parenteral Anticoagulants for VTE (online only) View the Comparison Table: Some Parenteral Anticoagulants for VTE
- Comparison Table: Some Oral Anticoagulants for VTE (online only) View the Comparison Table: Some Oral Anticoagulants for VTE
July 11, 2022 (Issue 1654)
- Tirzepatide (Mounjaro) for Type 2 Diabetes The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve...
- Daridorexant (Quviviq) for Insomnia The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin...
- COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as...
- COVID-19 Update: Hypersensitivity Reactions with Tixagevimab/Cilgavimab (Evusheld) The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now...
June 27, 2022 (Issue 1653)
- Drugs for Sexually Transmitted Infections This article includes recommendations for management of most sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been...
June 13, 2022 (Issue 1652)
- Mavacamten (Camzyos) for Obstructive Hypertrophic Cardiomyopathy The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III...
- Tenapanor (Ibsrela) for Irritable Bowel Syndrome with Constipation The FDA has approved tenapanor (Ibsrela - Ardelyx), a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for twice-daily oral treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor...
- COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who...
- COVID-19 Update: FDA Narrows EUA for the Johnson & Johnson Vaccine The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19...
- COVID-19 Update: NIH Recommends Against Ivermectin On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled...
- COVID-19 Update: Remdesivir (Veklury) FDA-Approved for Children <12 Years Old (online only) IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe...
- COVID-19 Update: Baricitinib (Olumiant) FDA-Approved for Treatment of COVID-19 (online only) The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal...
May 30, 2022 (Issue 1651)
- Drugs and Devices for Weight Management Adults with a body mass index (BMI) between 25 and 29.9 kg/m2 are considered overweight. Those with a BMI ≥30 are considered obese. The initial recommendation for any weight loss effort is to achieve a...
- Comparison Table: Some FDA-Approved Drugs for Weight Management (online only) View the Comparison Table: Some FDA-Approved Drugs for Weight Management
May 16, 2022 (Issue 1650)
- A Three-Antigen Hepatitis B Vaccine (PreHevbrio) The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It...
- Tretinoin/Benzoyl Peroxide Cream (Twyneo) for Acne The FDA has approved Twyneo (Galderma), a cream containing the retinoid tretinoin and the oxidizing agent benzoyl peroxide, for once-daily topical treatment of acne in patients ≥9 years...
- Delayed-Release Budesonide (Tarpeyo) for Primary Immunoglobulin A Nephropathy The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN;...
- In Brief: OTC Alcaftadine (Lastacaft Once Daily Relief) for Allergic Conjunctivitis The ophthalmic H1-antihistamine alcaftadine 0.25%, which has been available by prescription since 2011 for use in patients with allergic conjunctivitis, is now available without a prescription as Lastacaft...
- In Brief: Higher-Dose Semaglutide (Ozempic) for Type 2 Diabetes The FDA has approved a higher-dose injectable formulation of the long-acting glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic) for treatment of type 2 diabetes in adults. A single SC...
- Addendum: Dexlansoprazole for GERD A reader commented that our recent article on Drugs for GERD and Peptic Ulcer Disease did not include enough information on dexlansoprazole (Dexilant, and generics), a proton pump inhibitor (PPI) claimed to...
May 2, 2022 (Issue 1649)
- Drugs for Benign Prostatic Hyperplasia About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to...
- Vazalore - A New Aspirin Formulation The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast,...
- A Ranibizumab Ocular Implant (Susvimo) for Age-Related Macular Degeneration The FDA has approved Susvimo (Genentech), a refillable permanent ocular implant containing the vascular endothelial growth factor (VEGF) inhibitor ranibizumab, for treatment of neovascular (wet)...
April 18, 2022 (Issue 1648)
- In Brief: Expanded Heart Failure Indication for Empagliflozin (Jardiance) The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim) was approved by the FDA in 2021 to reduce the risk of hospitalization for heart failure (HF)...
- Tramadol/Celecoxib (Seglentis) for Pain The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a...
- A Drug-Eluting Contact Lens for Allergic Conjunctivitis The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H1-antihistamine ketotifen,...
- Zimhi - A Higher-Dose Injectable Naloxone for Opioid Overdose The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation...
- Efgartigimod alfa (Vyvgart) for Myasthenia Gravis Efgartigimod alfa-fcab (Vyvgart – Argenx), a first-in-class neonatal Fc receptor (FcRn) antagonist, has been approved by the FDA for IV treatment of generalized myasthenia gravis in adults who...
- COVID-19 Updates The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose...
April 4, 2022 (Issue 1647)
- Drugs for GERD and Peptic Ulcer Disease Gastroesophageal reflux disease (GERD) is the most common GI condition encountered in the outpatient setting; it affects about 20% of people in the US.
- Comparison Table: H2-Receptor Antagonists and PPIs (online only) View the Comparison Table: H2-Receptor Antagonists and PPIs
March 21, 2022 (Issue 1646)
- An EUA for Bebtelovimab for Treatment of COVID-19 The investigational monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of mild to moderate COVID-19 in patients ≥12 years...
- Inclisiran (Leqvio) for LDL-Cholesterol Lowering The FDA has approved inclisiran (Leqvio – Novartis), a small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA, as an adjunct to diet and maximally tolerated...
- Faricimab (Vabysmo) for Age-Related Macular Degeneration and Diabetic Macular Edema Faricimab-svoa (Vabysmo – Genentech), an inhibitor of both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), has been approved by the FDA for intravitreal treatment of...
- COVID-19 Updates The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product...
March 7, 2022 (Issue 1645)
- Nonopioid Drugs for Pain Nonopioid drugs can be used in the treatment of many nociceptive and neuropathic pain conditions. For severe pain, especially severe chronic cancer pain, use of opioids may be necessary....
- Comparison Table: Some Nonopioid Analgesics for Pain (online only) View the Comparison Table: Some Nonopioid Analgesics for Pain
February 21, 2022 (Issue 1644)
- Tezepelumab (Tezspire) for Severe Asthma Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma...
- Remimazolam (Byfavo) for Short-Term Procedural Sedation The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes'...
- Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis-Associated Pruritus Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial...
- Cabotegravir (Apretude) for HIV-1 Pre-Exposure Prophylaxis The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually...
- COVID-19 Updates The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to...
February 7, 2022 (Issue 1643)
- Vuity - Pilocarpine Ophthalmic Solution for Presbyopia The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic...
- Difelikefalin (Korsuva) for Chronic Kidney Disease-Associated Pruritus Difelikefalin (Korsuva – Vifor), an IV kappa opioid receptor (KOR) agonist, has been approved by the FDA for treatment of moderate to severe pruritus associated with chronic kidney disease (CKD) in adults...
- Lonapegsomatropin (Skytrofa) for Growth Hormone Deficiency Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due...
- Drugs for Acute Otitis Media in Children More antibiotics are prescribed for treatment of acute otitis media (AOM) than for any other infection in young children. Children with AOM typically present with otalgia, fever, and bulging and erythema of...
- Glycopyrrolate (Dartisla ODT) for Peptic Ulcer Symptoms The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic...
- Treatment of COVID-19 in High-Risk Outpatients (online only) View the Treatment of COVID-19 in High-Risk Outpatients Chart
January 24, 2022 (Issue 1642)
- Paxlovid for Treatment of COVID-19 On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer)...
- Molnupiravir - An Oral Antiviral Drug for COVID-19 The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in...
- In Brief: Mifepristone by Mail for Pregnancy Termination The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and...
- Ruxolitinib (Opzelura) for Atopic Dermatitis The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic...
- Bupivacaine/Meloxicam (Zynrelef) for Postsurgical Pain The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef –...
- COVID-19 Updates On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody...
January 10, 2022 (Issue 1641)
- Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19 The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by...
- Antiviral Drugs for Influenza for 2021-2022 Influenza is generally a self-limited illness, but complications such as pneumonia, respiratory failure, and death can occur, especially in patients at higher risk for complications (see Table 1). Antiviral...
- In Brief: Twice-Yearly Paliperidone (Invega Hafyera) for Schizophrenia Invega Hafyera (Janssen), a long-acting, extended-release (ER) formulation of the second-generation antipsychotic paliperidone palmitate, has been approved by the FDA for twice-yearly IM treatment of...
- Comparison Chart: Antiviral Drugs for Influenza for 2021-2022 (online only) View the Comparison Chart: Antiviral Drugs for Influenza for 2021-2022