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The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together by IV infusion or SC injection for treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years old and weigh ≥40 kg) who are at high risk of progressing to severe COVID-19 and/or...
The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
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 hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV...
The Medical Letter on Drugs and Therapeutics • December 3, 2020 (Issue )
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review two requests for Emergency Use Authorization (EUA) of COVID-19 vaccine candidates this month. They will review Pfizer and BioNTech's request on December 10 and Moderna's request on December 17. Both meetings will be webcast from the FDA's website and streamed on Facebook, Twitter, and YouTube.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
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 children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
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 moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).
The Medical Letter on Drugs and Therapeutics • November 16, 2020 (Issue 1611)
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 containing the diuretic hydrochlorothiazide.
The Medical Letter on Drugs and Therapeutics • November 16, 2020 (Issue 1611)
View the Comparison Chart: SGLT2 Inhibitors
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
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 (see Table 1). Antiviral drugs recommended for treatment and chemoprophylaxis of influenza this season are listed in Table 2. Updated information on influenza activity and antiviral resistance is...
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
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 ileum and/or ascending colon in patients ≥8 years old and for maintenance of remission for up to 3 months in adults. Ortikos is the second oral formulation of budesonide to be approved for this...
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
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. Benzodiazepine labels have contained a boxed warning about a risk of serious drug interactions with opioids since 2016.
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
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 beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously...
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
View the Comparison Chart: Antiviral Drugs for Influenza
The Medical Letter on Drugs and Therapeutics • October 19, 2020 (Issue 1609)
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 in all hospitalized patients. An earlier EUA limited use of the drug to patients hospitalized with severe disease.
The Medical Letter on Drugs and Therapeutics • October 19, 2020 (Issue 1609)
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 adults. Dulaglutide has been available in 0.75- and 1.5-mg doses for years.
The Medical Letter on Drugs and Therapeutics • September 21, 2020 (Issue 1607)
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 influenza illness and symptoms that might be confused with those of COVID-19. Available vaccines and recommendations for specific patient populations for the 2020-2021 season are listed in Tables 2 and 3. Lower...
The Medical Letter on Drugs and Therapeutics • September 21, 2020 (Issue 1607)
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 XR) that described an increased risk of lower limb amputation associated with use of the drug. Package inserts for canagliflozin products still contain a standard warning about a risk of lower limb...
The Medical Letter on Drugs and Therapeutics • June 1, 2020 (Issue 1599)
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 or fatal respiratory depression in patients with respiratory risk factors. Respiratory risk factors include chronic obstructive pulmonary disease (COPD) and concurrent use of opioids or other CNS depressants...
The Medical Letter on Drugs and Therapeutics • June 1, 2020 (Issue 1599)
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 (DPP-4) inhibitor linagliptin, and extended-release metformin, for oral treatment of type 2 diabetes in adults. Empagliflozin and linagliptin have been available in a fixed-dose combination as Glyxambi...
The Medical Letter on Drugs and Therapeutics • May 4, 2020 (Issue 1597)
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 neuropsychiatric events associated with its use.