New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and oral molnupiravir (Lagevrio). Remdesivir is FDA-approved for such use; nirmatrelvir/ritonavir and molnupiravir are available under an FDA Emergency Use Authorization. Because the pivotal clinical trials of these products for outpatient use were conducted in patients who were not vaccinated against COVID-19, some clinicians have questioned whether they can benefit vaccinated...

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

In the CLINICAL STUDIES - Other Cancers paragraph (Med Lett Drugs Ther 2007; 49:35), the dosage in the first line should be 2.5 mg/kg, not 25 mg/kg.

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2 years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.

Implantable cardioverter defibrillators (ICDs) are widely used in patients at risk for sudden cardiac death (SCD) because these devices have been highly successful in terminating life-threatening ventricular arrhythmias and in increasing survival.

A "Dear Colleague" letter from the UK's Committee on Safety of Medicines advised physicians, on the basis of unpublished data, not to use paroxetine (Paxil in the US; Seroxat in the UK) to treat children and adolescents with depression because of possible increased risk of suicidal behavior. This review describes the efficacy and safety of SSRIs in children.

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

The Medical Letter was founded in 1959 by Arthur Kallet, an engineer, and Dr. Harold Aaron, an internist. In 1932, Kallet had written the book 100,000,000 Guinea Pigs, a best-seller that was partly responsible for the Food and Drug Act of 1938, which required for the first time that new drugs show proof of safety. He was the founding director of Consumers Union and started the publication of Consumer Reports. Dr. Aaron, who became the medical director of Consumer Reports, suggested to Kallet that doctors could use a similar publication to evaluate the new drugs that were coming on the market...

The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.