The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings are based on a retrospective study in The New England Journal of Medicine (reviewed previously in The Medical Letter2), which found that among patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong...

Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the...

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 <7%. Metformin is the preferred first-line treatment, but most patients with type 2 diabetes eventually require multidrug therapy and/or insulin to achieve glycemic control.

View the Expanded Table: Some Oral Drugs for Chronic Insomnia

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

The FDA has approved Fortesta (Endo), a topical gel, for testosterone replacement therapy in adult males with hypogonadism. It is classified as a Schedule III controlled substance. Table 1 lists some available testosterone products, including 2 other gels.

The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response...

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 for the prophylaxis of malaria in adults. Krintafel (150-mg tablets; GSK) is indicated for the prevention of relapse (radical cure) of Plasmodium vivax malaria in patients ≥16 years old undergoing treatment for acute P. vivax infection.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.