The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

Consumption of alcohol has increased during the COVID-19 pandemic. The Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) defines alcohol use disorder (AUD; previously called alcohol dependence) as meeting ≥2 of the 11 criteria listed in Table 1 in the past year. The lifetime prevalence of AUD in the US population has been estimated to be about 30%. Despite this high prevalence and the associated morbidity, mortality, and costs, only 3 drugs are FDA-approved for treatment of the disorder.

A reader has asked us to review the use of propofol (Diprivan, and others) as a sedative agent for brief procedures, such as colonoscopy.First marketed more than 20 years ago,1 propofol has a rapid onset of action (patients usually lose consciousness in less then one minute) and a short duration of action with a rapid recovery (3-5 minutes) that makes it highly suitable for brief ambulatory procedures. Propofol is now the most commonly used parenteral anesthetic in the US.2 The main problems with its use have been pain on injection and bacterial contamination, both related to its lipid...

The FDA has approved defibrotide sodium (Defitelio – Jazz), a mixture of mostly single-stranded polydeoxyribonucleotide sodium salts, for treatment of adults and children with hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome) and renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is the first drug to be approved by the FDA for treatment of severe hepatic veno-occlusive disease. Defibrotide was approved earlier by the European Medicines Agency for the same indication.Hepatic veno-occlusive disease is an uncommon (<2%)...

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 androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

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Since The Medical Letter last reviewed the choice of benzodiazepines (Volume 23, page 41, 1981), several new drugs have been marketed and some old ones are now available generically. Most of the benzodiazepines available for oral use in the USA are listed in the table on page 28.

Cefuroxime axetil (Ceftin - Glaxo), an oral form of the second-generation parenteral cephalosporin cefuroxime (Zinacef), was recently marketed in the USA. Previously available oral cephalosporins are the first-generation drugs cephalexin (Keflex; and others), cephradine (Anspor; and others) and cefadroxil (Duricef; and others), and the second-generation cefaclor (Ceclor); second-generation cephalosporins have more activity against gram-negative bacteria.