Once thought to be a beneficial response to critical illness, hyperglycemia is now recognized as independently associated with death and other adverse outcomes in various groups of critically ill patients. Whether normalization of blood glucose by insulin infusion is beneficial in such patients has been a subject of debate in the critical care community. Some new guidelines have been published.

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The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

The FDA has approved a dextroamphetamine transdermal patch (Xelstrym – Noven) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Xelstrym is the first transdermal amphetamine product to be approved in the US. A methylphenidate transdermal patch (Daytrana, and generics) has been available for years for treatment of ADHD.

The FDA has approved ensifentrine (Ohtuvayre – Verona), an inhaled phosphodiesterase (PDE) 3 and 4 inhibitor, for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It is the first dual inhibitor of PDE3 and PDE4 to be approved by the FDA, and the first inhaled drug with a new mechanism of action to be approved for treatment of COPD in more than 20 years.

Several large European observational studies published on-line this summer have raised questions about whether use of insulin glargine increases the risk of cancer.

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

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 moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

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Testosterone is now available in a 1% gel (AndroGel - Unimed) for treatment of hypogonadism in men. AndroGel, which is rubbed on the skin, is the fourth transdermal preparation of testosterone to be marketed in the USA.