The FDA has approved a sublingual film formulation of the alpha-2 adrenergic receptor agonist dexmedetomidine (Igalmi — BioXcel Therapeutics) for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first alpha-2 agonist and the only sublingual film to be approved for this indication. Dexmedetomidine has been available for many years in an injectable formulation (Precedex) for sedation in the intensive care unit and to facilitate procedures such as mechanical ventilation.

Anticoagulants are the drugs of choice for treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE). US guidelines for treatment of VTE were updated in 2020 and 2021.

Human alpha1-proteinase inhibitor (Prolastin Cutter), possibly better known as alpha1-antitypsin (ATT), is now available in the USA for replacement therapy in patients with emphysema who have a congential deficiency of the protein.

(Ceredase - Genzyme) a modified form of the glycoprotein enzyme glucocerebrosidase prepared from human placenta, was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of patients with the non-neurologic form of Gaucher's disease (Type 1).

Recent studies have caused concern about cardiomyopathy associated with doxorubicin (Adriamycin, and others), daunorubicin (Cerubidine, and others), idarubicin (Idamycin), mitoxantrone (Novantrone), and related anthracycline or anthraquinone anticancer drugs. Dexrazoxane (ADR-529, ICRF-187 - Adria), a piperazine derivative of ethylenediaminetetraacetic acid (EDTA), is now under investigation for prevention of this drug-induced cardiomyopathy.

The prostaglandin alprostadil injected into the corpus cavernosum (Caverject - Upjohn) can produce an erection in some men with erectile dysfunction (Medical Letter, 37:83, 1995). Now a pellet (microsuppository) formulation has become available for intraurethral administration of alprostadil (MUSE [Medicated Urethral System for Erection] - Vivus). It is marketed in a sterile foil pouch containing a pellet 1.4 mm in diameter and 3 or 6 mm long within the stem of a hollow applicator, which is inserted 3 cm deep into the urethra. Pressing a button pushes the pellet into the urethra.

In 2011, the FDA asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) citalopram (Celexa, and generics) to lower the maximum daily dosage of the drug because of a dose-related increase in the QT interval. Since then, some of our readers have asked whether escitalopram (Lexapro, and generics), the active enantiomer of citalopram, could have the same effect.

The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1HCV genotype 4 is uncommon in the US and Canada. It...

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

A reader expressed concern that a statement in our article Naloxone (Narcan) Nasal Spray for Opioid Overdose (Med Lett Drugs Ther 2016; 58:1) might be misleading. We stated that heroin has a half-life of 2-6 minutes, which is correct, but heroin is a prodrug that is rapidly metabolized to 6-acetylmorphine and morphine. The risk of respiratory depression is related to those active metabolites, and it may persist well beyond the clearance of heroin from the blood.