The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.

Tegaserod maleate (Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults <65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic cardiovascular events (including...

Opioids delay gastric emptying and the absorption of many oral drugs, including the P2Y₁₂ inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta), which are commonly used for initial treatment of acute coronary syndrome (ACS). An article in our February 25, 2019 issue reviewed studies showing that coadministration of opioids delayed and decreased absorption of oral P2Y₁₂ inhibitors and increased platelet reactivity. Recently published clinical outcomes data may add to these concerns.

Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).

Etodolac (Lodine - Wyeth-Ayerst), a nonsteroidal anti-inflammatory drug (NSAID) available in Europe for several years, was recently approved by the U.S. Food and Drug Administration for use in osteoarthritis and as a general-purpose analgesic. It has not been approved for treatment of rheumatoid arthritis.

Famciclovir (Famvir - SmithKline Beecham) is now available in the USA for oral treatment of acute uncomplicated herpes zoster (shingles). The manufacturer claims that use of the drug reduces the duration of postherpetic neuralgia. Famciclovir is similar to acyclovir (Zovirax - Burroughs Wellcome), which has been the drug of choice for treatment of varicella-zoster and herpes simplex virus infections (Medical Letter, 36:27, 1994).

Glimepiride (Amaryl - Hoechst Marion Roussel), a new sulfonylurea similar to glyburide and glipizide (Medical Letter, 26:79, 1984), was recently marketed for treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not controlled by diet and exercise. The new drug is the first sulfonylurea approved by the US Food and Drug Administration (FDA) for use concurrently with insulin.

Colesevelam hydrochloride (Welchol - Sankyo Pharma), a nonabsorbed hydrophilic polymer that binds bile acids, has been approved by the FDA for reduction of plasma LDL cholesterol in patients with primary hypercholesterolemia.