A study now available on the web site of The New England Journal of Medicine (LY Park-Wyllie et al. Outpatient gatifloxacin therapy and dysglycemia in older adults. www.nejm.org, published online March 1, 2006) reports an increased risk of hypoglycemia (RR 4.3) and hyperglycemia (RR 16.7) with use of gatifloxacin (Tequin), a fluoroquinolone antibiotic. The Medical Letter published an article on this risk in 2003 (vol. 45, page 64); at that time the extent to which other fluoroquinolones carried the same risk was unclear. The recent report indicates that, except for a slightly increased...

The FDA has approved the use of a responsive neurostimulator device (RNS System – NeuroPace) for adjunctive treatment of adults with partial-onset seizures that are not controlled with ≥2 antiepileptic drugs and who have frequent and disabling seizures and no more than 2 epileptogenic foci.

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.

The FDA has approved vancomycin oral solution (Firvanq – Cutis Pharma) for treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (MRSA).

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

The tissue plasminogen activator (tPA) tenecteplase (TNKase – Genentech) has been approved by the FDA for treatment of acute ischemic stroke in adults. It is the second tPA to be approved in the US for this indication; alteplase (Activase) was approved in 1996. Tenecteplase was approved in 2000 to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI).

Prademagene zamikeracel (Zevaskyn – Abeona Therapeutics), an autologous cell sheet-based gene therapy, has been approved by the FDA for treatment of wounds in patients with recessive dystrophic epidermolysis bullosa. It is the first autologous cell sheet-based gene therapy to be approved in the US for this indication. Beremagene geperpavek gel (Vyjuvek), a herpes simplex virus type 1 vector-based gene therapy, is approved for once-weekly use in patients ≥6 months old with recessive dystrophic epidermolysis bullosa.

Zusduri (UroGen), a mitomycin-based solution for intravesical instillation, has been approved by the FDA for treatment of recurrent low-grade intermediate-risk nonmuscle invasive bladder cancer (NMIBC) in adults. It is the first drug to be approved in the US for this indication. Mitomycin has been available for years for treatment of various malignancies.

About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to prevent disease progression and complications such as acute urinary retention. The American Urologic Association's guidelines for treatment of BPH were recently updated.

Doconsanol 10% cream, a long-chain saturated alcohol, has been approved by the FDA for over-the-counter treatment of herpes labialis.