Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

Immune-mediated hemolysis is a rare adverse effect of second- and third-generation cephalosporins, especially cefotetan (Cefotan) (PA Arndt et al, Transfusion 1999; 39:1239). A recent report serves as a reminder that life-threatening immune-mediated hemolysis rarely can follow administration of ceftriaxone (Rocephin), one of the most commonly used parenteral antibiotics in the US (A Citak et al, J Paediatr Child Health 2002; 38:209).

Renal colic is a common problem in emergency departments. Stones <5 mm in diameter often pass spontaneously; stones >10 mm in diameter generally do not. The usual treatment for stones that do not pass is ureteroscopy with laser lithotripsy or shockwave lithotripsy. Some clinicians have suggested that off-label use of an oral alpha-adrenergic blocker such as tamsulosin (Flomax, and others) or calcium channel blocker such as nifedipine (Procardia XL, and others) could be tried first, with or without a corticosteroid. Both adrenoreceptors and calcium channels may have a role in the...

Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis. An orally inhaled dry powder formulation of the aminoglycoside antibiotic tobramycin (Tobi Podhaler – Novartis) has been approved by the FDA for management of P. aeruginosa pulmonary infection in cystic fibrosis patients ≥6 years old. The new formulation is administered via a hand-held pocket-sized inhaler. Tobramycin is also available as an...

The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

The FDA has approved fixed-dose combinations of metformin with either canagliflozin (Invokamet) or dapagliflozin (Xigduo XR) for treatment of patients with type 2 diabetes not adequately controlled with any one of these drugs, or in those already being treated with both metformin and either canagliflozin or dapagliflozin.

Golodirsen (Vyondys 53 — Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in the ~8% of patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping. It is the first drug to be approved for this indication and the third to be approved for treatment of DMD; the antisense oligonucleotide eteplirsen (Exondys 51) and the oral corticosteroid deflazacort (Emflaza) were approved earlier.

The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

Asciminib (Scemblix – Novartis), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with ≥2 tyrosine kinase inhibitors and for adults with Ph+ CML in CP with a T315I mutation.