The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily treatment of cystic fibrosis (CF) in patients ≥6 years old who have at least one F508del mutation or another responsive mutation in the CFTR gene. This is the first approval for vanzacaftor and for deutivacaftor, a deuterated form of ivacaftor. Trikafta, a twice-daily oral fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor, is FDA-approved for the same indication...

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.

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 a new interferon beta-1b product (Extavia – Novartis) for treatment of relapsing forms of multiple sclerosis (MS). Extavia is identical to Betaseron (Bayer); both are produced in the same factory and packaged separately.

The FDA has approved several significant changes in the labeling of mifepristone (Mifeprex – Danco), an oral antiprogestin that has been used in the US for more than 15 years for termination of intrauterine pregnancy. It has generally been used with the prostaglandin analog misoprostol (Cytotec, and generics).

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.

Fexofenadine (Allegra, and others) is the most recent second-generation H₁-antihistamine to become available over the counter (OTC). Cetirizine (Zyrtec, and others) and loratadine (Claritin, and others) are already available OTC. Cetirizine can be sedating in usual doses. Loratadine can be sedating in higher-than-usual doses. Fexofenadine remains nonsedating even in higher doses.

The recent Medical Letter article on vitamin supplements1 included 2 sentences on vitamin E that could be misleading. "Vitamin E in food, which is mostly gamma-tocopherol, acts as an antioxidant. Vitamin E in supplements is mostly alpha-tocopherol, which may block the anti-oxidant effect of gamma-tocopherol and may have a pro-oxidant effect in vivo."Gamma-tocopherol is the most common form of vitamin E in the North American diet, and supplements are mostly alpha-tocopherol, which can, under some conditions, have a pro-oxidant effect. However, there is no evidence that taking supplements can...

Anistreplase (Eminase - SmithKline Beecham, Upjohn), a plasminogen activator also known as APSAC, was recently approved by the US Food and Drug Administration (FDA) for intravenous (IV) thrombolytic treatment of coronary thrombosis. Three other thrombolytic agents - intracoronary urokinase (Abbokinase) and intracoronary or intravenous streptokinase (Streptase; Kabikinase) and alteplase (TPA; Activase)- were previously approved for coronary thrombolysis (Medical Letter, 29:107, 1987).

Sapropterin (Kuvan - BioMarin) has been approved by the FDA to reduce phenylalanine plasma concentrations in patients with phenylketonuria (PKU). PKU is a rare genetic disorder (it occurs in 1 in 8000 Caucasian and 1 in 50,000 African-American newborns) caused by a deficiency of phenylalanine hydroxylase (PAH) the resulting high levels of the amino acid in blood and urine lead to cognitive, behavioral and other neurological complications.