The recent terrorist attacks on the US have led to many questions about the clinical effects, prevention and treatment of injury caused by chemical warfare agents.

Arformoterol tartrate (Brovana - Sepracor), a singleisomer, long-acting beta₂-agonist, has been approved by the FDA as an inhalation solution for nebulization for treatment of bronchoconstriction pulmonary disease (COPD). Arformoterol is the (R,R)-enantiomer of formoterol (Foradil), which is available as a powder for inhalation and was recently also approved as a solution for nebulization (Perforomist - Dey; available fall 2007)

Microx (Pennwalt), a new low-dosage formulation of the thiazide-type diuretic metolazone (Zaroxolyn; Diulo), was recently marketed in the USA. The manufacturer claims that the low dose of controls hypertension with less potassium loss, making it safer than other diuretics and as effective as combination drugs, such as Dyazide, that include both a thiazide and a potassium-sparing diuretic. Medical Letter consultants generally do not recommend Dyazide or other fixed-dose combinations for treatment of hypertension.

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.

The FDA has approved Fortesta (Endo), a topical gel, for testosterone replacement therapy in adult males with hypogonadism. It is classified as a Schedule III controlled substance. Table 1 lists some available testosterone products, including 2 other gels.

The FDA has approved a fixed-dose combination of lumacaftor and ivacaftor (Orkambi – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who are homozygous for the F508del mutation. About 50% of patients in the US with CF are homozygous for the F508del (also called Phe508del) mutation. This is the first approved indication for lumacaftor; ivacaftor is available alone as Kalydeco for treatment of CF in patients ≥2 years old with other mutations. Orkambi is the first drug to be approved in the US for treatment of patients with the F508del...

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

Tretinoin (tret' i noyn; all-trans-retinoic acid; Retin-A), a derivative of vitamin A, has been used for years for topical treatment of acne. More recently, it has also been used to improve the appearance of skin damaged by chronic exposure to the sun, although not approved for this indication by the US Food and Drug Administration.

Paclitaxel (Taxol - Bristol-Myers Squibb) is now available in the USA for treatment of metastatic ovarian cancer refractory to other drugs. The new drug is a natural product extracted in small amounts from the inner bark of the Western yew tree found mainly in the Pacific northwest (Taxus brevifolia). Efforts to synthesize the drug have been unsuccessful to date, but a semi-synthetic product (taxotere) prepared from the needles of European yews has shown some promise (R Pazdur et al, J Natl Cancer Inst, 89:1781, 1992), and a fungus (Taxomyces andreanae) growing on the Pacific yew was...

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.