The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18, which have been associated with cervical cancer. A recombinant quadrivalent HPV vaccine (Gardasil – Merck) already on the market in the US prevents infection with HPV types 6, 11, 16 and 18.

The FDA has approved trifarotene 0.005% cream (Aklief – Galderma) for topical treatment of acne vulgaris in patients ≥9 years old. Trifarotene is the fourth topical retinoid to be approved in the US for treatment of acne; tretinoin (Retin-A, and others), adapalene (Differin, and generics), and tazarotene (Tazorac, and others) have been available by prescription for decades. Adapalene 0.1% gel has been available over the counter since 2016 for treatment of acne in patients ≥12 years old.

Omega-3 (n-3) polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential human nutrients. The main dietary source of PUFAs is fatty fish such as salmon, but small amounts may be converted from α-linolenic acid in nuts, seeds, and plant oils such as canola or flaxseed oil. An increased intake of these fatty acids has been shown to modify membrane function, inhibit thrombus formation, decrease inflammation, lower plasma triglycerides, and alter the electrical activity of the myocardium.

The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

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.

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies of up to 10 weeks' gestation. A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of the prostaglandin analog misoprostol terminates early intrauterine pregnancies in about 95% of women.

The US Food and Drug Administration recently approved the marketing of goserelin acetate (Zoladex - ICI Pharma), an implant for palliative treatment of advanced prostate cancer. Goserelin acetate is a synthetic decapeptide luteinizing hormone-releasing hormone (LH-RH) analog similar to leuprolide (Lupron; Lupron Depot) (Medical Letter, 27:71, 1985).

Doxacurium (Nuromax - Burroughs Wellcome), a new, long-acting, nondepolarizing neuromuscular blocking agent, is now available in the USA for use as a skeletal muscle relaxant during general anesthesia and for endotracheal intubation. Although small decreases in heart rate and mean arterial pressure occur in some patients who receive doxacurium, clinical studies have found no adverse cardiovascular effects in patients with heart disease receiving up to three times the usual effective dose (CM Stoops et al, Anesthesiology, 69:365, 1988; DJ Murray et al, Anesthesiology, 69:472, 1988; RS...