The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All...

The recent attack in the Tokyo subway has led to many questions about the clinical effects, treatment and prevention of nerve gas poisoning.

The FDA has approved a new low-dose estrogen patch (Menostar - Berlex) for prevention of osteoporosis in postmenopausal women. Unlike other estrogen patches, it is not approved for treatment of hot flashes or other menopausal symptoms. Promotional material from the manufacturer suggests that this low dose of estrogen could prevent osteoporosis without some of the adverse effects of higher doses.

A device that stimulates the vagus nerve was approved by the FDA in July 1997 for treatment of refractory epilepsy and is now considered "approvable" for treatment-resistant depression.

Spinal decompression machines offer a motorized form of mechanical traction. These devices, which are widely advertised to the public as a noninvasive alternative to surgery, are claimed to relieve low back pain by decompressing discs, improving the flow of nutrients into the disc and rehydrating dried-out discs. Devices cleared by the FDA based on substantial similarity to previously approved power traction devices include the Accu- Spina System, DRS System, DRX9000, Lordex Traction Unit, Spinal Health Elite, SpineMED Decompression Table, SpineRx-LDM and VAX-D Therapeutic Table.

The FDA has approved Kyleena (Bayer), an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy. It is the fourth levonorgestrel-releasing IUD to be approved in the US. Like Mirena, which has been available since 2000, Kyleena is approved for up to 5 years of use.

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.

Two cell-based gene therapies – exagamglogene autotemcel (Casgevy – Vertex) and lovotibeglogene autotemcel (Lyfgenia – Bluebird Bio) – have been approved by the FDA for treatment of sickle cell disease in patients ≥12 years old with recurrent vaso-occlusive crises. They are the first gene therapies to be approved in the US for use in sickle cell disease; Casgevy is the first treatment to be approved in the US that uses CRISPR/Cas9 gene-editing technology.

Myocardial images produced by injections of radioactive thallium chloride (201Tl), usually during exercise, have been used for many years for diagnosis of coronary artery disease (Medical Letter, 21:49, 1979). Recently, some new techniques and radiopharmaceuticals have become available for myocardial imaging.

Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA for this indication. This review describes the pharmacokinetics, adverse effects, drug interactions and recommended dosage of eletriptan. Clinical trials comparing the new drug to placebo and to sumatriptan are presented. A dosage and cost table for all the triptans available in the US is also included. The review concludes with an overall assessment of eletriptan's efficacy and...