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 CDC has issued a recommendation for use of a single dose of doxycycline for post-exposure prophylaxis (PEP) of bacterial sexually transmitted infections (STIs), specifically syphilis, chlamydia, and gonorrhea, in men who have sex with men (MSM) and transgender women (TGW) who had a bacterial STI within the previous 12 months.

Diclofenac sodium (Voltaren - Geigy), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1974, was recently introduced in the USA for treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It is being promoted as 'The number one prescribed antiarthritic in the world.'

Moricizine (mor i'; siz een) hydrochloride (Ethmozine - Du Pont), a class I antiarrhythmic drug developed in the USSR, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of life-threatening ventricular arrhythmias.

The FDA has approved an auto-injector formulation of testosterone enanthate (Xyosted – Antares Pharma) for once-weekly subcutaneous self-administration in adult males with conditions associated with a deficiency or absence of endogenous testosterone. It is the first subcutaneous formulation of testosterone to be approved by the FDA. Xyosted is contraindicated for treatment of low testosterone levels associated with aging.

Posaconazole (Noxafil - Schering-Plough), an oral azole antifungal with a chemical structure similar to that of itraconazole (Sporanox), has been approved by the FDA to prevent Candida and Aspergillus infections in severely immunocompromised patients and for treatment of oropharyngeal candidiasis. It is likely also to be used off-label for treatment of other fungal infections, including those caused by Mucor and other Zygomycetes.

Fibrates, niacin and fish oil are promoted for treatment of hypertriglyceridemia. HMG-CoA reductase inhibitors (statins) can lower elevated serum concentrations of triglycerides, but less so than fibrates, niacins or fish oil. Lifestyle changes such as weight reduction, exercise and decreasing alcohol intake can also lower serum triglyceride levels and should be tried first.

Two new drugs alendronate (Fosamax - Merck) and salmon calcitonin nasalspray (Miacalcin - Sandoz) are now available in the USA for treatment of postmenopausalosteoporosis. A third drug for treatment of osteoporosis, a slow-release fluoridepreparation (Slow Fluoride -Mission Pharmacal), has been recommended for approvalby an advisory committee of the US Food and Drug Administration (FDA). Various formulationsof fluoride have been available in Europe for this indication for many years.

An extended-release formulation of carbamazepine, available since 1997 for treatment of epilepsy, has now been approved under a new name, Equetro, for acute mania and mixed episodes of bipolar disorder. Although the drug was effective in some patients for up to 6 months, it has not been approved for maintenance treatment. Carbamazepine has not been shown to be more effective than lithium or valproate, and it can cause serious adverse effects.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter