The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug was previously available in the US only from the manufacturer through an FDA Investigational New Drug (IND) application.Meningoencephalitis caused by the free-living amebae Naegleria fowleri, Acanthamoeba spp., or Balamuthia mandrillaris, usually acquired through the nose while swimming in warm fresh water, has a mortality rate of >90% despite treatment with multiple antimicrobial drugs.2 Miltefosine is...

The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.

The FDA has required a new warning in the label for the scopolamine transdermal patch (Transderm-Scōp, and generics) about a risk of serious or fatal hyperthermia. Scopolamine, an anticholinergic drug, is FDA-approved for prevention of nausea and vomiting associated with motion sickness or recovery after surgery in adults; it is often used off-label to reduce drooling in children and adolescents with neurologic disorders.

The US Food and Drug Administration recently approved ''Treatment IND';'; (investigational new drug) protocols for Exosurf (Burroughs Wellcome) and Survanta (Ross), two preparations of surfactant used for prevention and treatment of the respiratory distress syndrome (RDS) in premature newborn infants. Consequently, these drugs will be available to virtually every level-ΙΙΙ neonatal intensive-care unit in the USA.

Isradipine (DynaCirc - Sandoz), a dihydropyridine calcium-channel blocker chemically related to nicardipine (Cardene) and nifedipine (Procardia, and others), was recently approved by the US Food and Drug Administration for oral treatment of hypertension.

Cysteamine bitartrate (Cystagon - Mylan), an orphan drug, has been approved by the US Food and Drug Administration for oral treatment of nephropathic cystinosis, an autosomal recessive metabolic disorder that affects only a few hundred people in the USA (WA Gahl et al, in The Metabolic Basis of Inherited Disease, 7th ed., CR Scriver et al, eds, New York:McGraw-Hill, 1995, p 3763).

Irinotecan hydrochloride (Camptosar - Pharmacia & Upjohn; formerly CPT-11) has been approved by the US Food and Drug Administration for treatment of metastatic colorectal cancer refractory to other drugs including fluorouracil (5-FU; Adrucil and others).

Now that US Secretary of Defense has decided to vaccinate more than 2 million memebers of the US armed forces against anthrax, US physicians may be asked to answer some questions about the vaccine and the disease.

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

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...