The US Food and Drug Administration (FDA) recently approved the marketing of clarithromycin (Biaxin - Abbott), a macrolide antibiotic, and omeprazole (Prilosec - Astra Merck), a proton pump inhibitor, for concurrent use in treatment of duodenal ulcers associated with Helicobacter pylori.

The US FDA has approved use of palivizumab for prevention of respiratory syncytial virus (RSV) infection in high-risk infants and children.

The US Food and Drug Administration has ordered removal of phenylpropanolamine from over-the-counter cold remedies and weight loss aids. The FDA based its decision on a recent study showing an increased risk of hemorrhagic stroke in young women taking the drug.

The FDA has approved a new formulation of fluoxetine for once-weekly maintenance treatment of depression in patients who have responded to daily fluoxetine (Prozac).

The media recently reported that the FDA has threatened to withdraw Synthroid from the market, alarming many physicians and patients.

Lipoprotein associated phospholipase A₂ (Lp-PLA₂), an enzyme involved in the repair of oxidative damage to lipoproteins, causes release of inflammatory mediators associated with atherosclerosis. A new assay, PLAC (diaDexus, Inc.), is now available to measure Lp-PLA₂ levels. C-reactive protein (CRP), another inflammatory mediator, appears to be a biomarker for coronary disease (MH Shishehbor et al, Cleve Clin J Med 2003; 70:634). The role of Lp-PLA₂ testing in determining cardiovascular risk is less clear.

Recombinant human α-L-iduronidase (laronidase; Aldurazyme BioMarin/Genzyme), an orphan drug, has been approved by the FDA for enzyme replacement therapy in mucopolysaccharidosis (MPS) type I, a lysosomal storage disorder caused by deficiency of the enzyme. This review describes the disease, treatment, adverse effects and cost.

Seasonale (Barr), the first "extended-cycle" oral contraceptive, is now available in the US for pregnancy prevention. Active tablets containing 30 ╡g of ethinyl estradiol and 0.15 mg of levonorgestrel are taken for 84 consecutive days, followed by 7 days of inactive tablets, allowing for withdrawal bleeding only four times a year. Other combination oral contraceptives are dispensed as 21 days of active tablets and 7 days of placebo or no tablets, resulting in 13 withdrawal bleeding episodes each year.

A nasal spray formulation of cyanocobalamin (Nascobal – Questcor) has been approved by the FDA for maintenance treatment of vitamin B12 deficiency. Nascobal is already available as an intranasal gel. Vitamin B12 deficiency, diagnosed by elevated serum concentrations of methylmalonic acid with or without elevated serum homocysteine and low serum B12 concentrations (<200 pg/mL), is common in older patients.1Since intestinal absorption of B12 may be impaired, the usual maintenance treatment of deficiency is intramuscular injection of the vitamin in doses of 1 mg every 4 weeks (after more...

The results of a randomized, placebo-controlled trial of calcium and vitamin D supplements in more than 36,000 postmenopausal women, conducted as part of the Women’s Health Initiative (RD Jackson et al. N Engl J Med 2006; 354:669), have been misinterpreted by some patients to mean that they should stop taking such supplements.At the time of recruitment, the participants in this study had an average daily calcium intake of 1100-1200 mg. They were randomized to take either 1000 mg of calcium carbonate plus 400 IU of vitamin D3 or a placebo for an average of 7 years. Both groups were permitted...