The FDA recently approved the proton pump inhibitor omeprazole magnesium (Prilosec OTC) for over-the-counter use for treatment of frequent heartburn. It will be marketed in late September or early October. Five proton pump inhibitors, including omeprazole, are available by prescription in the US (Medical Letter 2001; 43:36).

A recent article in the New England Journal of Medicine confirms something that others, including The Medical Letter (Treat Guidel Med Lett 2008; 6:23), have been saying for years: no particular combination of protein, carbohydrate and fat in the diet offers any advantage in losing weight. This randomized 2-year trial followed 800 overweight and obese subjects on low fat/average protein, low fat/high protein, high fat/average protein, and high fat/high protein diets. Carbohydrate intake varied from 35% (in the high fat/high protein diet) to 65% (in the low fat/average protein diet). All...

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

The FDA has approved aflibercept (a flib’ er sept; Eylea – Regeneron) for treatment of neovascular (wet) age-related macular degeneration (AMD).

Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head comparisons of these agents are still lacking, but some differences between them and new recommendations for their dosing (see Table 2) are worth noting.

The FDA has approved deferiprone (de fer’ i prone; Ferriprox – ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload due to blood transfusions (transfusional hemosiderosis) in patients with thalassemia. Two other iron chelating agents, deferoxamine (Desferal, and others), which is usually administered subcutaneously, and oral deferasirox (Exjade), are available for use as first-line therapy in the US.

The intramedullary venous plexus of cancellous bone marrow does not collapse in patients who are dehydrated or in shock. Intraosseous (IO) infusion through an intramedullary cannula has effectively replaced central venous catheterization (CVC) as the method of choice for rapid vascular access in both adults and children when peripheral veins are inaccessible. Absorption of fluids into the central circulation with IO infusion is equivalent to absorption from IV sites, and IO access can be achieved more rapidly and with a higher success rate than CVC.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...