Chromium is marketed as a dietary supplement, usually containing 20-500 mcg of a chromium salt. It has been promoted for weight loss, muscle building, and for prevention and treatment of diabetes, among other claims. As a dietary supplement, chromium can be sold without proof of efficacy or safety.

The FDA has approved the immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) that highly expresses programmed death-ligand 1 (PD-L1) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations. About 25% of patients with advanced NSCLC have tumors with high levels of PD-L1 expression (PD-L1 expressed on ≥50% of tumor cells). Pembrolizumab was approved earlier for treatment...

Now that glucosamine and chondroitin, 2 favorite over-the-counter remedies for painful osteoarthritis (OA) of the knee, have been at least somewhat discredited, some patients will be asking about alternatives. One of these is periodic intra-articular injection of a corticosteroid or hyaluronic acid preparation.

The FDA has approved a new Japanese encephalitis vaccine (Ixiaro - Intercell/Novartis). It will replace JEVax (Sanofi Pasteur), which has had tolerability and safety problems and is no longer being manufactured.

At the beginning of this year, The Medical Letter reviewed Monoclate (Armour), a new, highly purified antihemophilic factor (AHF) prepared by immunoaffinity chromatography (Medical Letter, 30:1, 1988). Monoclate is more highly purified than older Factor VIII concentrates, but whether the combination of monoclonal antibody purification and dry heat used in preparing Monoclate will be adequate to prevent transmission of hepatitis and HIV infection remains to be established. Twenty-eight patients previously untreated with Factor VIII concentrate who have received Monoclate for periods...

Use of a proton pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding in patients taking the antiplatelet agent clopidogrel (Plavix) may interfere with the activation of clopidogrel and diminish its antiplatelet effect, increasing the risk of cardiovascular events.1 A randomized, placebo-controlled trial (COGENT) has found that use of the PPI omeprazole in patients taking clopidogrel in addition to aspirin decreased the incidence of GI bleeding without increasing the risk of a cardiovascular event, but the number of cardiovascular events was small and the formulation of...

An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.The manufacturer’s application for this new indication was based on a double-blind, randomized trial (SHARP) that compared the combination of ezetimibe 10 mg and simvastatin 20 mg with placebo in 9270 patients with chronic kidney disease who did not have a history of myocardial...

The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg tablet taken once (Plan B One-Step, and generics). A third emergency contraceptive, ulipristal (Ella – Watson), is available with a prescription.1 It appears that, pursuant to a court order, Plan B One-Step (but not the generic products), which was previously available over the counter from a pharmacist only for women 17 years and older, will now be available directly from pharmacy shelves with no age...

The FDA has approved the pyrimidine analog uridine triacetate (Xuriden [zur' uh den] – Wellstat Therapeutics) for treatment of hereditary orotic aciduria, a rare autosomal recessive disorder (estimated birth prevalence: <1:1,000,000) in infants and children caused by a deficiency in uridine 5'-monophosphate (UMP) synthase. This deficiency prevents synthesis of uridine nucleotides and causes developmental delays, failure to gain weight, hematologic abnormalities, and excessive urinary excretion of orotic acid, which can lead to urinary obstruction.1 Xuriden is the first drug to be approved...

The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.