Patients may be asking about reports in the lay press that exenatide (Byetta - Med Lett Drugs Ther 2005; 47:45), a synthetic peptide that stimulates release of insulin from pancreatic beta cells, has been used by diabetics and non-diabetics to lose weight. Approved by the FDA to improve glycemic control in patients with type 2 diabetes not controlled by metformin, a sulfonylurea or both, it is given by subcutaneous injection before the morning and evening meals. In clinical trials, some diabetic patients treated with the drug lost weight. No data are available on use in non-diabetics....

The FDA has approved tesamorelin (Egrifta – EMD Serono), an injectable synthetic analog of growth-hormone- releasing factor (GRF), for reduction of excess abdominal fat in patients with lipodystrophy associated with HIV infection. Growth hormone (somatropin – Serostim; EMD Serono) has been available for years for treatment of HIV wasting.

A new once-daily formulation of gabapentin (Gralise – Depomed) has been approved by the FDA for treatment of postherpetic neuralgia (PHN). Immediate-release (IR) gabapentin (Neurontin, and others), which has been available in the US since 1994, is also approved for this indication, but is taken three times a day. Extended-release gabapentin enacarbil (Horizant) was recently approved by the FDA for treatment of restless legs syndrome.

The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Glucarpidase has been available in the US since 2007 under a compassionate use open-label treatment protocol (Clinical Trials and Consulting Services, 1-877-398-9829), which will remain in effect until the drug becomes commercially available later this year. There is currently a shortage of IV methotrexate in the US.

The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis. Peginesatide is the third ESA to become available in the US.Overuse of the other two, which have broader indications, has been a concern.

Most experts agree that lifestyle modifications and metformin (Glucophage, and others) should be used first to treat patients with type 2 diabetes. If metformin alone fails to control hyperglycemia, there is no general agreement on which drug should be added next. A recent article in The Medical Letter offered some support for a sulfonylurea. Three recent trials published in The Lancet favored the long-acting basal insulin glargine, the glucagon-like peptide (GLP-1) analog exenatide, and the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, respectively. Some of the advantages...

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.

The FDA has approved use of Kcentra (CSL Behring), a human-derived 4-factor prothrombin complex concentrate (PCC), for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. It is the only 4-factor PCC available in the US.

The FDA has approved ibrutinib (eye broo' ti nib; Imbruvica – Janssen/Pharmacyclics), an oral kinase inhibitor, for second-line treatment of chronic lymphocytic leukemia (CLL). It is the first kinase inhibitor to be approved for CLL. Ibrutinib was approved earlier for second-line treatment of mantle cell lymphoma, a rare form of B-cell non-Hodgkins lymphoma.

The FDA has approved the interleukin-6 (IL-6) antagonist siltuximab (Sylvant – Janssen), a recombinant chimeric (human-mouse) monoclonal antibody, for treatment of multicentric Castleman's disease (MCD) in patients who are HIV negative and human herpesvirus-8 (HHV-8) negative. It is the first drug to be approved for this indication.