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.

The CDC has reported that many states are experiencing a higher-than-usual incidence of pertussis this year. The highest incidence has been in infants, but the disease has also occurred in older children, adolescents, and adults. Thirteen pertussis-related deaths were reported through August 24; the majority of these were in infants <3 months old.

The FDA has approved the over-the-counter (OTC) sale of Nasacort Allergy 24HR (Sanofi), a triamcinolone acetonide nasal spray previously available only by prescription as Nasacort AQ. The OTC product, which is scheduled to be marketed in the spring of 2014, will be the first corticosteroid nasal spray that can be purchased without a prescription in the US. Nasacort Allergy 24HR is approved for use in patients ≥2 years old with nasal allergy symptoms.

The FDA has approved the combined use of the programmed death receptor-1 (PD-1) blocking antibody nivolumab (Opdivo) and the anti-CLA-4 antibody ipilimumab (Yervoy) for treatment of BRAF V600 wild-type unresectable or metastatic melanoma. This is the first immunotherapy combination to be approved for treatment of any type of cancer.

The FDA has approved asfotase alfa (Strensiq – Alexion), a recombinant form of tissue-nonspecific alkaline phosphatase, for subcutaneous treatment of perinatal-, infantile-, and juvenile-onset hypophosphatasia. Asfotase alfa is the first treatment to be approved in the US for this rare genetic metabolic disorder.

A reader asked whether healthcare providers should avoid prescribing the angiotensin receptor blocker (ARB) olmesartan medoxomil (Benicar, and others) because it can cause severe GI adverse effects.In 2013, the FDA warned that olmesartan can cause sprue-like enteropathy, a condition characterized by intestinal villous atrophy, severe chronic diarrhea, and significant unintended weight loss. The warning was based on 23 cases of serious sprue-like enteropathy associated with use of olmesartan, some occurring years after starting the drug. All patients improved after stopping olmesartan; 10 had a...

The FDA has approved the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.

The US Food and Drug Administration recently approved the marketing of a cervical cap (Prentif Cavity-Rim Cervical Cap - Lamberts Ltd, England), a contraceptive device that has been used in one form or another for many years (JP Koch, Contraception, 25:161, 1982). The cap is being distributed in the USA and Canada by Cervical Cap (CxC), Ltd, PO Box 38003-292, Los Gatos, CA 95031, telephone 408-358-6264; the distributor will make the caps available only to practitioners who have attended training seminars.

Liquid diets for weight reduction, once discredited because of their adverse effects, are becoming popular again. Now, formula diets are available through physicians or hospitals as part of a packaged weight-reduction program that includes nutrition education and modification of eating and exercise habits. Three widely used programs are Optifast (Sandoz), Medifast (Nutrition Institute of Maryland, 1840 York Road, Timonium, MD 21093) and HMR (Health Management Resources, 59 Temple Place, Boston, MA 02111).

Moexipril hydrochloride (Univasc - Schwarz Pharma), an angiotensin-converting enzyme (ACE) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for treatment of. It is the eighth ACE inhibitor to be marketed in the USA.