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.

Butenafine hydrochloride 1% cream (Mentax - Penederm), a benzylamine antifungal drug similar to the allylamines terbinafine (Lamisil) and naftifine (Naftin), is now available in the USA for topical treatment of tinea pedis, tinea corporis and tinea cruris.

Tiludronate (Skelid - Sanofi), a chloro-4-phenylthiomethylene bisphosphonate, has been approved by the US Food and Drug Administration (FDA) for treatment of Paget's disease of bone. Characterized by excessive bone resorption and disorganized bone remodeling, Paget's disease occurs in up to 3% of people more than 55 years old in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, Feb 20, 1997).

The US Food and Drug Administration (FDA) has approved use of recombinant human interleukin 11 (rhIL-11; oprelvekin; Neumega - Genetics Institute) to increase platelet counts and decrease the need for platelet transfusions in patients with severe thrombocytopenia caused by chemotherapy for nonmyeloid malignancies.

An intranasal spray formulation of the topical corticosteroid mometasone furoate, marketed for treatment of seasonal and perennial allergic rhinitis, has been advertised on television directly to the public.