Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

This winter physicians in many area may see patients suffering from hypothermia. Old age, lack of adequate housing, drug overdose and alcohol ingestion are often prediposing factors, but hypothermia also occurs in healthy young people after prolonged exposure to cold due to incapacitating trauma or cold water immersion. Hypothermia associated with exhaustionduring outdoor sports activities can occur even at relatively mild temperatures.

Metformin (Glucophage - Bristol-Myers Squibb), a hypoglycemic agent, was recently marketed in the USA for oral treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not adequately controlled by diet alone. Previously marketed in more than ninety countries, including Canada, metformin (dimethylbiguanide) is chemically related to phenformin (phenylethylbiguanide), which was withdrawn from the US market in 1976 because it caused a high incidence of lactic acidosis. In approving metformin, the US Food and Drug Administration stipulated that a post-marketing controlled...

High-dose chemotherapy followed by bone marrow transplantation continues to be widely used in the treatment of malignant diseases (Medical Letter, 37:25, 1995). The source of the transplant has been autologous or allogeneic bone marrow or, more recently, stem and progenitor cells harvested from peripheral blood (Medical Letter, 37:71, 1995). Now, blood taken from the umbilical cord and placenta of a newborn infant is being tried as a source of cells to restore the bone marrow. A single collection of umbilical cord blood contains about as many progenitor cells as most autologous bone...

Rabeprazole, a benzimidazole proton pump inhibitor similar to omeprazole and lansoprazole, has been approved by the FDA for treatment of duodenal ulcers, healing and maintenance treatment of erosive or ulcerative gastroesophageal reflux disease, and for long-term treatment of chronic hypersecretory conditions, including Zollinger-Ellison syndrome

Methylphenidate is now available in a new extended-release formulation (Metadate CD - Celltech) for treatment of attention deficit/hyperactivity disorder (ADHD). The new product, which is a Schedule II controlled substance, is being advertised directly to consumers.

Palifermin (Kepivance - Amgen), a recombinant human keratinocyte growth factor (KGF), has been approved by the FDA to decrease the incidence and duration of severe oral mucositis (OM) in patients with hematologic malignancies receiving myelotoxic chemotherapy and hematopoietic stem cell (HSC) rescue.

The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.

The FDA has approved Bexsero (Novartis/GSK), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. It is the second serogroup B meningococcal vaccine to be approved in the US; Trumenba was the first. Both vaccines are approved for use in persons 10-25 years old. Bexsero is approved in Europe, Canada, and Australia for use in children as young as 2 months old.

The FDA has approved abaloparatide (Tymlos – Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo – Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption.