The FDA has approved a new formulation of dexrazoxane (Totect) for treatment of extravasation from intravenous (IV) anthracyclines such as doxorubicin (Adriamycin, and others). Dexrazoxane has been available since 1995 as Zinecard for protection against the cardiac toxicity of anthracyclines (Med Lett Drugs Ther 1995; 37:110). It is also available generically. The drug’s precise mechanism of action is not known, but anthracyclines are vesicants that bind to DNA and act as oxidizing agents in the presence of iron. Dexrazoxane is a topoisomerase inhibitor, possibly interfering with...

Lubiprostone (Amitiza), which was previously approved for treatment of chronic idiopathic constipation in adults, has now also been approved in a lower dose for use in women with irritable bowel syndrome with constipation (IBS-C). Since tegaserod (Zelnorm) has been withdrawn from the market,2 lubiprostone is the only drug approved by the FDA for treatment of this common condition.

The FDA has approved subcutaneous injection of methylnaltrexone (Relistor - Wyeth/Progenics), a selective mu-opioid receptor antagonist, for treatment of opioid-induced constipation in patients with advanced illness (such as incurable cancer or end-stage chronic obstructive pulmonary disease) who are receiving palliative care.

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

Resveratrol is a phytochemical found in the skin of red grapes and in many other plants, including berries, plums and peanuts. As a constituent of red wine, it has been associated with cardioprotective effects. Dietary supplements containing resveratrol are now being widely promoted as antioxidants that can prevent agerelated diseases.

The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved pralatrexate (Folotyn – Allos), an intravenous (IV) antifolate, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the first drug approved by the FDA specifically for this indication.

Vilazodone (Viibryd – Forest), a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT_1A receptor agonist, has been approved by the FDA for treatment of depression. It has been claimed to have no sexual side effects and not to cause weight gain.

The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table summarizing contraceptive methods available in the US appears on page 22.

The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults who are dependent on parenteral support.