Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

A cyclosporine 0.05% ophthalmic emulsion (Restasis - Allergan) has been approved by the FDA for use in patients with dry eye disease (keratoconjunctivitis sicca). This review begins with a discussion of the causes of dry eye disease and includes sections on the pharmacology, adverse effects and clinical trial results for ophthalmic cyclosporine. Cost information and recommendations for administering the drug are also presented. The review concludes with an overall assessment of the drug's efficacy, safety and cost.

Azelaic acid 15% gel (Finacea Berlex) is now available in the US for treatment of mild to moderate rosacea. A 20% cream formulation of the drug (Azelex Allergan; Medical Letter 1996; 38:52) has been marketed here since 1996 for treatment of acne. The effectiveness of Finacea compared to its own vehicle and to metronidazole gel is discussed. Information on the drug's mechanism of action, adverse effects, dosage and cost are also included.

The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

Even though it is unlikely that people living in the US will be at risk of significant radiation exposure from the nuclear accident in Japan, some readers have suggested a review of the use of potassium iodide (KI) in such circumstances. Potassium iodide taken orally before or at the time of exposure can limit or prevent uptake of radioactive iodine by the thyroid gland.

The FDA has approved vemurafenib (Zelboraf – Genentech), a kinase inhibitor, for treatment of unresectable or metastatic melanoma with the BRAF V600E mutation, which is found in 30-60% of melanomas. An FDA-approved test can detect the mutation in DNA from melanoma tissue.

The FDA has approved the use of the phosphodiesterase-5 (PDE-5) inhibitor tadalafil (Cialis – Lilly) for treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in men with or without erectile dysfunction. Tadalafil is approved for use under another brand name (Adcirca) for treatment of pulmonary arterial hypertension. The other PDE-5 inhibitors available in the US for treatment of erectile dysfunction (sildenafil [Viagra]; vardenafil [Levitra]) have also been reported to be effective for treatment of BPH signs and symptoms, but have not been approved for this...

The FDA has approved a nasal spray formulation of fentanyl (Lazanda – Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.

Transcatheter aortic-valve replacement (TAVR), a procedure in which a prosthetic valve is inserted into the aortic annulus by a catheter, has been approved by the FDA as an alternative to surgical aortic-valve replacement for patients with severe symptomatic aortic stenosis who are considered inoperable.

The FDA has approved the selective alpha₂-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial erythema of rosacea. Brimonidine is also available in ophthalmic formulations for treatment of glaucoma.