A device that stimulates the vagus nerve was approved by the FDA in July 1997 for treatment of refractory epilepsy and is now considered "approvable" for treatment-resistant depression.

Aripiprazole (Abilify - Bristol-Myers Squibb/Otsuka), a second-generation (atypical) antipsychotic drug, was approved by the FDA in 2002 for treatment of schizophrenia and more recently for bipolar disorder as well. It has been promoted as causing fewer adverse effects than other antipsychotics, without sacrificing efficacy.

Chromium is marketed as a dietary supplement, usually containing 20-500 mcg of a chromium salt. It has been promoted for weight loss, muscle building, and for prevention and treatment of diabetes, among other claims. As a dietary supplement, chromium can be sold without proof of efficacy or safety.

Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients >2 years old. Deferasirox is a tridentate (2 molecules of deferasirox bind to one atom of iron) chelating agent with high affinity for iron. It has much lower affinity for zinc and copper.

Diclofenac epolamine patch 1.3% (Flector Patch - Alpharma), a topical formulation of the nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA for topical treatment of acute pain due to minor strains, sprains and contusions. It is the first topical NSAID patch approved in the US. A diclofenac patch has been used in Europe since 1993. Diclofenac sodium (Voltaren, and others) is available in the US as an oral tablet, in a 1% gel for treatment of osteoarthritis (to be reviewed in a future issue), in a 3% gel (Solaraze) for treatment of actinic keratoses, and in an...

The FDA has approved azithromycin 1% ophthalmic solution (AzaSite - Inspire) for treatment of bacterial conjunctivitis in patients > 1 year old. It is formulated, according to the manufacturer, in a controlled-release delivery system that keeps the drug in the eye for several hours.

Spinal decompression machines offer a motorized form of mechanical traction. These devices, which are widely advertised to the public as a noninvasive alternative to surgery, are claimed to relieve low back pain by decompressing discs, improving the flow of nutrients into the disc and rehydrating dried-out discs. Devices cleared by the FDA based on substantial similarity to previously approved power traction devices include the Accu- Spina System, DRS System, DRX9000, Lordex Traction Unit, Spinal Health Elite, SpineMED Decompression Table, SpineRx-LDM and VAX-D Therapeutic Table.

Etravirine (Intelence - Tibotec), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), has received fast-track FDA approval for use in combination therapy in treatment-experienced adults who have HIV-1 infection resistant to an NNRTI and other antiretroviral agents.

Olopatadine 0.6% nasal spray (Patanase - Alcon) has been approved by the FDA for treatment of seasonal allergic rhinitis in patients ≥ 12 years old. An H1-antihistamine with mast-cell stabilizing activity, olopatadine is already marketed for treatment of allergic conjunctivitis in a 0.1% solution as Patanol and in a 0.2% solution as Pataday. Azelastine (Astelin), another H1-antihistamine with mast-cell stabilizing activity, has been available for intranasal treatment of allergic rhinitis since 1997.

The cardiovascular safety of the thiazolidinedione rosiglitazone (Avandia – GlaxoSmithKline) is in the news again, with some authorities calling for its removal from the market (New York Times, February 19, 2010).