HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.

hydrochloride (Ticlid - Syntex), a platelet aggregation inhibitor that has been available in Europe for more than a decade, was recently approved by the U.S. Food and Drug Administration to decrease the risk of thrombotic stroke in men and women who have had premonitory signs of stroke or have had a completed thrombotic stroke. The manufacturer is promoting the drug for patients intolerant to aspirin or with conditions for which aspirin has not been approved (previous thrombotic stroke; transient ischemic attacks in women). The drug has also been used for prevention of myocardial ...

Tramadol hydrochloride (Ultram - Ortho-McNeil), a centrally-acting analgesic marketed in Germany since 1977, was recently approved by the US Food and Drug Administration for oral treatment of moderate to moderately severe pain. Despite some opioid activity, tramadol has not been scheduled as a controlled substance.

Topical tretinoin (all-trans-retinoic acid) has been used for years to treat skin damaged by chronic exposure to the sun (Medical Letter, 34:28, 1992). First approved by the FDA only for treatment of acne in concentrations ranging from 0.025% to 0.1% (Retin-A, and others), it has now been approved as an 0.05% formulation in an emollient cream base (Renova) for topical treatment of photodamaged skin. In recent years, alpha-hydroxy acids incorporated in some cosmetics have also been promoted as effective in improving the appearance of aging skin.

Creatine, a natural amino acid derivative, and androstenedione, a testosterone precursor, are marketed as 'dietary supplements' in health food stores and are widely believed to enhance athletic performance. Both have been in the news recently because Mark McGwire, the baseball home-run record-setter, reportedly has said he takes both. Neither has been approved for any indication by the US Food and Drug Administration (FDA).

Entacapone (Comtan), a catechol-O-methyltransferase (COMT) inhibitor, has been approved by the FDA for adjunctive use with levodopa/carbidopa in patients with Parkinson's disease who have end-of-dose "wearing off"symptoms.

Phytoestrogens, plant compounds that are converted to estrogens in the gut, are widely promoted as "natural"substitutes for estrogen in hormone replacement therapy.

The FDA has approved exemestane, an aromatase inhibitor, for the treatment of postmenopausal women with advanced breast cancer that has progressed during treatment with tamoxifen.

Ciclopirox nail lacquer (Penlac - Dermik) has been approved by the FDA for treatment of mild-to-moderate onychomycosis due to Trichophyton rubrum, without involvement of the lunula. The drug has been available for many years as a lotion and cream (Loprox) for treatment of cutaneous fungal infection

Photodynamic therapy with verteporfin (Visudyne--CIVA Vision), an injectable drug, is now being used for treatment of age-related macular degeneration. The drug is a benzoporphyrin derivative that, when activated by light in the presence of oxygen, generates highly reactive radicals that damage neovascular endorthelium and occlude the vessels.