Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung cancer (NSCLC). Various combinations of cisplatin (Platinol), vinblastine (Velban, and others), mitomycin (Mutamycin), ifosfamide (Ifex), etoposide (VePesid) and paclitaxel (Taxol) have been used previously for this indication.

The US Food and Drug Administration (FDA) has approved 'early access' use of riluzole (Rilutek - Rh ne-Poulenc Rorer) for treatment of amyotrophic lateral sclerosis (ALS). is the first drug to become available for treatment of this condition. The premarketing supply is limited; the manufacturer (1-800-798-7425) has enough on hand to treat 3,000 of the 25,000 patients with the disease in the USA, and those 3,000 have already been selected through a lottery. Similar arrangements have been made in several European countries. Riluzole is not available commercially in any country.

Topotecan hydrochloride (Hycamtin - SmithKline Beecham) was recently approved by the U.S. Food and Drug Administration for parenteral use as a single agent in patients with metastatic ovarian cancer refractory to other drugs. Initial treatment for metastatic ovarian cancer usually consists of cisplatin (Platinol) or carboplatin (Paraplatin) plus paclitaxel (Taxol) or cyclophosphamide (Cytoxan, and others).

Betaine (Cystadane - Orphan Medical), an orphan drug, has recently been marketed for treatment of homocystinuria, a genetic disorder. Patients with homocystinuria frequently have premature atherosclerosis and thromboembolism, and may also have lens dislocations, skeletal abnormalities and mental retardation (SH Mudd et al in CR Scriver et al, eds, The Metabolic and Molecular Bases of Inherited Disease, 7th ed, New York:McGraw Hill, 1995, page 1279).

Many readers have asked the Medical Letter to evaluate St. John's wort, an herbal extract now widely sold in health food stores and pharmacies, for its effectiveness and safety in the treatment of depression. St. John's wort is licensed in Germany for treatment of anxiety, depression and insomnia. In the USA, it is considered a dietary supplement and has not been evaluated by the FDA.

Anagrelide (an ag' gre lide) hydrochloride (Agrylin - Roberts), a quinazolin derivative, has been approved by the FDA for oral treatment of essential thrombocythemia. Patients with this uncommon myeloproliferative disorder have an increased number of circulating platelets and are at risk for both thrombosis and hemorrhage.

Full-page advertisements in The New York Times and other newspapers have promoted use of the Crystal Ear hearing aid as an inexpensive rememdy for people with impaired hearing. Some patients may be asking their physicians about these devices.

A biodegradable polymer 'wafer' (Gliadel - Rh ne-Poulenc Rorer) impregnated with the alkylating agent carmustine (BCNU; Bicnu) has been marketed in the USA for local treatment of recurrent glioblastoma multiforme that requires re-operation. The dime-sized polyanhydride wafers are implanted into the surgical cavity left behind after resection. Release of the alkylating agent directly into the area of the tumor bypasses the blood-brain barrier (H Brem and R Langer, Sci Med, 3:1, 1996).

Lepirudin (Refludan - Hoechst Marion Roussel), a direct inhibitor of thrombin, has been approved by the FDA for use as an anticoagulant in patients with heparin-induced thrombocytopenia and thromboembolic complications.

Brinzolamide (Azopt - Alcon), a thieno-thiazine-6-sulfonamide carbonic anhydrase inhibitor, has been approved by the FDA in a 1% ophthalmic suspension for treatment of elevated intraocular pressure due to ocular hypertension or open-angle glaucoma. Brinzolamide is the second FDA-approved topical carbonic anhydrase inhibitor. Dorzolamide (Trusopt) was approved earlier (Medical Letter, 37:76, 1995).