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.

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.

FK 506 (Fujisawa), an immunosuppressant similar in activity to cyclosporine (Sandimmune - Medical Letter 25:77, 1983), is currently under investigation in the USA, Europe, and Japan for prevention of organ transplant rejection.

Pegaspargase (peg as par jase; PEG-L-asparaginase; Oncaspar - Rh ne-Poulenc Rorer), a polyethylene glycol (PEG) conjugate of L-asparaginase, has been approved by the US Food and Drug Administration for treatment of acute lymphoblastic leukemia (ALL), the most common malignancy of childhood. The new drug is recommended only for patients who have had allergic reactions to asparaginase. Asparaginase is available commercially as Elspar, which is derived from Escherichia coli. A formulation derived from Erwinia chrysanthemi is available on an investigational basis (Ogden Bioservices,...

Temozolomide has received accelerated approval from the FDA for oral treatment of adults with anaplastic astrocytoma that has relapsed after treatment with a nitrosourea (lomustine or carmustine) and procarbazine.

Flosequinan (Manoplax - Boots), a fluoroquinolone derivative, is now available in the USA for treatment of congestive heart failure. Labeling approved by the US Food and Drug Administration recommends the drug only for patients who cannot tolerate or have not responded adequately to an angiotensin-converting enzyme (ACE) inhibitor.

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

Spironolactone, an aldosterone receptor antagonist, has been FDA-approved for many years for treatment of edema, hypertension and primary hyperaldosteronism. Recently, it was reported to improve morbidity and mortality in patients with severe heart failure.

The FDA has approved aflibercept (a flib’ er sept; Eylea – Regeneron) for treatment of neovascular (wet) age-related macular degeneration (AMD).