Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.

Fluconazole (Diflucan - Roerig), an antifungal azole, was recently approved by the US Food and Drug Administration for oral and intravenous (IV) treatment of cryptococcal meningitis and various forms of candidiasis. Both cryptococcal meningitis and candidiasis occur frequently in patients with AIDS, organ transplants, or cancer.

Clozapine (Clozaril - Sandoz), an antipsychotic drug, was first marketed in the USA three years ago (Medical Letter, 32:3, 1990). Because of its hematological toxicity, the US Food and Drug Administration approved the drug only for patients with schizophrenia who cannot tolerate or do not respond to standard antipsychotic drugs.

Carvedilol (Coreg - SmithKline Beecham and Boehringer-Mannheim), a betaadrenergic and alpha-adrenergic blocker approved by the FDA for treatment of hypertension in 1995, but not marketed at that time, has now been approved and marketed for treatment of mild or moderate (NYHA class II or III) heart failure stabilized on other drugs. It is being promoted as an add-on drug that reduces the morbidity and mortality of the disease.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.

The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002;...

The July 2003 edition of the Canadian Adverse Reaction Newsletter, published by Health Canada (the Canadian FDA), reported that the Health Canada database had received more spontaneous reports of hypoglycemia (19) and hyperglycemia (7) with gatifloxacin (Tequin) than with other quinolone antibiotics.

The first commercially available virucidal tissue, KLEENEX Anti-Viral Tissue (Kimberly-Clark), was recently introduced and is being heavily promoted to the general public. Patients may ask healthcare providers about the usefulness of these products. Theoretically, virucidal tissues could interrupt transmission of viral infections by blocking hand contamination and/or small particle aerosols from nose-blowing, sneezing and coughing.

Currently available techniques for colorectal cancer screening include fecal occult-blood testing, flexible sigmoidoscopy, double contrast barium enema (DCBE) and traditional optical colonoscopy. Optical colonoscopy requires bowel cleansing and sedation, and involves some risk, but is generally accepted as the best available method for detection of lesions and offers the advantage that polyps can be removed when they are identified. A less invasive screening tool, computed tomography (CT) colonography, also known as virtual colonoscopy (VC), offers an additional option.

The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular Assay (Third Wave Technologies) detects the UGT1A1*28 allele, a variation in the uridine diphosphate glucuronosyltranferase 1A1 (UGT1A1) gene. The FDA recently revised the safety labeling for irinotecan, recommending that the dosing of irinotecan be reduced for patients who are homozygous for the UGT1A1*28 allele.