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.

Consensus recommendations for dosing and therapeutic monitoring of intravenous (IV) vancomycin (Vancocin, and others) were recently published. IV vancomycin has been used for decades as an alternative to penicillins for treatment of serious infections due to gram-positive cocci. In recent years, the widest use of the drug has been for treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections.

A 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23 - Merck) is the only pneumococcal vaccine approved for use in adults. It has reduced the risk of invasive pneumococcal disease (meningitis or bacteremic pneumonia), but not mortality, in immunocompetent older adults.2 PPSV23 has not been shown to reduce the risk of invasive pneumococcal disease (IPD) in immunocompromised patients.

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The FDA has approved artemether-lumefantrine (Coartem - Novartis) for oral treatment of uncomplicated Plasmodium falciparum malaria. It is not approved for prophylaxis. Artemether-lumefantrine is the first artemisinin-based drug approved for use in the US. Artemisinins are Chinese herbal products used worldwide to treat malaria. The intravenous formulation of artesunate, another artemisinin, is available in the US through the CDC.

Conflicting recommendations on when to screen for breast cancer are problematic for healthcare providers. The recent recommendation by the US Preventive Services Task Force (USPSTF) against routine screening mammography for women 40-49 years old conflicts with recommendations made by other organizations such as the American Cancer Society and earlier recommendations made by the USPSTF in 2002.

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