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In response to several high-profile drug misadventures including the rofecoxib (Vioxx®) withdrawal from the market, the FDA's Center for Drug Evaluation and Research (CDER) asked the Institute of Medicine (IOM) to assess the drug safety system in the United States.
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Patients with coronary artery disease who have received intra-coronary, drug-eluding stents (DES) may benefit from longer courses of clopidogrel than is currently standard.
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Although it is known that cigarette smoking is the most prevalent risk factor for lung cancer, other risk factors are important. It is notable that 10% of men and 20% of women with lung cancer never smoked, and that nearly half of patients are former smokers.
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Drug Labels A Prescription for Misunderstanding?; Beta-Blockers and Depression Unlinked?; FDA Actions
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The Non-nucleoside Reverse Transcriptase inhibitors (nnRTI's) including both efavirenz and nevirapine have intrinsic in vitro activity superior to all the other classes of antiretroviral agents. Clinical trials including patients who have been followed now for many years on efavirenz have demonstrated the durability, as well as potency, of these agents.
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Community-Associated MRSA (CA-MRSA) has emerged as an important cause of skin and soft-tissue infection. Most isolates of CA-MRSA are positive for the Panton-Valentine leukocidin (PVL), an exotoxin that is generally absent from "classic" hospital-associated MRSA strains. This suggests that PVL may be an important virulence determinant in CA-MRSA.
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The new quadrivalent Human Papillomavirus (HPV) L1 virus-like particle vaccine (types 6, 11, 16, 18) was studied for immunogenicity and reactogenicity in 506 girls and 510 boys (10-15 years of age) and 513 young women (16-23 years of age). Vaccine was administered in the standard schedule of 0, 2, and 6 months. Type-specific serologies were performed in a blinded fashion using a competitive Luminex xMAP-based immunoassay (cLIA) on serum samples obtained at 0, 3, and 7 months.