Items in AFP with MESH term: United States Food and Drug Administration

Pages: 1 2 3 Next

Prevention of Meningococcal Disease - Article

ABSTRACT: Invasive disease caused by Neisseria meningitidis has an average annual incidence of one case per 100,000 in the United States. The disease can be rapidly fatal or result in severe neurologic and vascular sequelae despite antibiotic therapy. Antibiotic chemoprophylaxis with rifampin, ciprofloxacin, or ceftriaxone is required for household and other close contacts. Although the majority of cases of meningococcal disease are sporadic, outbreaks can occur, and vaccination of the affected population often is necessary. Serogroup B accounts for the highest incidence of disease in young infants but is not contained in any vaccine licensed in the United States. Adolescents and young adults 15 to 24 years of age have a higher incidence of disease and a higher fatality rate than other populations. Because 70 to 80 percent of these infections in the United States are caused by meningococcal serogroups C, Y, and W-135, which are contained in the tetravalent meningococcal vaccines, they are potentially preventable. The U.S. Food and Drug Administration recently approved a meningococcal conjugate vaccine containing serogroups A, C, Y, and W-135. This T-cell-dependent vaccine induces bactericidal antibody production and promotes immunologic memory that should result in a longer duration of immunity. The Advisory Committee on Immunization Practices recommends that this vaccine be given to 11- and 12-year-old adolescents, to adolescents entering high school, and to college freshmen living in dormitories. The vaccine also may be given to persons 11 to 55 years of age who belong to certain high-risk groups.


Significant FDA Approvals in 2000 - FDA Perspective


Clinical Briefs - Clinical Briefs


Clinical Briefs - Clinical Briefs


Significant FDA Approvals in 2001 - Practice Guidelines


Redefining Appropriate Use of Antibiotics - Editorials


At-Home Genetic Tests - Curbside Consultation


Identifying Effective Alternative Therapies for Common Conditions - Editorials


FDA Boxed Warnings: How to Prescribe Drugs Safely - Article

ABSTRACT: Boxed warnings, commonly referred to as 'black box' warnings, are issued by the U.S. Food and Drug Administration and featured in the labeling of drugs associated with serious adverse reactions. These safety concerns are typically identified through the Adverse Event Reporting System and the Office of Surveillance and Epidemiology, which evaluates postmarket safety findings. The most common type of warning is issued when there is a potentially serious adverse effect that must be carefully weighed against the potential benefit of the drug. Warnings are also issued to draw attention to dosing, monitoring requirements, and potential drug interactions. Boxed warnings have been issued recently for oral sodium phosphate bowel preparations, fluoroquinolone antibiotics, and salmeterol. Despite these highly publicized warnings, all of these medications remain viable treatment options with appropriate patient selection. Ultimately, physicians must decide whether to prescribe drugs with boxed warnings.


Boxed Warnings and Other FDA Communication Tools - Editorials


Pages: 1 2 3 Next


Information From Industry