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This Week in JAMA
May 1, 2002

This Week in JAMA

JAMA. 2002;287(17):2179. doi:10.1001/jama.287.17.2179
Warnings and Withdrawals for Newly Approved Drugs

Adverse drug reactions (ADRs) may be discovered only after a drug has been on the market. Lasser and colleaguesArticle analyzed the incidence of new black box warnings in the Physicians' Desk Reference for drugs approved between 1975 and 1999, as an indicator of serious ADRs, and calculated the frequency and timing of drug withdrawals. Fifty-six of 548 drugs acquired a new black box warning or were withdrawn between 1975 and 2000. Half of the drug withdrawals occurred within 2 years of drug approval, and half of the black box warnings occurred within 7 years. In an editorial, Temple and HimmelArticle consider the types of ADRs that resulted in black box warnings or withdrawals and examine how the potential for ADRs should influence prescribing of newly approved drugs.

Preoperative β-Blocker Therapy in CABG Surgery

β-Blocker therapy has been shown to improve perioperative outcomes among high-risk patients undergoing major noncardiac and vascular surgical procedures. Ferguson and colleagues analyzed data from the Society of Thoracic Surgeons National Adult Cardiac Surgery Database to assess the use of preoperative β-blocker therapy in patients undergoing isolated coronary artery bypass graft (CABG) surgery and to determine whether β-blocker therapy is associated with decreased operative mortality and morbidity. Overall use of preoperative β-blocker therapy increased from 50% to 60% from 1996 to 1999. Patients who received preoperative β-blocker therapy had slightly lower operative mortality than those who did not receive β-blocker therapy, except among patients with a left ventricular ejection fraction of less than 30%, and some reduction in procedural complications.

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Pathogenesis of High-Altitude Pulmonary Edema

Acute elevation of pulmonary vascular pressures is a primary event in the pathogenesis of high-altitude pulmonary edema (HAPE), but whether inflammation is also necessary or causal is less certain. Swenson and colleaguesArticle evaluated alpinists with previous mountaineering experience at low altitude (490 m) and after an ascent to a research laboratory at high altitude (4559 m). Most of the participants with a prior history of HAPE (HAPE-susceptible) developed HAPE before or at the time of the high-altitude evaluation, but none of the HAPE-resistant participants developed HAPE. At high altitude, pulmonary artery systolic pressures were significantly higher than at low altitude in both groups and higher in HAPE-susceptible compared with HAPE-resistant participants, but total leukocyte counts and leukocyte differential percentages in bronchoalveolar lavage fluid were not significantly different from low-altitude levels or between groups at low or high altitude. In an editorial, Hackett and RennieArticle discuss the implications of this study for prevention and treatment of HAPE.

Dignity-Conserving Care for Dying Patients

Dignity-conserving care explicitly targets preservation of dignity as a therapeutic goal and as a principle of palliative care for patients nearing death. Segments of interviews with a 62-year-old man with advanced lung cancer, his wife, and his palliative care physician illustrate aspects of dignity-conserving care and the model on which it is based.

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A Piece of My Mind

"Inside I realized I really didn't know exactly what I wanted, much less how to achieve it. My prolonged academic training had resulted in my always looking to others for praise and direction." From "The Music I Want to Hear."

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Medical News & Perspectives

Recent data suggest that the incidence of malignant melanoma in the United States is continuing to rise in all age groups and that the increase is real, not simply a reflection of improved detection.

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Anthrax as a Biological Weapon, 2002

The Working Group on Civilian Biodefense includes an analysis of the anthrax attacks in the United States in 2001 in this update of the 1999 consensus statement on medical and public health management after the use of Bacillus anthracis as a bioweapon.

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How to use the clinical history, physical examination, and plain chest radiograph to assess whether a patient has acute thoracic aortic dissection.

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Global warming and human health.

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JAMA Patient Page

For your patients: Information about high-altitude illness.

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