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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drugs acquired a new black box warning or were withdrawn between 1975 and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.
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.
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
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.
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.
How to use the clinical history, physical examination, and plain chest
radiograph to assess whether a patient has acute thoracic aortic dissection.
Global warming and human health.
JAMA Patient Page
For your patients: Information about high-altitude illness.
This Week in JAMA. JAMA. 2002;287(17):2179. doi:10.1001/jama.287.17.2179
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