The FDA has approved new labeling for mifepristone (Mifeprex), also known as RU-486, the drug that is used for ending early pregnancies. "The labeling changes include revisions to the Prescribing Information, Patient Medication Guide, Patient Agreement Form and Prescriber Agreement Form to reflect the most current clinical practices and safety and efficacy data for Mifeprex," Danco Laboratories, the drug's maker, said in a press release.
The labeling changes include:
This labeling change "is another affirmation from the FDA that medication abortion is a safe and effective option to end an early pregnancy," said Raegan McDonald-Mosley, MD, chief medical officer of Planned Parenthood Federation of America, in a statement. "Until today, the regimen outlined on mifepristone's final printing label approved by the FDA was based on clinical trials completed in the mid-1990s," McDonald-Mosley continued. "Numerous subsequent studies have demonstrated the safety and effectiveness of a regimen using a lower dosage of mifepristone that can also be used two weeks later in pregnancy, up to 70 days since a woman's last menstrual period. This new regimen has been recognized by the American Medical Association and the American College of Obstetricians and Gynecologists as 'superior' to the regimen on the previous FDA-approved label." Mifeprex was approved by the FDA in 2000 and has been found to be about 97% effective in terminating early pregnancy, the company noted.
An FDA advisory panel has agreed overwhelmingly that evidence does not support some indications for systemic fluoroquinolone antibiotics. Data on the risks and benefits of the drugs do not support their use in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients with COPD, or uncomplicated urinary tract infections, members of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in joint session agreed. What the FDA might do with the advice is uncertain, although the vote certainly raises the likelihood of new label language concerning use of fluoroquinolones for these indications, perhaps even revoking approval for these indications. The FDA is not obliged to accept the advice of its committees but usually does. The fluoroquinolones - mainly ciprofloxacin, levofloxacin, and moxifloxacin - have been indicated for some or all of the three disease entities for several years but there is rising concern that they are being used inappropriately, putting patients at risk for often serious side effects, the panel was told.In those indications, guidelines recommend them for second-line use --in patients for whom other therapy is contraindicated - as long as the bacterial etiology is established. But the drugs have known adverse events flagged in their labels, including tendinopathy, cardiac arrhythmias, and peripheral neuropathy.
Which radiologic test should be ordered first for the evaluation of suspected urolithiasis in the pediatric age group?
Answer: Although not as accurate as computerized tomography (CT), ultrasound (US) identified almost all clinically important renal stones in children presenting with suspected urolithiasis. The benefits of US include no ionizing radiation and lower costs. Stronger evidence from a randomized trial comparing outcomes from similar children initially undergoing either US or CT scanning is needed before setting a standard of practice.
MAXALT is a selective 5HT1B/1D receptor agonist indicated
for the acute treatment of migraine attacks with or without aura in adults.
MAXALT is not intended for the prophylactic therapy of migraine or for use in
the management of hemiplegic or basilar migraine. Safety and effectiveness of
MAXALT have not been established for cluster headache, which is present in an
older, predominantly male population. MAXALT is available in 5 and 10 mg doses
in a tablet or orally dissolving wafer formulation. Individuals may vary in
responses to doses of MAXALT-MLT Tablets. There is evidence that the 10 mg dose
may provide a greater effect than the 5 mg dose. The choice of dose should
therefore be made on an individual basis, weighing the possible benefit of the
10 mg dose with the potential risk for increased adverse events. In patients
taking propranolol, the 5 mg dose should be used. Patients may take up to 3
doses within any 24-hour period, with doses separated by at least 2 hours.
MAXAL-MLT contains phenylalanine. For more information, visit www.maxalt.com.
The Ottawa knee rule was developed
by researchers at the University of Ottawa who were concerned about possible
overuse of radiography in the evaluation of knee injuries. They conducted a
retrospective study of 1,967 patients who presented with acute knee injury at
three hospital emergency departments over a 12-month period and a prospective
survey of another 1.040 patients seen by attending emergency physicians. The
result was a list of criteria, the presence of any one of which was considered
evidence of fracture and the need for radiographic examination. These criteria
The Ottawa knee rule has been found to be 100% sensitive and 43% specific for
the presence of fracture. Use of the rule can reduce unnecessary use of
radiography in patients with knee injuries.
Two compendia, Acute Respiratory Tract Infection
Guideline Summaries for Adults and Pediatrics were designed by the CMA
Foundation to summarize appropriate antibiotic treatment of common adult and
pediatric infections. The AAUCM endorses and supports this effort. To view and
print the Adult Acute Respiratory Tract Infection Guideline Summary, click
here. To view and print the Pediatric Acute Respiratory Tract Infection
Guideline Summary, click here. For more information, visit www.aware.md.
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