News & Analysis
professor emeritus of radiology and vicechairman for quality improvement and patient safety at the University of Alabama at Birmingham, said the ACR was “fairly pleased” with the commission’s report but did say it was unrealistic to discuss all incidentalandsecondaryfindingswithapatient who requests such a discussion. “It would functionally change how imaging is done. I may read 30 to 40 exams a day, and if I had to discuss every incidental finding it would cut down by half the number of procedures I can do,” Berland said. “Many radiologists are not putting incidental findings into a report because
if you tell a patient about everything, it can be very distracting from a time perspective, taking time away from a discussion about the real problem the patient came in for,” he said. “Following up on many of these incidental findings can do more harm than good, like getting more x-rays and undergoing biopsies.” The commission’s report, “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-toConsumer Contexts,” is available online at http://1.usa.gov/J0qHzR.
FDA Asks Physicians to Stop Prescribing High-Dose Acetaminophen Products Mike Mitka, MSJ
RapidEye/iStock.com
A
fter only limited success in persuading drug manufacturers to reduce the amount of the painkiller acetaminophen in prescription combination products, the US Food and Drug Administration (FDA) has now called on physicians to avoid prescribing these products if the acetaminophen content is too high. Liver failure, a need for liver transplantation, or death can occur when individuals exceed a certain daily dosage. In 2011, the FDA gave manufacturers 3 years to voluntarily limit the amount of acetaminophen in prescription combination drugstonomorethan325mgineachtablet or capsule. The 3-year window closed January14,andalthoughmorethanhalfofmanufacturers have complied, some have not. Acetaminophen, used to relieve pain and fever, can be found in over-thecounter products, such as Tylenol, and in prescription products combined with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). Severe liver injury can occur when acetaminophen use exceeds maximum dosage (currently 4000 mg within a 24hour period) or when an individual takes the drug and also consumes alcohol. Researchers estimate that in the United States, there are about 44 000 acetaminophen overdose–related emergency department visits each year, with about half being unintentional.
On January 14, the FDA issued a recommendation to physicians and other healthcareprofessionalstodiscontinueprescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per dosage unit. The agency noted that there are noavailabledatashowingthattakinghigher doses per pill or tablet provides additional benefit that outweighs the added risks for liver injury. This limitation should help reduce the risk of severe liver injury from inadvertent acetaminophen overdose. The FDA said that it will soon begin proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market. The FDA’s action last month does not apply to products sold over the counter that contain acetaminophen as the sole active ingredient or combined with other drugs, such as ingredients found in cough and cold medicine. ProPublica, an independent, nonprofit news group, pointed out that some over-the-counter products contain as much as 625 mg of acetaminophen per dose (http://bit.ly /1ar5vAr). However, the agency said it will address over-the-counter acetaminophen products in another regulatory action because many consumers are unaware that overuse of acetaminophen poses a liver damage risk.
jama.com
news@JAMA FROM JAMA’S DAILY NEWS SITE
Early Sign of Autism in Infants An early sign of autism—declining eye contact—may be detected in infants as young as just a few months old, according to a recent study. Researchers studied 110 infants, about half who were at high risk of developing autism spectrum disorder (ASD) and half who were at low risk. The investigators used eye-tracking equipment to measure the infants’ visual scanning. Infants who eventually were diagnosed with ASD had declining eye contact beginning at the age of 2 months. By age 2 years, their ability to make eye contact was about half that of children who didn’t develop ASD. http://jama.md/1m6H1ir Does Lost Sleep Leave Surgeons Impaired? Recent findings suggest that sleep deprivation among surgeons may be more benign than previously suspected. Researchers noted complications in 2078 nonemergency cholecystectomies that surgeons performed during the day after they also had performed emergency surgery the night; each procedure was compared with 4 control cholecystectomies that the same surgeon performed when he or she hadn’t operated during the previous night. Rates of the main complication—converting a standard laparoscopic procedure to an open procedure with an abdominal incision—didn’t vary based on whether surgeons had operated overnight. http://jama.md/17SKVp8 Heart Disease Guidelines Finally Published Long-awaited national guidelines to reduce most cardiovascular disease risk factors focus on healthy lifestyles, atherosclerotic cardiovascular risk assessment, blood cholesterol management, and obesity. The healthy lifestyles and risk assessment guidelines are new. Cholesterol management recommendations were last updated in 2004; the obesity guideline hadn’t been revised since 1998. Each guideline was created by expert panels convened by the National Heart, Lung, and Blood Institute, which handed over management of the guidelines to the Obesity Society, the American Heart Association, and the American College of Cardiology. http://jama.md/1m7LSNs
For more on these stories and other medical news, visit http://newsatjama.jama.com.
JAMA February 12, 2014 Volume 311, Number 6
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/21/2015
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professor emeritus of radiology and vicechairman for quality improvement and patient safety at the University of Alabama at Birmingham, said the ACR was “fairly pleased” with the commission’s report but did say it was unrealistic to discuss all incidentalandsecondaryfindingswithapatient who requests such a discussion. “It would functionally change how imaging is done. I may read 30 to 40 exams a day, and if I had to discuss every incidental finding it would cut down by half the number of procedures I can do,” Berland said. “Many radiologists are not putting incidental findings into a report because
if you tell a patient about everything, it can be very distracting from a time perspective, taking time away from a discussion about the real problem the patient came in for,” he said. “Following up on many of these incidental findings can do more harm than good, like getting more x-rays and undergoing biopsies.” The commission’s report, “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-toConsumer Contexts,” is available online at http://1.usa.gov/J0qHzR.
FDA Asks Physicians to Stop Prescribing High-Dose Acetaminophen Products Mike Mitka, MSJ
RapidEye/iStock.com
A
fter only limited success in persuading drug manufacturers to reduce the amount of the painkiller acetaminophen in prescription combination products, the US Food and Drug Administration (FDA) has now called on physicians to avoid prescribing these products if the acetaminophen content is too high. Liver failure, a need for liver transplantation, or death can occur when individuals exceed a certain daily dosage. In 2011, the FDA gave manufacturers 3 years to voluntarily limit the amount of acetaminophen in prescription combination drugstonomorethan325mgineachtablet or capsule. The 3-year window closed January14,andalthoughmorethanhalfofmanufacturers have complied, some have not. Acetaminophen, used to relieve pain and fever, can be found in over-thecounter products, such as Tylenol, and in prescription products combined with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). Severe liver injury can occur when acetaminophen use exceeds maximum dosage (currently 4000 mg within a 24hour period) or when an individual takes the drug and also consumes alcohol. Researchers estimate that in the United States, there are about 44 000 acetaminophen overdose–related emergency department visits each year, with about half being unintentional.
On January 14, the FDA issued a recommendation to physicians and other healthcareprofessionalstodiscontinueprescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per dosage unit. The agency noted that there are noavailabledatashowingthattakinghigher doses per pill or tablet provides additional benefit that outweighs the added risks for liver injury. This limitation should help reduce the risk of severe liver injury from inadvertent acetaminophen overdose. The FDA said that it will soon begin proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market. The FDA’s action last month does not apply to products sold over the counter that contain acetaminophen as the sole active ingredient or combined with other drugs, such as ingredients found in cough and cold medicine. ProPublica, an independent, nonprofit news group, pointed out that some over-the-counter products contain as much as 625 mg of acetaminophen per dose (http://bit.ly /1ar5vAr). However, the agency said it will address over-the-counter acetaminophen products in another regulatory action because many consumers are unaware that overuse of acetaminophen poses a liver damage risk.
jama.com
news@JAMA FROM JAMA’S DAILY NEWS SITE
Early Sign of Autism in Infants An early sign of autism—declining eye contact—may be detected in infants as young as just a few months old, according to a recent study. Researchers studied 110 infants, about half who were at high risk of developing autism spectrum disorder (ASD) and half who were at low risk. The investigators used eye-tracking equipment to measure the infants’ visual scanning. Infants who eventually were diagnosed with ASD had declining eye contact beginning at the age of 2 months. By age 2 years, their ability to make eye contact was about half that of children who didn’t develop ASD. http://jama.md/1m6H1ir Does Lost Sleep Leave Surgeons Impaired? Recent findings suggest that sleep deprivation among surgeons may be more benign than previously suspected. Researchers noted complications in 2078 nonemergency cholecystectomies that surgeons performed during the day after they also had performed emergency surgery the night; each procedure was compared with 4 control cholecystectomies that the same surgeon performed when he or she hadn’t operated during the previous night. Rates of the main complication—converting a standard laparoscopic procedure to an open procedure with an abdominal incision—didn’t vary based on whether surgeons had operated overnight. http://jama.md/17SKVp8 Heart Disease Guidelines Finally Published Long-awaited national guidelines to reduce most cardiovascular disease risk factors focus on healthy lifestyles, atherosclerotic cardiovascular risk assessment, blood cholesterol management, and obesity. The healthy lifestyles and risk assessment guidelines are new. Cholesterol management recommendations were last updated in 2004; the obesity guideline hadn’t been revised since 1998. Each guideline was created by expert panels convened by the National Heart, Lung, and Blood Institute, which handed over management of the guidelines to the Obesity Society, the American Heart Association, and the American College of Cardiology. http://jama.md/1m7LSNs
For more on these stories and other medical news, visit http://newsatjama.jama.com.
JAMA February 12, 2014 Volume 311, Number 6
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Western Oregon University User on 05/21/2015
563
