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Showing posts with label Echocardiography. Show all posts
Showing posts with label Echocardiography. Show all posts
Friday, March 4, 2011
Saturday, October 13, 2007
Deaths Prompt New Warnings for Micro-Bubble Contrast Agents
Deaths Prompt New Warnings for Micro-Bubble Contrast Agents
By Crystal Phend, Staff Writer, MedPage TodayOctober 12, 2007
ROCKVILLE, Md., Oct. 12 -- Eleven deaths and nearly 200 reports of serious cardiopulmonary events have been linked to microbubble contrast agents (Definity and Optison) used in echocardiography, the FDA reported today.
DuPont Pharmaceuticals, maker of Definity, and GE Healthcare, maker of Optison, agreed to labeling changes emphasizing the risk for serious cardiopulmonary reactions and contraindication for use in patients with unstable cardiopulmonary status, said the agency.
Most of the deaths occurred within 12 hours of administration among patients with severe underlying conditions. In four cases, patients died after cardiac arrest within 30 minutes of receiving Definity.
Many of the 190 serious non-fatal reactions reported with Definity and nine reports with Optison also occurred within minutes of administration and were suggestive of anaphylactic or cardiopulmonary reactions, the FDA said.
The labeling changes included:
A boxed warning for cardiopulmonary reactions.
Warnings for cardiopulmonary and hypersensitivity reactions with recommendations to monitor vital signs, cardiac rhythm, oxygen saturation and to have equipment and trained personnel readily available for resuscitation.
Contraindications for high-risk patients, specifically those with known cardiac shunts, clinically unstable or recent worsening of congestive heart failure, symptomatic arrhythmias or at elevated risk for arrhythmias.
A cautionary statement that the safety and efficacy of Definity in exercise or pharmacological stress testing have not been established.
The manufacturers will conduct a postmarketing safety study to monitor risk of serious cardiovascular reactions, the FDA said.
Meanwhile, the FDA suggested that physicians should monitor all patients receiving these contrast agents for serious cardiopulmonary reactions during infusion and for 30 minutes after administration.
The FDA also recommended that all patients should be assessed for the following conditions before use:
Right-to-left, bi-directional, or transient right-to-left cardiac shunts
Clinically unstable or recent worsening congestive heart failure.
Acute myocardial infarction.
Serious ventricular arrhythmias or at high risk for arrhythmias due to QT prolongation.
Respiratory failure.
Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature.
By Crystal Phend, Staff Writer, MedPage TodayOctober 12, 2007
ROCKVILLE, Md., Oct. 12 -- Eleven deaths and nearly 200 reports of serious cardiopulmonary events have been linked to microbubble contrast agents (Definity and Optison) used in echocardiography, the FDA reported today.
DuPont Pharmaceuticals, maker of Definity, and GE Healthcare, maker of Optison, agreed to labeling changes emphasizing the risk for serious cardiopulmonary reactions and contraindication for use in patients with unstable cardiopulmonary status, said the agency.
Most of the deaths occurred within 12 hours of administration among patients with severe underlying conditions. In four cases, patients died after cardiac arrest within 30 minutes of receiving Definity.
Many of the 190 serious non-fatal reactions reported with Definity and nine reports with Optison also occurred within minutes of administration and were suggestive of anaphylactic or cardiopulmonary reactions, the FDA said.
The labeling changes included:
A boxed warning for cardiopulmonary reactions.
Warnings for cardiopulmonary and hypersensitivity reactions with recommendations to monitor vital signs, cardiac rhythm, oxygen saturation and to have equipment and trained personnel readily available for resuscitation.
Contraindications for high-risk patients, specifically those with known cardiac shunts, clinically unstable or recent worsening of congestive heart failure, symptomatic arrhythmias or at elevated risk for arrhythmias.
A cautionary statement that the safety and efficacy of Definity in exercise or pharmacological stress testing have not been established.
The manufacturers will conduct a postmarketing safety study to monitor risk of serious cardiovascular reactions, the FDA said.
Meanwhile, the FDA suggested that physicians should monitor all patients receiving these contrast agents for serious cardiopulmonary reactions during infusion and for 30 minutes after administration.
The FDA also recommended that all patients should be assessed for the following conditions before use:
Right-to-left, bi-directional, or transient right-to-left cardiac shunts
Clinically unstable or recent worsening congestive heart failure.
Acute myocardial infarction.
Serious ventricular arrhythmias or at high risk for arrhythmias due to QT prolongation.
Respiratory failure.
Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature.
Bristol-Myers Strengthens Warning on Ultrasound Drug
Bristol-Myers Strengthens Warning on Ultrasound Drug (Update2)
By Beth Jinks
Oct. 11 (Bloomberg) -- Bristol-Myers Squibb Co. strengthened the warning on its drug Definity, used to enhance heart images from ultrasound scans, after a U.S. inquiry into the medicine's safety.
The new prescribing information, highlighted in a black box on the package insert and warning of the risk of "serious cardiopulmonary reactions,'' was posted today on the Food and Drug Administration's Web site. The black box represents the agency's most serious safety caution.
The FDA said Oct. 8 that regulators would soon alert health-care professionals of serious risks and new safety guidelines in using the agents Definity and Optison before echocardiography, a form of ultrasound used to diagnose heart ailments.
Bristol-Myers, which makes Definity, and General Electric Co., which sells Optison, confirmed this week they were discussing package insert revisions with regulators. The safety information for Optison was unchanged on the FDA Web site today.
“The changes are designed to help ensure the safe and appropriate use of Definity,'' Bristol-Myers spokesman Tony Plohoros said. ``We believe that Definity still has significant medical value when used properly and in accordance with the label.''
Bristol-Myers will send doctors FDA-approved letters when "the changes are final,'' Plohoros said. Sales of Definity were $65 million in the U.S. last year and less than $1 million abroad, company spokesman Jeffrey Macdonald said Oct. 8.
New Alert
Definity's new boxed alert warns that "serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration,'' advising that patients be closely monitored and resuscitation equipment be on hand for half an hour after injecting the drug.
Bristol-Myers fell 13 cents to $29.50 at the 4 p.m. close in New York Stock Exchange composite trading. General Electric fell 21 cents to $41.60.
Definity, approved by the FDA in 2001, and Optison, allowed since 1997, enhance ultrasound images to help doctors see the heart more clearly. The drugs are a gas enclosed in small capsules of protein or fatty material that make heart borders clearer, letting doctors rule out small clots and identify abnormalities on the heart wall.
“FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were given'' the drugs, Karen Riley, an FDA spokeswoman, said Oct. 8. “FDA has also asked manufacturers to update their product labeling and they have agreed to do so.''
“We are currently working with the FDA on how this should be implemented for Optison,'' Graeme Holland, a GE spokesman, said Oct. 8. "To date more than 1 million doses of Optison have been given, and very few adverse reactions have been reported.''
To contact the reporter on this story: Beth Jinks in New York at bjinks1@bloomberg.net
Last Updated: October 11, 2007 16:51 EDT
By Beth Jinks
Oct. 11 (Bloomberg) -- Bristol-Myers Squibb Co. strengthened the warning on its drug Definity, used to enhance heart images from ultrasound scans, after a U.S. inquiry into the medicine's safety.
The new prescribing information, highlighted in a black box on the package insert and warning of the risk of "serious cardiopulmonary reactions,'' was posted today on the Food and Drug Administration's Web site. The black box represents the agency's most serious safety caution.
The FDA said Oct. 8 that regulators would soon alert health-care professionals of serious risks and new safety guidelines in using the agents Definity and Optison before echocardiography, a form of ultrasound used to diagnose heart ailments.
Bristol-Myers, which makes Definity, and General Electric Co., which sells Optison, confirmed this week they were discussing package insert revisions with regulators. The safety information for Optison was unchanged on the FDA Web site today.
“The changes are designed to help ensure the safe and appropriate use of Definity,'' Bristol-Myers spokesman Tony Plohoros said. ``We believe that Definity still has significant medical value when used properly and in accordance with the label.''
Bristol-Myers will send doctors FDA-approved letters when "the changes are final,'' Plohoros said. Sales of Definity were $65 million in the U.S. last year and less than $1 million abroad, company spokesman Jeffrey Macdonald said Oct. 8.
New Alert
Definity's new boxed alert warns that "serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration,'' advising that patients be closely monitored and resuscitation equipment be on hand for half an hour after injecting the drug.
Bristol-Myers fell 13 cents to $29.50 at the 4 p.m. close in New York Stock Exchange composite trading. General Electric fell 21 cents to $41.60.
Definity, approved by the FDA in 2001, and Optison, allowed since 1997, enhance ultrasound images to help doctors see the heart more clearly. The drugs are a gas enclosed in small capsules of protein or fatty material that make heart borders clearer, letting doctors rule out small clots and identify abnormalities on the heart wall.
“FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were given'' the drugs, Karen Riley, an FDA spokeswoman, said Oct. 8. “FDA has also asked manufacturers to update their product labeling and they have agreed to do so.''
“We are currently working with the FDA on how this should be implemented for Optison,'' Graeme Holland, a GE spokesman, said Oct. 8. "To date more than 1 million doses of Optison have been given, and very few adverse reactions have been reported.''
To contact the reporter on this story: Beth Jinks in New York at bjinks1@bloomberg.net
Last Updated: October 11, 2007 16:51 EDT
Thursday, October 11, 2007
Ultrasound Imaging Drug Gets Black-Box Warning
Ultrasound Imaging Drug Gets Black-Box Warning
October 11, 2007
Posted by Jacob Goldstein
The FDA posted a black-box warning added to Definity, a Bristol-Myers Squibb drug used in conjunction with ultrasound imaging to diagnose heart problems, Dow Jones Newswires reports.
The Health Blog reported on Sunday that the agency has been investigating reports of deaths and serious side effects associated with the drug, and that the warning was imminent.
The warning says: “Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY administration.” It also says patients should be assessed for risk factors that make the drug unsafe, and patients who do receive the drug should be monitored for 30 minutes. The warning ends with an imperative: “Always have resuscitation equipment and trained personnel readily available.”
The drug is also contraindicated for patients with worsening or clinically unstable congestive heart failure and acute myocardial infarction or acute coronary syndromes.
Most echocardiograms are performed without the drug, but doctors sometimes use it when a first ultrasound is inconclusive or in difficult cases.
The stiffer warnings are expected to reduce the use of Definity, several cardiologists told the Health Blog.
October 11, 2007
Posted by Jacob Goldstein
The FDA posted a black-box warning added to Definity, a Bristol-Myers Squibb drug used in conjunction with ultrasound imaging to diagnose heart problems, Dow Jones Newswires reports.
The Health Blog reported on Sunday that the agency has been investigating reports of deaths and serious side effects associated with the drug, and that the warning was imminent.
The warning says: “Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY administration.” It also says patients should be assessed for risk factors that make the drug unsafe, and patients who do receive the drug should be monitored for 30 minutes. The warning ends with an imperative: “Always have resuscitation equipment and trained personnel readily available.”
The drug is also contraindicated for patients with worsening or clinically unstable congestive heart failure and acute myocardial infarction or acute coronary syndromes.
Most echocardiograms are performed without the drug, but doctors sometimes use it when a first ultrasound is inconclusive or in difficult cases.
The stiffer warnings are expected to reduce the use of Definity, several cardiologists told the Health Blog.
Saturday, August 4, 2007
Prevalence of Rheumatic Heart Disease Detected by Echocardiographic Screening
Prevalence of Rheumatic Heart Disease Detected by Echocardiographic Screening
NEJM - Volume 357:470-476
ABSTRACT
Background Epidemiologic studies of the prevalence of rheumatic heart disease have used clinical screening with echocardiographic confirmation of suspected cases. We hypothesized that echocardiographic screening of all surveyed children would show a significantly higher prevalence of rheumatic heart disease.
Methods Randomly selected schoolchildren from 6 through 17 years of age in Cambodia and Mozambique were screened for rheumatic heart disease according to standard clinical and echocardiographic criteria.
Results Clinical examination detected rheumatic heart disease that was confirmed by echocardiography in 8 of 3677 children in Cambodia and 5 of 2170 children in Mozambique; the corresponding prevalence rates and 95% confidence intervals (CIs) were 2.2 cases per 1000 (95% CI, 0.7 to 3.7) for Cambodia and 2.3 cases per 1000 (95% CI, 0.3 to 4.3) for Mozambique. In contrast, echocardiographic screening detected 79 cases of rheumatic heart disease in Cambodia and 66 cases in Mozambique, corresponding to prevalence rates of 21.5 cases per 1000 (95% CI, 16.8 to 26.2) and 30.4 cases per 1000 (95% CI, 23.2 to 37.6), respectively. The mitral valve was involved in the great majority of cases (87.3% in Cambodia and 98.4% in Mozambique).
Conclusions Systematic screening with echocardiography, as compared with clinical screening, reveals a much higher prevalence of rheumatic heart disease (approximately 10 times as great). Since rheumatic heart disease frequently has devastating clinical consequences and secondary prevention may be effective after accurate identification of early cases, these results have important public health implications.
Tuesday, July 3, 2007
Surprise Findings on Obesity and Heart Attacks
Patterns: In Studies, Surprise Findings on Obesity and Heart Attacks
Published: July 3, 2007
Two new studies shed light on the role obesity may play in causing heart attacks and, surprisingly, keeping them from being fatal.
The Impact of Obesity on Mortality in UA/non-ST-segment Elevation Myocardial Infarction (European Heart Journal)
In one study, published by the European Heart Journal, researchers followed more than 1,600 patients who were given angioplasty and, usually, stents after a type of heart attack known as unstable angina/non-ST-segment elevation. They found that the obese and very obese patients were only half as likely as those of normal weight to die in the three years after the attack.
Part of the explanation may be that obese people are more likely to have their heart problems detected by doctors and treated with medications that later help them recover from heart attacks.
Heart attack patients who are obese also tend to be younger. And other changes in the body that often occur with obesity may also help, the study said. (Of course, as the researchers noted, obesity is not desirable when it comes to heart disease; it causes medical problems that can lead to heart attacks in the first place.)
In the second study, presented at a recent meeting of the American Society of Echocardiography, researchers reported that excess weight was associated with a thickening of muscle in the left ventricle, the part of the heart that acts as a pump.
The study was led by researchers from the University of Arizona Sarver Heart Center.
Published: July 3, 2007
Two new studies shed light on the role obesity may play in causing heart attacks and, surprisingly, keeping them from being fatal.
The Impact of Obesity on Mortality in UA/non-ST-segment Elevation Myocardial Infarction (European Heart Journal)
In one study, published by the European Heart Journal, researchers followed more than 1,600 patients who were given angioplasty and, usually, stents after a type of heart attack known as unstable angina/non-ST-segment elevation. They found that the obese and very obese patients were only half as likely as those of normal weight to die in the three years after the attack.
Part of the explanation may be that obese people are more likely to have their heart problems detected by doctors and treated with medications that later help them recover from heart attacks.
Heart attack patients who are obese also tend to be younger. And other changes in the body that often occur with obesity may also help, the study said. (Of course, as the researchers noted, obesity is not desirable when it comes to heart disease; it causes medical problems that can lead to heart attacks in the first place.)
In the second study, presented at a recent meeting of the American Society of Echocardiography, researchers reported that excess weight was associated with a thickening of muscle in the left ventricle, the part of the heart that acts as a pump.
The study was led by researchers from the University of Arizona Sarver Heart Center.
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