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Adverse Events

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NEWS
By Delthia Ricks and Delthia Ricks,NEWSDAY | May 24, 2005
NEW YORK - Despite government assurances that the popular cholesterol-lowering drug Crestor is safe, a new report has raised questions about the medication, saying it produces double the adverse reactions of others in its class. A new Crestor investigation, which analyzes adverse events reported to the Food and Drug Administration, said the statin should be used only in instances when other statins fail to appropriately lower LDL, the bad form of cholesterol. Adverse events are reported to the FDA by health care providers and patient advocates, and the information is maintained in a database.
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NEWS
By Ben Steffen, Donna Kinzer and Patricia Tomsko Nay | August 7, 2014
A recent Baltimore Sun article ("Maryland hospitals aren't reporting all errors and complications, experts say," July 26) focused on the benefit of facility-specific adverse medical event reporting to state regulators to improve patient safety, enhance consumer decision making and increase health care facility accountability. The article noted that reporting of "adverse events" — including wrong site surgery, surgeries on the wrong person, medication errors and assaults on patients — is not made public in Maryland.
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NEWS
By JULIE BELL and JULIE BELL,SUN REPORTER | September 30, 2005
Many Maryland hospitals are not complying with a law that requires them to tell the state when patients are seriously disabled or die after unexpected events such as medical mistakes, a state analysis concludes. The state's Office of Health Care Quality also found that even hospitals reporting the injuries often do so late and may be keeping patients and their families in the dark. "There needs to be a culture change at hospitals," said Carol Benner, who officially retired yesterday as director of the health care quality agency after earlier handing over day-to-day duties to acting director Wendy Kronmiller.
NEWS
By Kelly Brewington and Kelly Brewington,kelly.brewington@baltsun.com | October 8, 2008
The makers of cold and cough medicines said yesterday that they will stop marketing over-the-counter remedies to children under 4 - acting amid an extensive federal review of whether the drugs are safe and effective for children under 12. The voluntary decision comes two years after Baltimore Health Commissioner Dr. Joshua M. Sharfstein and a group of leading pediatricians petitioned the U.S. Food and Drug Administration to stop the sale of the medicines...
NEWS
By Tom Pelton and Tom Pelton,SUN STAFF | August 12, 2001
Are volunteers hurt or killed in medical experiments more often than scientists acknowledge? The question has been percolating in laboratories across the United States since investigations into a healthy woman's death in a Johns Hopkins asthma experiment turned up suggestions that two previous illnesses involving the same chemical might have been improperly concealed. Scholars and federal officials say it's inherently difficult to measure how often problems are not reported. But many say there's enough anecdotal evidence from lawsuits and complaints to suggest that the nation's system for monitoring "adverse events" during experiments should be improved.
NEWS
By Julie Bell and Julie Bell,SUN STAFF | September 14, 2003
Soon after Cecilia Green's face caught fire during minor surgery, a shaken Dr. Prakash Vaidyanathan walked out of the operating room to explain what had happened to Green's waiting friend. Later, the surgeon carefully dictated the details for Green's medical chart, explaining that he had already removed the small lesion on her forehead when a cauterizing tool he was using to stop the bleeding singed an eyebrow, touching off a blaze fed by Green's oxygen mask. "The whole face had caught on fire," he noted.
NEWS
By Ricardo Alonso-Zaldivar and Ricardo Alonso-Zaldivar,LOS ANGELES TIMES | May 22, 2008
WASHINGTON - The Federal Aviation Administration banned pilots and air traffic controllers yesterday from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that posed risks to both users and others. The drug, marketed as Chantix, has been hailed as an innovative treatment to help smokers quit. But a study by a medical safety group - also issued yesterday - linked it to a variety of unusual and serious side effects, including loss of consciousness and seizures, and prompted the FAA to act, said spokesman Les Dorr.
NEWS
By Edward Roeder | October 21, 2001
"In Cipro we trust" -- NBC anchor Tom Brokaw WASHINGTON -- As thousands of congressional aides and visitors were given nasal swab tests for anthrax last week after an envelope containing anthrax was opened in a Senate office, the attending Capitol physician announced, "If we screen you, we treat you." This means a course of the antibiotic Ciprofloxacin, commonly called, sought and today hoarded under the brand name Cipro. But thousands of doses of Cipro will lead to hundreds of serious and unnecessary harmful side effects.
BUSINESS
By Tricia Bishop and Tricia Bishop,sun reporter | June 8, 2007
Human Genome Sciences Inc. reported clinical trial data yesterday showing that Albuferon, a hepatitis C drug the Rockville biotech is developing, is comparable to a current therapy and may do less damage to patients' quality of life during treatment. It also had a benefit of particular interest in the United States, where a large percentage of patients are overweight: The drug appeared to work better in heavier people than its alternative, a drug called Pegasys made by Hoffmann-La Roche Inc. But Albuferon, one of two drugs the company is relying on for eventual revenue, also had higher rates of patient discontinuation because of adverse events - particularly at the higher dosing levels.
NEWS
By Kelly Brewington and Kelly Brewington,kelly.brewington@baltsun.com | October 8, 2008
The makers of cold and cough medicines said yesterday that they will stop marketing over-the-counter remedies to children under 4 - acting amid an extensive federal review of whether the drugs are safe and effective for children under 12. The voluntary decision comes two years after Baltimore Health Commissioner Dr. Joshua M. Sharfstein and a group of leading pediatricians petitioned the U.S. Food and Drug Administration to stop the sale of the medicines...
NEWS
By Ricardo Alonso-Zaldivar and Ricardo Alonso-Zaldivar,LOS ANGELES TIMES | May 22, 2008
WASHINGTON - The Federal Aviation Administration banned pilots and air traffic controllers yesterday from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that posed risks to both users and others. The drug, marketed as Chantix, has been hailed as an innovative treatment to help smokers quit. But a study by a medical safety group - also issued yesterday - linked it to a variety of unusual and serious side effects, including loss of consciousness and seizures, and prompted the FAA to act, said spokesman Les Dorr.
BUSINESS
By Tricia Bishop and Tricia Bishop,sun reporter | June 8, 2007
Human Genome Sciences Inc. reported clinical trial data yesterday showing that Albuferon, a hepatitis C drug the Rockville biotech is developing, is comparable to a current therapy and may do less damage to patients' quality of life during treatment. It also had a benefit of particular interest in the United States, where a large percentage of patients are overweight: The drug appeared to work better in heavier people than its alternative, a drug called Pegasys made by Hoffmann-La Roche Inc. But Albuferon, one of two drugs the company is relying on for eventual revenue, also had higher rates of patient discontinuation because of adverse events - particularly at the higher dosing levels.
NEWS
By JONATHAN D. ROCKOFF and JONATHAN D. ROCKOFF,SUN REPORTER | December 1, 2005
WASHINGTON -- Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users yesterday and said the fatal infection that caused the deaths wasn't particular to women taking the drug. In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as "low" and said it could occur after a woman has taken the pill, undergone a surgical abortion or given birth.
NEWS
By JULIE BELL and JULIE BELL,SUN REPORTER | September 30, 2005
Many Maryland hospitals are not complying with a law that requires them to tell the state when patients are seriously disabled or die after unexpected events such as medical mistakes, a state analysis concludes. The state's Office of Health Care Quality also found that even hospitals reporting the injuries often do so late and may be keeping patients and their families in the dark. "There needs to be a culture change at hospitals," said Carol Benner, who officially retired yesterday as director of the health care quality agency after earlier handing over day-to-day duties to acting director Wendy Kronmiller.
NEWS
By Delthia Ricks and Delthia Ricks,NEWSDAY | May 24, 2005
NEW YORK - Despite government assurances that the popular cholesterol-lowering drug Crestor is safe, a new report has raised questions about the medication, saying it produces double the adverse reactions of others in its class. A new Crestor investigation, which analyzes adverse events reported to the Food and Drug Administration, said the statin should be used only in instances when other statins fail to appropriately lower LDL, the bad form of cholesterol. Adverse events are reported to the FDA by health care providers and patient advocates, and the information is maintained in a database.
NEWS
By Julie Bell and Julie Bell,SUN STAFF | September 14, 2003
Soon after Cecilia Green's face caught fire during minor surgery, a shaken Dr. Prakash Vaidyanathan walked out of the operating room to explain what had happened to Green's waiting friend. Later, the surgeon carefully dictated the details for Green's medical chart, explaining that he had already removed the small lesion on her forehead when a cauterizing tool he was using to stop the bleeding singed an eyebrow, touching off a blaze fed by Green's oxygen mask. "The whole face had caught on fire," he noted.
NEWS
By JONATHAN D. ROCKOFF and JONATHAN D. ROCKOFF,SUN REPORTER | December 1, 2005
WASHINGTON -- Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users yesterday and said the fatal infection that caused the deaths wasn't particular to women taking the drug. In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as "low" and said it could occur after a woman has taken the pill, undergone a surgical abortion or given birth.
NEWS
By Ben Steffen, Donna Kinzer and Patricia Tomsko Nay | August 7, 2014
A recent Baltimore Sun article ("Maryland hospitals aren't reporting all errors and complications, experts say," July 26) focused on the benefit of facility-specific adverse medical event reporting to state regulators to improve patient safety, enhance consumer decision making and increase health care facility accountability. The article noted that reporting of "adverse events" — including wrong site surgery, surgeries on the wrong person, medication errors and assaults on patients — is not made public in Maryland.
NEWS
By Edward Roeder | October 21, 2001
"In Cipro we trust" -- NBC anchor Tom Brokaw WASHINGTON -- As thousands of congressional aides and visitors were given nasal swab tests for anthrax last week after an envelope containing anthrax was opened in a Senate office, the attending Capitol physician announced, "If we screen you, we treat you." This means a course of the antibiotic Ciprofloxacin, commonly called, sought and today hoarded under the brand name Cipro. But thousands of doses of Cipro will lead to hundreds of serious and unnecessary harmful side effects.
NEWS
By Tom Pelton and Tom Pelton,SUN STAFF | August 12, 2001
Are volunteers hurt or killed in medical experiments more often than scientists acknowledge? The question has been percolating in laboratories across the United States since investigations into a healthy woman's death in a Johns Hopkins asthma experiment turned up suggestions that two previous illnesses involving the same chemical might have been improperly concealed. Scholars and federal officials say it's inherently difficult to measure how often problems are not reported. But many say there's enough anecdotal evidence from lawsuits and complaints to suggest that the nation's system for monitoring "adverse events" during experiments should be improved.
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