FDA issues warning over Hepatitis C drug
Army Times
By Patricia Kime
Staff writer
Posted : Thursday Dec 20, 2012
The Food and Drug Administration is warning patients receiving treatment for hepatitis C with a triple drug regimen using Incevik, or telepriver, to be aware of a potentially dangerous, even fatal skin reaction.
The FDA on Wednesday announced it has altered Incevik’s label to include stronger warnings after some patients died from complications after developing a serious rash while taking Incevik along with two other medications for hepatitis C.
More than 2,700 active duty service members were diagnosed with chronic hepatitis C between 2000 and 2010, according to Pentagon data.
The Veterans Health Administration system has 170,000 patients with chronic hepatitis C, and more than 4,800 VA patients are receiving some kind of combination drug therapy for Hepatitis C.
read more here
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Friday, December 21, 2012
Wednesday, July 1, 2009
Suicide Warning Issued for Chantix and Zyban
These drugs work fine for some people. I've written before how they helped an elderly aunt and uncle quit successfully. The warning should be taken seriously for anyone with a mental health issue. Especially troubling right now is that the military has said they want to crack down on smoking. If they want to use these products, fine, but they better be prepared to make sure they are paying close attention to the troops that take them.
Suicide Warning Issued for 2 Anti-Smoking Drugs
By GARDINER HARRIS
Published: July 1, 2009
WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular stop-smoking drugs should be watched closely for signs of serious mental illness, as reported suicides among the drugs’ users mount.
But officials emphasized that patients should not be scared away from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curt Rosebraugh, director of a drug evaluation office at the F.D.A. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
The F.D.A. required Pfizer and Glaxo to place so-called black box warnings — the agency’s most serious caution — on the prescribing information for both drugs. Both companies will be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses.
go here for more
http://www.nytimes.com/2009/07/02/health/02drug.html?_r=1&hp
Tuesday, June 30, 2009
FDA advisers vote to take Vicodin, Percocet off market
FDA advisers vote to take Vicodin, Percocet off market
Story Highlights
NEW: Panel votes to kill prescription drugs that combine acetaminophen, narcotics
Panel advises lower maximum doses of nonprescription acetaminophen drugs
Those drugs include Tylenol, NyQuil, Pamprin and Allerest
CDC estimates acetaminophen was the likely cause of most acute liver failures
(CNN) -- A government advisory panel voted Tuesday to recommend eliminating prescription drugs that combine acetaminophen with narcotics -- such as Vicodin and Percocet -- because of their risk for overdose and for severe liver injury.
Acetaminophen, found in drugs such as Tylenol, is one of the most commonly used drugs in the United States.
The panel, assembled by the Food and Drug Administration, voted 20 to 17 to advise the FDA to remove such prescription combination drugs from the market.
The group recommended that the FDA "send a clear message that there's a high likelihood of overdose from prescription narcotics and acetaminophen products," Dr. Sandra L. Kweder of the FDA's Office of New Drugs said at a news conference after Tuesday's meeting.
go here for more
http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing/index.html
Story Highlights
NEW: Panel votes to kill prescription drugs that combine acetaminophen, narcotics
Panel advises lower maximum doses of nonprescription acetaminophen drugs
Those drugs include Tylenol, NyQuil, Pamprin and Allerest
CDC estimates acetaminophen was the likely cause of most acute liver failures
(CNN) -- A government advisory panel voted Tuesday to recommend eliminating prescription drugs that combine acetaminophen with narcotics -- such as Vicodin and Percocet -- because of their risk for overdose and for severe liver injury.
Acetaminophen, found in drugs such as Tylenol, is one of the most commonly used drugs in the United States.
The panel, assembled by the Food and Drug Administration, voted 20 to 17 to advise the FDA to remove such prescription combination drugs from the market.
The group recommended that the FDA "send a clear message that there's a high likelihood of overdose from prescription narcotics and acetaminophen products," Dr. Sandra L. Kweder of the FDA's Office of New Drugs said at a news conference after Tuesday's meeting.
go here for more
http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing/index.html
Wednesday, October 1, 2008
Still want smaller government? Melamine tainted candy from China found in CT
Melamine-Tainted Candy Found In CT
Chemical Associated With Other Recalls, Commissioner Says
POSTED: 2:23 pm EDT October 1, 2008
HARTFORD, Conn. -- The Department of Consumer Protection warned consumers Wednesday not to eat "White Rabbit Creamy Candy," imported from China and distributed by Queensway Foods Company Inc. of Burlingame, Calif.
The candy was found on several Connecticut store shelves the week of Sept. 29 by agency food safety inspectors and removed, agency Commissioner Jerry Farrell Jr. said. Tests by the Connecticut Agriculture Experiment Station Laboratory have determined that the product contains melamine, he said.
Melamine has been associated recently with contaminated infant formula and other milk protein-containing products in China, as well as a major pet food recall last year. The chemical is used in plastics manufacturing and as an adulterant in foods to simulate protein.
go here for more
http://www.wfsb.com/health/17599817/detail.html
linked from CNN
Chemical Associated With Other Recalls, Commissioner Says
POSTED: 2:23 pm EDT October 1, 2008
HARTFORD, Conn. -- The Department of Consumer Protection warned consumers Wednesday not to eat "White Rabbit Creamy Candy," imported from China and distributed by Queensway Foods Company Inc. of Burlingame, Calif.
The candy was found on several Connecticut store shelves the week of Sept. 29 by agency food safety inspectors and removed, agency Commissioner Jerry Farrell Jr. said. Tests by the Connecticut Agriculture Experiment Station Laboratory have determined that the product contains melamine, he said.
Melamine has been associated recently with contaminated infant formula and other milk protein-containing products in China, as well as a major pet food recall last year. The chemical is used in plastics manufacturing and as an adulterant in foods to simulate protein.
go here for more
http://www.wfsb.com/health/17599817/detail.html
linked from CNN
Saturday, August 2, 2008
Company asks pharmacists, hospitals to return 65 drugs
Company asks pharmacists, hospitals to return drug
Associated Press
Published: Friday August 1, 2008
WASHINGTON -- A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities' standards.
A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC "revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices," according to a company statement issued Friday.
The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension.
Only pharmacies and hospitals should return the prescription drugs. Patients who may have the drug should continue to take them in accordance with their prescriptions, the Morristown, N.J. company said in a release. The company said that suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.
For more information on the recall, consumers can visit
(go here to see the list)
http://www.actavis.us/en/media+center/newsroom/articles/RecallFAQ.htm
Linked from RawStory
Associated Press
Published: Friday August 1, 2008
WASHINGTON -- A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities' standards.
A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC "revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices," according to a company statement issued Friday.
The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension.
Only pharmacies and hospitals should return the prescription drugs. Patients who may have the drug should continue to take them in accordance with their prescriptions, the Morristown, N.J. company said in a release. The company said that suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.
For more information on the recall, consumers can visit
(go here to see the list)
http://www.actavis.us/en/media+center/newsroom/articles/RecallFAQ.htm
Linked from RawStory
Tuesday, June 17, 2008
VA $30 lab rats and Chantix
VA testing drugs on war veterans
Experiments raise ethical questions
Audrey Hudson (Contact)
Tuesday, June 17, 2008
The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found.
In one such experiment involving the controversial anti-smoking drug Chantix, the Department of Veterans Affairs (VA) took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police.
ROD LAMKEY JR./THE WASHINGTON TIMES Veteran James Elliott arrives at the Veterans Affairs Medical Center in Washington for his scheduled substance-abuse class in April. Mr. Elliott, a chain smoker, served 15 months in Iraq as an Army sharpshooter and suffers post-traumatic stress disorder.
ROD LAMKEY JR./THE WASHINGTON TIMES Iraq war veteran James Elliott opted for a government clinical trial for a smoking-cessation drug for $30 a month, starting in November. Two weeks later, the FDA informed the VA of serious side effects.
ROD LAMKEY JR./THE WASHINGTON TIMES STILL SMOKING: Iraq war veteran James Elliott smokes on his porch in Silver Spring as he talks about his experiences in war and dealing with post-traumatic stress disorder. Mr. Elliott suffered a psychotic episode while taking the anti-smoking drug Chantix.
James Elliott, a decorated Army sharpshooter who suffers from post-traumatic stress disorder (PTSD) after serving 15 months in Iraq, was confused and psychotic when he was Tasered by police in February as he reached for a concealed handgun when officers responded to a 911 call at his Maryland home.
Mr. Elliott, a chain smoker, began taking Chantix last fall as part of a VA experiment that specifically targeted veterans with PTSD, opting to collect $30 a month for enrolling in the clinical trial because he needed cash as he returned to school. He soon began suffering hallucinations and suicidal thoughts, unaware that the new drug he was taking could have caused them.
Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February.
In failing to do so, Mr. Elliott said, the VA treated him like a "disposable hero."
"You're a lab rat for $30 a month," Mr. Elliott said.
go here for more
http://washingtontimes.com/news/2008/jun/17/va-testing-drugs-on-war-veterans/
Experiments raise ethical questions
Audrey Hudson (Contact)
Tuesday, June 17, 2008
The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found.
In one such experiment involving the controversial anti-smoking drug Chantix, the Department of Veterans Affairs (VA) took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police.
ROD LAMKEY JR./THE WASHINGTON TIMES Veteran James Elliott arrives at the Veterans Affairs Medical Center in Washington for his scheduled substance-abuse class in April. Mr. Elliott, a chain smoker, served 15 months in Iraq as an Army sharpshooter and suffers post-traumatic stress disorder.
ROD LAMKEY JR./THE WASHINGTON TIMES Iraq war veteran James Elliott opted for a government clinical trial for a smoking-cessation drug for $30 a month, starting in November. Two weeks later, the FDA informed the VA of serious side effects.
ROD LAMKEY JR./THE WASHINGTON TIMES STILL SMOKING: Iraq war veteran James Elliott smokes on his porch in Silver Spring as he talks about his experiences in war and dealing with post-traumatic stress disorder. Mr. Elliott suffered a psychotic episode while taking the anti-smoking drug Chantix.
James Elliott, a decorated Army sharpshooter who suffers from post-traumatic stress disorder (PTSD) after serving 15 months in Iraq, was confused and psychotic when he was Tasered by police in February as he reached for a concealed handgun when officers responded to a 911 call at his Maryland home.
Mr. Elliott, a chain smoker, began taking Chantix last fall as part of a VA experiment that specifically targeted veterans with PTSD, opting to collect $30 a month for enrolling in the clinical trial because he needed cash as he returned to school. He soon began suffering hallucinations and suicidal thoughts, unaware that the new drug he was taking could have caused them.
Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February.
In failing to do so, Mr. Elliott said, the VA treated him like a "disposable hero."
"You're a lab rat for $30 a month," Mr. Elliott said.
go here for more
http://washingtontimes.com/news/2008/jun/17/va-testing-drugs-on-war-veterans/
Thursday, March 27, 2008
FDA Investigates Suicide With Merck Drug Singulair
FDA Investigates Suicide With Merck Drug
By MATTHEW PERRONE | AP Business Writer
4:29 PM EDT, March 27, 2008
WASHINGTON - The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received since last October.
It could take up to nine months before agency scientists can draw any conclusions, FDA said in a posting to its Web site.
click post title for the rest
By MATTHEW PERRONE | AP Business Writer
4:29 PM EDT, March 27, 2008
WASHINGTON - The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received since last October.
It could take up to nine months before agency scientists can draw any conclusions, FDA said in a posting to its Web site.
click post title for the rest
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