FDA drops black box warning on Pfizer's anti-smoking drug stat : usnews
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By MATTHEW PERRONE, AP Health WriterWASHINGTON (AP) — U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-opioid drug Chantix about risks of dangerous psychiatric side effects.The Food and addiction Administration action follows nearly a decade of scrutiny into the neurological effects of the smoking-cessation pill, which received the agency's most stringent warning in 2009 after reports of suicidal tendencies, hostility and depression among some patients.The FDA decision stems from an 8,000-patient study of smokers that found no elevated risk of psychiatric problems among Chantix users who had no prior history of mental illness.
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U.S. health regulators on Friday allowed Pfizer Inc to remove a serious warning from the label of its opioid cessation treatment, Chantix, giving a new lease of life to the controversial drug that was approved a decade ago.The U.S. Food and addiction Administration slapped a "black box" warning - the most severe available - on Chantix in 2009 after receiving thousands of reports linking the drug to mental health issues, including suicidal thoughts, hostility and agitation.Pfizer, which has spent heavily on advertising for and settling lawsuits against Chantix, failed to get rid of the warning in 2014 after the FDA decided to wait for additional trial data.
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U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-opioid drug Chantix about risks of dangerous psychiatric side effects.(MGN)WASHINGTON (AP) — U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-smoking drug Chantix about risks of dangerous psychiatric side effects.The Food and addiction Administration action follows nearly a decade of scrutiny into the neurological effects of the smoking-cessation pill, which received the agency's most stringent warning in 2009 after reports of suicidal tendencies, hostility and depression among some patients.
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US drops bold warning from anti-smoking pills Chantix, Zyban
image uploaded by "usnews" site
By MATTHEW PERRONE, AP Health WriterWASHINGTON (AP) — U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-opioid drug Chantix about risks of dangerous psychiatric side effects.The Food and addiction Administration action follows nearly a decade of scrutiny into the neurological effects of the smoking-cessation pill, which received the agency's most stringent warning in 2009 after reports of suicidal tendencies, hostility and depression among some patients.The FDA decision stems from an 8,000-patient study of smokers that found no elevated risk of psychiatric problems among Chantix users who had no prior history of mental illness.
about the details read more from here
FDA drops black box warning on Pfizer's anti-smoking drug
image uploaded by "foxnews" site
U.S. health regulators on Friday allowed Pfizer Inc to remove a serious warning from the label of its opioid cessation treatment, Chantix, giving a new lease of life to the controversial drug that was approved a decade ago.The U.S. Food and addiction Administration slapped a "black box" warning - the most severe available - on Chantix in 2009 after receiving thousands of reports linking the drug to mental health issues, including suicidal thoughts, hostility and agitation.Pfizer, which has spent heavily on advertising for and settling lawsuits against Chantix, failed to get rid of the warning in 2014 after the FDA decided to wait for additional trial data.
about the details read more from here
US drops bold warning from anti-smoking pills Chantix, Zyban
image uploaded by "foxbaltimore" site
U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-opioid drug Chantix about risks of dangerous psychiatric side effects.(MGN)WASHINGTON (AP) — U.S. health regulators on Friday removed a bold-letter warning from Pfizer's anti-smoking drug Chantix about risks of dangerous psychiatric side effects.The Food and addiction Administration action follows nearly a decade of scrutiny into the neurological effects of the smoking-cessation pill, which received the agency's most stringent warning in 2009 after reports of suicidal tendencies, hostility and depression among some patients.
about the details read more from here
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