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"European regulators have removed the black triangle warning from the label of Pfizer's smoking cessation drug Champix, on the back of data from a post-marketing surveillance study backing its neuropsychiatric safety. - News - PharmaTimes", www.pharmatimes.com
"Europe's main drug regulator has lifted a seven-year-old warning about possible suicidal risks from Champix, Pfizer's smoking-cessation pill. The European Medicines Agency's ruling could boost sales of Champix, also known as Chantix, by reassuring doctors and would-be ex-smokers that the prescription medicine doesn't have dangerous psychiatric side effects. The EMA's decision, announced on Monday by New York-based Pfizer, comes after an 8144-patient, 16-country study found users had no elevated risk of suicides, suicide attempts or suicidal thoughts.", www.sbs.com.au
"The European Medicines Agency's ruling could boost sales of Champix, the drug's name in Europe, by reassuring doctors and would-be ex-smokers that the prescription medicine doesn't have dangerous psychiatric side effects. The EMA's decision, announced Monday by New York-based Pfizer Inc., comes after an 8,144-patient, 16-country study found users had no elevated risk of suicides, suicide attempts or suicidal thoughts. Many doctors and smokers trying to quit were scared off by warnings on Chantix and Zyban, about 'changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions' in some patients. In that group, suicidal thoughts or behavior or other serious mental health issues were reported in about 6.5 percent given Chantix or Zyban and 5 percent given the nicotine patch or dummy pills.", www.seattlepi.com
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