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Headlines Tagged with Vaccines 1,092 headlines found

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FDA panel recommends dropping serious warning on Pfizer's Chantix

A serious warning on Pfizer Inc's quit smoking drug should be removed, 10 of 19 independent panelists to the U.S. Food and Drug Administration recommended on Wednesday, after reviewing additional trial data on the controversial treatment.
Reuters
added Sep 15, 2016 22:11
7 Views

FDA Panel Splits on Softening Chantix Warning

10 voted to remove the warning, four voted to modify warning language to reflect results from a recently completed postmarketing trial and five wanted the warned to stay unchanged. FDA does not have to honor the committees' vote, and a vote this close is
MedPage Today
added Sep 15, 2016 18:12
6 Views

FDA Advisory Committees Recommend to Remove Boxed Warning in Labeling for Pfizer’s Smoking Cessation Therapy, CHANTIX® (varenicline)

reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) evaluating the neuropsychiatric safety of CHANTIX® (varenicline). The Committees recommended by a majority vote to remove the boxed warning regarding serious neurops
Business Wire
added Sep 15, 2016 17:52
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BRANNON / GOLDMAN: Up in Smoke / How an FDA drug warning harmed the fight against smoking.

In essence, the fear engendered by warnings of a bizarre but likely non-existent side-effect has led thousands of people to continue smoking, a substantial proportion of whom will assuredly become afflicted with emphysema, lung cancer, heart disease, or
Weekly Standard
added Sep 14, 2016 18:07
2 Views

BRANNON / GOLDMAN: Up in Smoke / How an FDA drug warning harmed the fight against smoking.

In essence, the fear engendered by warnings of a bizarre but likely non-existent side-effect has led thousands of people to continue smoking, a substantial proportion of whom will assuredly become afflicted with emphysema, lung cancer, heart disease, or
Weekly Standard
added Sep 14, 2016 18:07
8 Views

FDA Reviewers Question Chantix/Zyban Safety Study / Inclusion criteria and data collection criticized

"It seems reasonable to conclude that the exact incidence of neuropsychiatric adverse events of significance and perhaps scope of neuropsychiatric adverse events of significance was not accurately captured by the study," FDA reported in a memorandum date
MedPage Today
added Sep 14, 2016 14:12
5 Views

Trends in Use of Medications for Smoking Cessation in Medicare, 2007–2012

Use of smoking-cessation medications among Medicare beneficiaries remains low. Health effects of Medicare policies that increase coverage for medical support for smoking cessation may be limited by low utilization of effective medications.
American Journal of Preventive Medicine
added Sep 2, 2016 14:54
4 Views

[Europe] VIDEO: Varenicline underused for smoking cessation

“Unfounded” concerns about cardiovascular effects have contributed to underuse of varenicline for smoking cessation, Kornelia Kotseva, MD, said at the annual congress of the European Society of Cardiology. In an exclusive video interview, Dr. Kotseva of
Family Practice News
added Aug 31, 2016 13:43
9 Views

Varenicline for smoking cessation and reduction in people with severe mental illnesses: systematic review and meta-analysis

Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of ne
Wiley Online Library
added Aug 15, 2016 13:14
7 Views

‘The stop-smoking pill made me do it': Man found not criminally responsible for shooting wife

Pfizer, the maker of Chantix, has denied that the drug has any neuropsychiatric effects. But McClatchy News Service reported in 2014 that more than 2,000 people had joined in lawsuits against Pfizer for various psychiatric problems, including suicide and
Washington Post
added Aug 9, 2016 17:03
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