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VitaBeat (Free subscription) | 07/03/2009
The results of talks between Health Canada and Pfizer Inc. will determine the course of action Ottawa will make if it will place safety warnings on packaging of anti-smoking drugs known to have psychiatric side effects such as suicidal thoughts. Health Canada spokesperson Philippe Laroche said the agency expects an agreement with Pfizer may be signed by end of summer or fall.
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Another Pundit (Free subscription) | 07/03/2009
Newsmax.com - Suicide Warning Ordered on Anti-Smoking Drugs By: Susan Heavey U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts. The warnings, which must be added to Pfizer's Chantix and Glaxo's Zyban, follow more than...
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Medical News Today (Free subscription) | 07/02/2009
Pfizer Inc announced that it has updated the U.S. product labeling for CHANTIX® (varenicline), a prescription aid to smoking cessation treatment, to communicate important safety information in a boxed warning as well as in revised warnings and precautions. These updates are based on post-marketing reports and are being made in agreement with the U.S. Food and Drug Administration (FDA).
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Health - The Post Chronicle (Free subscription) | 07/02/2009
U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems....
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Medical News Today (Free subscription) | 07/02/2009
Pfizer Inc announced the discontinuation of the SUN 1122 Phase 3 trial that evaluated Sutent® (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC).
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Reuters UK (Free subscription) | 07/02/2009
WASHINGTON (Reuters) - U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts.
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Boston Globe (Free subscription) | 07/02/2009
U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts.
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Market Wire (Free subscription) | 07/02/2009
BIRMINGHAM, AL (MARKET WIRE) The FDA has mandated a "Black Box Warning" requiring Pfizer Inc., manufacturer of Chantix(R), to strengthen warnings about the health risks and dangers associated with using the drug. Chantix(R) (varenicline) is advertised as an aid to help people quit smoking. The order for a Boxed Warning comes on the heels of reports linking Chantix(R) to serious injuries and...
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Business Wire (Free subscription) | 07/01/2009
NEW YORK--(BUSINESS WIRE)--Graceway Pharmaceuticals, LLC, a portfolio company of GTCR Golder Rauner, LLC, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Acquisition and License Agreement by
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The Huffington Post (Free subscription) | 07/01/2009
NEW YORK — The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts. The new requirement, called a "Black Box" warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts...
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Market Watch (Free subscription) | 07/01/2009
BOSTON (MarketWatch) -- The Food and Drug Administration said Wednesday that it wants harsher warning labels on the smoking-cessation products Zyban and Chantix, advising that they can trigger serious mood swings, hostile behavior and suicidal thoughts in some users. Zyban is marketed by GlaxoSmithKline PLC while Chantix is sold by Pfizer Inc. The agency is requiring that the products now carry "boxed"...
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euronews24 (Free subscription) | 07/01/2009
NEW YORK - The Food and Drug Administration will require Pfizer Inc.'s smoking cessation drug Chantix to carry the agency's strongest safety warning over a series of mental health side effects, including depression and suicidal thoughts. The new req ...
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Times of the Internet (Free subscription) | 07/01/2009
WASHINGTON, July 1 (UPI) -- The U.S. Food and Drug Administration announced Wednesday it will require a boxed warning for the smoking cessation drugs Chantix and Zyban. The FDA said the boxed warning -- the strongest warning the agency can require -- will appear on the package insert. It will highlight the risk of serious mental health events, including changes in behavior, depressed mood, hostility...
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Detroit Free Press (Free subscription) | 07/01/2009
NEW YORK — The Food and Drug Administration will require Pfizer Inc.'s smoking cessation drug Chantix to carry the agency's strongest safety warning over a series of mental health side effects, including depression and suicidal thoughts.
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Miami Herald (Free subscription) | 07/01/2009
The Food and Drug Administration will require Pfizer Inc.'s smoking cessation drug Chantix to carry the agency's strongest safety warning over a series of mental health side effects, including depression and suicidal thoughts.
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