News Tagged ‘Food and Drug Administration

FDA favors Chantix over e-cigarettes. Why?

electronic smoke 2Chantix made an appearance in last week’s issue of the Journal of the American Medical Association (JAMA) when one contributor wrote that the Food and Drug Administration has acknowledged receiving nearly 100 reports of and nearly 200 reports of attempted likely linked to the use of Chantix. Additionally, the also said it is compliling reports of Chantix patients being involved in traffic accidents.

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Are e-cigarettes too good to be true?

electronic smokeI have that “born late” feeling. I quit smoking before I had a chance to “smoke” electronic cigarettes, the latest and most overtly sci-fi smoking cessation tool to come along in my lifetime. My first attempt to quit smoking was in 1989, 4 years after I started smoking, when my college roommate yanked a brand-new pack of smokes out of my hand and chucked them to the middle of a retaining pond near our New Mexico State dorm. I had given Keith my permission to do that or something like it “if you ever catch me with a pack of cigarettes again,” which was about seven hours earlier that same day.

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FDA now requiring stronger warnings on Chantix labels

chantix and smoking 100x100The U.S. Food and Drug Administration announced today that it will require drug manufacturers to put boxed warnings on the product labeling for Chantix (varenicline) and Zyban (bupropion hydrochloride, otherwise called Wellbutrin when prescribed as an antidepressant). Both Chantix and Zyban, commonly prescribed to patients as smoking cessation aids, have been linked to serious behavioral changes and other symptoms. Agitation, hostility, depression, and suicidal thoughts and actions are possible that users should be keenly aware of, the warns.

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Note to Chantix flunkees: there’s still hope even after the magic pill fails

smokes 100x100“It’s my mind-set this time,” Eric Wolbert told the St. Louis Post-Dispatch. “This time I’m going into it celebrating that I’m quitting rather than worrying about not being able to and how hard it was.”

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FDA monitoring Chantix for serious risks, new safety concerns

no smoking 100x100Last week, the Food and Drug Administration released a list of about 20 pharmaceutical drugs that the agency’s researchers are closely monitoring for potential safety concerns. Not surprisingly, Chantix (Varenicline) claimed a spot on the list. According to the , the drug is being watched to determine whether it causes or contributes to angiodema (rapid and potentially life-threatening swelling of skin and tissue), other serious skin reactions, visual impairment, and accidental injury.

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Pfizer and other drug companies fund medical courses

med school 100x100The Milwaukee Journal Sentinel recently published a comprehensive report that exposes a very questionable relationship between the University of Wisconsin-Madison college of medicine and the drug industry. Using the University of Wisconsin-Madison as an example, the report describes how pharmaceutical companies have infiltrated the nation’s universities by funding physician education courses. Critics argue that the arrangement is unethical; when a college accepts hundreds of thousands or even millions of dollars in funds for such classes, the patrons expect something back. So what might appear superficially as a philanthropic gesture is actually an arrangement with lots of strings attached — an arrangement, critics say, that amounts to huge conflicts of interest.

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More Canadians harmed by Chantix as government revises warnings

canada 100x100Health Canada has received 818 reports of adverse caused by the smoking cessation drug Chantix (marketed in Canada and elsewhere as Champix) since it first became available to Canadians nearly two years ago. The majority of complaints concerned psychiatric problems. Chantix is known to cause or exacerbate a spectrum of psychiatric and physical reactions, including moodiness, depression, violent behavior, lack of sleep, blackouts, and suicidal thought and actions.

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FDA scientists say their agency is corrupt and broken

fda logo 100x100A group of scientists at the Food and Drug Administration has sent a letter to President-elect Obama and his transition team, urging a clean-up of the government agency. The letter says that widespread mismanagement and incompetence in the agency have “placed the American public at risk.”

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Canada strengthens Chantix warnings

The Canadian Press reports that Health Canada, the government department responsible for Canada’s public health policies, is currently working with Pfizer to strengthen the warnings for the smoking cessation drug Chantix. Chantix is sold in Canada and elsewhere overseas under the name Champix.

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Are Chantix reactions a laughing matter?

The number of bloggers out there writing about their personal experiences with Chantix and documenting, for the world to see, the musings of a mind tortured by nicotine withdrawal, seems to be proliferating even as prescriptions for the smoking cessation drug decline. Now it appears that a new genre in world of Chantix information has emerged: the Comical Side Effect.

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