News Tagged ‘FDA

Support group says Chantix ads conceal important information

snuffedWhyQuit, an organization that advocates quitting smoking using the cold turkey method, recently published an article that takes Pfizer to task over its latest Chantix ads. The group claims that the pharmaceutical company’s new television commercials hide information from the viewer – information that, if known, would likely dissuade most smokers from using the drug as a smoking cessation aid.

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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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Family of musician killed in Chantix rage sues Pfizer

chantix death 100x100The family of musician Carter Albrecht has filed a lawsuit in a Dallas federal court against Chantix manufacturer Pfizer Inc. Ken and Judy Albrecht allege that the drug manufacturer is responsible for the musician’s death in 2007 because it marketed Chantix, which Carter had been taking at the time of his death, while knowing it to be unsafe.

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FDA approves stronger, expanded warnings on Chantix labeling

smoky 100x100The Food and Drug Administration has approved the new labeling for Chantix packaging. In July, we reported that the agency said it would require stronger warnings on all Chantix labeling, as well as packaging for other smoking cessation drugs Wellbutrin and Zyban (bupropion hydrochloride). All of the drugs have been linked to serious behavioral changes and other symptoms.

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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 might fund study of Chantix and reduced risk of heart attack

butt 100x100CNN reports that Pfizer is thinking about launching a clinical test to determine if Chantix can help prevent smokers from having heart attacks. Considering all the negative publicity that has surrounded the drug over the last one and a half years, it’s understandable that Pfizer would want to invest a good deal of time and money in finding some benefit … even if they locate just one slightly dubious side effect, such as a reduced risk of heart attack in people who have quit smoking.

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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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