Quit Smoking Aids Articles





NICOTINE REPLACEMENT SAFE DURING PREGNANCY

Source: Reuters
Date: October 24, 2008

For women trying to quit smoking during pregnancy, using nicotine replacement therapy such as nicotine patches or nicotine gum does not increase the likelihood of a stillbirth, a study shows.

"Smoking during pregnancy increases the risk of stillbirth," the researchers write in the British Journal of Obstetrics and Gynecology. "The use of NRT (nicotine replacement therapy) in pregnancy is a possible harm reduction strategy," they add.

Using national data, Dr. K. Strandberg-Larsen, at the University of Southern Denmark in Copenhagen, and colleagues gathered information on NRT use and smoking for 87,032 singleton pregnancies.

Two percent of women reported using nicotine replacement during pregnancy. Of these women, 14 percent had not smoked during pregnancy, 30 percent had quit smoking during pregnancy, and 56 percent continued to smoke. Some quit smoking aids safe during pregnancy full article.

FDA MAY REVISE WARNING FOR ANTISMOKING DRUG

Source: The Wall Street Journal Interactive Edition
Date: October 23, 2008
Author: ALICIA MUNDY

The Food and Drug Administration said it may upgrade warnings on the Pfizer Inc. antismoking drug Chantix after a nonprofit safety group cited a new spate of road-traffic accidents and seizures involving people on the drug.

The Institute for Safe Medication Practices said 1,001 serious incidents involving Chantix users were reported in the first quarter of this year, based on its analysis of government safety data. That is more than the total number of serious incidents for the top 10 most-prescribed brand-name drugs combined.

The institute, based in Horsham, Pa., said 15 cases in the quarter were connected to traffic accidents and 52 cases were linked to blackouts.

An FDA statement said the agency "confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline [Chantix] in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate."

Pfizer, which has been struggling to overcome nearly a year of negative publicity involving Chantix, questioned the report's conclusions. Warning Label for Chantix full article.

NEW INVESTIGATIONAL "LIQUID CIGARETTE" SMOKE CESSATION PRODUCT ACHIEVES 71 PERCENT QUIT RATE

Source: PR Web
Date: September 26, 2008

Several months ago, 52 smokers embarked on an FDA-approved, 12-week clinical study of a new smoke-cessation device called Smoke-Break. The results of the study were released today with 71 percent of the study participants smoke-free after 12 weeks.

Smoke-Break is a "liquid nicotine cigarette" that resembles an unlit cigarette in size and shape. The clear tube contains a cherry-flavored gel along with 1.5 milligrams of nicotine, about as much as in a light cigarette. Users consume the liquid by lifting the tube to their mouths, and sipping through a mouthpiece, much like they would draw on a cigarette.

Approved by the FDA for clinical study in 2007, the study sought to determine whether Smoke-Break would help smokers stop smoking, while avoiding the side effects seen in other smoke-cessation products. The answer is yes, and that's promising news to study sponsor Dr. Carl E. Olson, Chairman of the Radiation Oncology Department at Columbia St. Mary's in Milwaukee. New quit smoking aid clinical trial full article.

NICOTINE NASAL SPRAY A NO-GO FOR TEEN SMOKERS

Source: Reuters
Date: September 10, 2008
Author: Anne Harding

Nicotine nasal spray won't help teen smokers kick the habit, at least in its current formulation, new research published in Pediatrics suggests.

Adolescents who tried the spray complained of burning in their nostrils, a bad smell, and other side effects, leading them it stop using it or using it too infrequently to be effective, Dr. Mark L. Rubenstein and his colleagues from the University of California, San Francisco found.

"It's actually one of the most effective forms of nicotine replacement in adults," Rubenstein noted in an interview with Reuters Health. "Usually the side effects are supposed to wear off during the first week."

The researchers had high hopes for success because the spray is very fast-acting and it allows the patient to control the dosage. Nicotine nasal spray and adolescents full article.

VACCINES AGAINST SMOKING, OBESITY AND HIGH BLOOD PRESSURE COULD BE DEVELOPED 'WITHIN THE NEXT DECADE'

Source: The Mail (uk)
Date: July 31, 2008
Author: Daily Mail Reporter

Vaccines against smoking, obesity and high blood pressure could all be developed within the next decade, scientists believe.

Anti-smoking vaccines are also undergoing human trials, this week's New Scientist magazine reports. In a U.S. trial of 300 cigarette smokers, 15 per cent of those vaccinated quit after a year of treatment.

RNew Scientist says: 'The second vaccine revolution will not eradicate killer diseases.

'It might, however, cut the death toll from problems, that, if untreated, will become some of the biggest killers of the 21st century.' Smoking Vaccine full article.

HEAD-TO-HEAD STUDY RESULTS DEMONSTRATED NO SIGNIFICANT DIFFERENCE BETWEEN NICODERM(R) CQ(R) AND CHANTIX (VARENICLINE TARTRATE) IN LONG TERM QUIT RATES

Source: PR Newswire
Date: July 28, 2008
Author: SOURCE GlaxoSmithKline

New data published today in the August issue of Thorax shows no significant differences in 6-month and 1-year quit rates between the NicoDerm(R) CQ(R) Clear Patch and Chantix (varenicline tartrate) despite statistically higher quit rates for Chantix (varenicline tartrate) at 12 weeks. According to the official 2008 U.S. Public Health Service Guideline, longer-term quit rates at the 6-month milestone are the most predictive of long-term success.

The Thorax paper, entitled, "Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial", reports on a 52-week study that is the first-ever direct comparison of the NicoDerm CQ Clear Patch to Chantix (varenicline tartrate). The study was conducted using an "open-label" design, meaning that subjects knew what medication they were taking. Though this design may have favored the new pill, Chantix (varenicline tartrate) did not demonstrate long-term superiority to NicoDerm CQ.

"This study confirms that there is no magic bullet when it comes to smoking cessation and that both therapeutic nicotine and Chantix (varenicline tartrate) demonstrate long-term effectiveness," Quit smoking patch and Chantix full article.

SMOKING CESSATION THERAPIES MORE EFFECTIVE THAN PLACEBOS

Source: EurekAlert
Date: July 14, 2008

Six treatments for smoking cessation perform better than placebos — including varenicline (Chantix®), recently approved for use in Canada — states a team of researchers from McGill University and the University of Montreal in an article published in CMAJ.

This meta-analysis of placebo-controlled randomized controlled trials totaling 32,000 participants found that varenicline, nicotine nasal spray, bupropion (Wellbutrin®), nicotine patches, tablets and gum helped people quit smoking. However, "despite the documented efficacy of these agents, the absolute number of patients who were abstinent from smoking at 12 months was low."

According to the authors, varenicline was about twice as effective as bupropion. Quit smoking aids full article.

THE FUTURE OF NICOTINE ADDICTION TREATMENT -- A NICOTINE VACCINE?

Source: EurekAlert
Date: June 12, 2008URL:

Nicotine addiction is a chronic illness, and reducing the massive burden of death and disease associated with it will require matching individual treatments to patients, along with the necessary public health messages, concludes a Seminar in this week's edition of The Lancet. Future treatments in development include an antinicotine vaccine. And an accompanying Comment looks at the importance of a broad range of anti-tobacco strategies, and focuses on the importance of the implementation of The Framework for Tobacco Control.

In the Seminar, by Dr Dorothy Hatsukami, Tobacco Use Research Center, University of Minnesota, MN, USA and colleagues look at the startling death rates associated with smoking. There are around 1.2 billion smokers worldwide, more than half of whom will die from diseases caused by smoking. Roughly 5 million smokers die per year at present, though this could be 10 million per year by 2025 if present trends continue. . . .

The authors conclude: "Nicotine or tobacco addiction should be treated as a chronic disorder. Treatment can need persistent efforts to try to assist tobacco users in their attempts at quitting. Relapse should be seen as a probable event ...Treatment can improve these outcomes....The most crucial component of care is the actual delivery of such treatments."

In the accompanying Comment, Dr Kenneth Warner. School of Public Health, Ann Arbor, MI, USA, and Dr Judith Longstaff Mackay, Bloomberg Initiative to Reduce Tobacco Use, Hong Kong, China, discuss the importance of implementing The Framework Convention on Tobacco Control (FCTC), currently ratified by 154 countries.

They conclude that the medical community needs to make treatment of tobacco dependence a high priority in everyday practice, and also to lobby governments - which are often conflicted by their own financial dependence on tobacco - to implement FCTC. They conclude: "Here is something simple, achievable, and unequivocally good that would relieve the suffering of literally millions of human beings." Quit smoking vaccine full article.

HEALTH BLOG : PFIZER CLEARS AIR AT CHANTIX ROUNDTABLE

Source: Wall Street Journal Blogs
Date: June 5, 2008
Author: Posted By Avery Johnson, healthblog@wsj.com

Pfizer invited a bunch of folks, including the Health Blog, to a media roundtable about Chantix at the company's 42nd Street HQ this morning.

Chantix, if you're just tuning in, has weathered a lot of safety questions recently. The label for the drug has been beefed-up to warn about suicidal thinking, and a recent report linked the medicine to a range of possible side effects from seizures to accidents.

By way of introduction at today's meeting, Pfizer's VP for media relations Ray Kerins explained to the group that Pfizer wanted to openly correct misunderstandings and misinterpretations in the marketplace.

Here's a summary of Pfizer's main points:

  • #1 Smoking is a serious health problem that kills people.
  • #2 Most of the adverse events that have been reported recently are already in the Chantix label.
  • #3 Smokers who are trying to quit can be depressed and irritable.
  • #4 Paying close attention to adverse-event reports helps the FDA and Pfizer enhance drug safety.

On that last point, Pfizer cautions that real-world, post-market reports aren't the gold standard of clinical research and shouldn't be interpreted as such. Chantix full article.

NICOTINE REPLACEMENT THERAPY IS SAFE, EFFECTIVE AND CAN HELP REVERSE MENTAL ACUITY DEFICITS IN SMOKERS WHO ARE QUITTING, INCLUDING COMMERCIAL AND PRIVATE PILOTS
Source: PR Newswire
Date: May 22, 2008
Author: SOURCE GlaxoSmithKline Consumer Healthcare, sschwarz@golinharris.com

In light of today's announcement by the Federal Aviation Administration (FAA) that it has removed a prescription anti-smoking pill from their approved list of safe medications for pilots and air-traffic controllers, it's important to note this news does not include nicotine replacement therapy (NRT) which is deemed safe and effective. (1) Further, recent research has found the Commit 4 mg lozenge has been clinically proven to help reverse nicotine withdrawal symptoms associated with quitting smoking including the following: difficulty concentrating, attention deficit, short-term memory deficit and selective attention deficit (2) -- some of the issues at the core of today's report.

In 1994, the FAA requested the Centers for Disease Control(CDC) assemble an expert panel to examine the effects of smoking and tobacco addiction and withdrawal on pilot performance and airline safety. As part of the panel's conclusion, they found NRT to be safe, effective treatment option for pilots who smoke. Those recommendations stand to this day.

"Nicotine withdrawal is a serious issue for pilots who are in the process of quitting smoking, and today's news could have a dramatic impact on these individuals," said Jack E. Henningfield. Nicotine replacement therapy full article.

STRONG SIGNAL SEEN ON NEW VARENICLINE RISKS
Source: Institute for Safe Medication Practices
Date: May 22, 2008

A strong signal of multiple safety problems with Chantix (varenicline), a drug to help people stop smoking, has been seen in a pilot program to identify new drug risks in adverse drug events reported to the U.S. Food and Drug Administration. . .

Recommendations - We have immediate safety concerns about the use of varenicline among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury. Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices. Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings. The extent to which varenicline has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported. The Federal Aviation Administration approved varenicline for use by airline pilots before most of these reports were available.

In addition, we recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.

Finally, we urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks. We promptly notified the FDA of our findings...

Conclusions - We emphasize the recommendations outlined in the executive summary. We have concern about the use of varenicline by persons in settings where the risk of accident is high; we recommend doctors and patients exercise caution in the use of varenicline and consider alternative methods of smoking cessation. The FDA and the manufacturer should on a priority basis assess the information available and conduct additional research where current data are insufficient to resolve questions about the safety of varenicline.

Full article no longer available.

FAA BANS ANTI-SMOKING DRUG CHANTIX
Source: USA Today
Date: May 21, 2008
Author: Rita Rubin, USA TODAY

The Federal Aviation Administration on Wednesday removed the smoking cessation drug Chantix from the list of medications considered safe for pilots and air-traffic controllers after a new study linked the medication to mental confusion and other problems that could put passengers at risk.

FAA spokesman Les Dorr said the agency took that step after reviewing the study, which raises concerns about Chantix use by people operating vehicles.

The study links the drug to loss of consciousness, lapses in alertness, dizziness and muscle spasms. Dorr said the FAA has not heard of crashes linked to Chantix. The FAA will send letters about the change to the Aircraft Owners and Pilots Association, pilots' unions and people "we know are taking" the drug. . .

The study was posted online by the non-profit Institute for Safe Medication Practices. Co-author Curt Furberg, a Wake Forest University medical epidemiologist, said he and his coauthors felt "this was too important" to submit first to a medical journal, which could take six months or more to publish.

Since Chantix's approval in May 2006, Furberg said, 5 million people have taken the drug worldwide, 3.5 million in the USA. FAA and Chantix full article.

NICOTINE CONJUGATE VACCINE MAY HELP SMOKERS QUIT SMOKING AND REMAINABSTINENT
Source: Medscape
Date: May 20, 2008
Author: Laurie Barclay, MD

A nicotine conjugate vaccine (NicVAX, Nabi Biopharmaceuticals) might help smokers quit smoking and remain abstinent, according to a presentation of animal and human data at the Eleventh Annual Conference on Vaccine Research, held in Baltimore, Maryland, from May 5 to 7.

"The human study was designed to demonstrate proof of the concept that antibodies to nicotine are useful in helping smokers quit," lead author and presenter A.I. Fattom, PhD, vice-president of research and development at NabiBiopharmaceuticals, in Rockville, Maryland, told Medscape Infectious Diseases. "Animal data indicated that antibodies to nicotine reduced the amount and slowed the entry of nicotine into the brain, and demonstrated that treated animals showed reduced physiologic and behavioral responses to nicotine after vaccination. These observations were tested in a series of clinical studies...designed to show that NicVAX could produce antibodies in humans and to identify the best dose and dosing regimen."

Full article no longer available.

Doctors: Chantix Benefits Outweigh Risks
Source: Fox News
Date: May 9, 2008
Author: Marrecca Fiore

The drug Chantix may be linked to suicidal thoughts and depression in some people, but the risk of smoking is far worse, according to some physicians.

The health risks of smoking, including lung cancer, emphysema, stroke and heart attack, outweigh the known side effects of Chantix, said Dr. Marc Siegal, a FOX News Channel contributor.

"I still think it's a first-line agent," Siegal, a board certified internist and clinical associate professor of medicine at New York University School of Medicine, told FOXNews.com. "It's absolutely the best thing we have out there to help people stop smoking."


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