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• Smoking--Medicines To Help You 

You are a woman. You are a smoker.

You are not alone. Approximately 18% of adult women smoke. More than half of all smokers want to quit. There is help.

Read this guide … even if you are not ready to quit now. Learn more about products and medicines to help you quit smoking. Read tips to help you make a quit smoking plan that may work for you. Use this guide to help you talk to your pharmacist or doctor.

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FDA: Anti-smoking drugs can make you crazy 

Trying to quit smoking and feel like running into traffic, killing yourself or offing your partner, boss or children? It may be that drug you're taking to help you kick the habit.

The Food and Drug Administration on Wednesday announced it has ordered the makers of the prescription anti-smoking medications Zyban and Chantix (also known by their pharmaceutical names bupropion and varenicline) to warn patients that taking the drugs may cause changes in behavior and mood, including hostility, agitation, depression and suicidal thoughts or behavior. The new warnings will be included in a "black box" intended to alert consumers to important side effects of a drug. . . .

Both medications were approved by the FDA after their manufacturers presented evidence that taking these drugs increased a smoker's likelihood of successfully quitting the habit. But there are many other ways to stop smoking, all of them laid out here (or call [800] QUIT-NOW). Thinking about quitting cold turkey -- no pills, gums, patches or excuses? Here's a site for you too.

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Anti-Smoking Drugs Get FDA 'Black-Box' Warning  

Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, U.S. health officials said Wednesday.

The U.S. Food and Drug Administration said it was mandating the black-box warnings, the strictest possible, based on reports to the agency of these side effects and on a review of clinical trials and scientific literature.

"We are requiring the manufacturers of the smoking-cessation drugs Chantix and Zyban to add a new boxed warning highlighting the risk of serious mental health symptoms with use of these products," Dr. Curt Rosebraugh, director of the FDA's Office of Drug Evaluation II, said during a Wednesday teleconference.

The agency's review found that some people who used Chantix (varenicline) and Zyban (bupropion) experienced unusual changes in behavior, became depressed, or had their depression worsen and had thoughts of suicide or dying, the FDA said.

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Popular Stop-Smoking Drugs to Carry Mental Health Risk Warnings 

Reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA's adverse event reporting system.

Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in buproprion users, the agency reported.

The FDA is not recommending discontinuation of the medications, which have been shown effective for quitting smoking, according to Dr. Curtis Rosebraugh, director of the agency's Office of Drug Evaluation II.

But the FDA is recommending that clinicians monitor their patients for neuropsychiatric symptoms after initiating treatment.

The FDA has been conducting a safety review of varenicline since receiving preliminary reports of problems in 2007.

Rosebraugh said it was somewhat surprising that a similar safety signal turned up for buproprion.

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Pfizer, Glaxo Smoking Pills Get Warning on Suicides (Update2) 

Pfizer Inc. and GlaxoSmithKline Plc’s quit-smoking treatments must carry the strictest U.S. warning about psychiatric side effects, including the risk of suicide.

The Food and Drug Administration is adding the warnings, which will be highlighted in a black box, to the prescribing information of Pfizer’s Chantix and Glaxo’s Zyban. The agency has received a combined 317 reports of suicides and attempted suicides among patients taking the drugs, said Curtis Rosebraugh, director of the FDA’s Office of Drug Evaluation II, in a conference call today with reporters.

Pfizer said it stands by the safety of Chantix and Glaxo said it doesn’t believe there is enough evidence to prove a link. The FDA warned in January that Chantix may increase the risk of suicide or erratic behavior, and the Federal Aviation Administration banned its use in pilots. Chantix sales plunged 36 percent to $177 million in the first quarter, Pfizer said.

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Suicide Warnings Required for Anti-Smoking Drugs  

The Food and Drug Administration announced today that it is requiring the smoking-cessation drugs Chantix and Zyban to carry the strongest type of safety warning possible to alert patients that the medications can cause serious mental health problems, including depression and suicide.

The agency said it took the action requiring "boxed warnings" after finding a surprisingly high number of reports of problems involving changes in behavior among people taking the medications, including depression, hostility, suicidal thoughts and attempted and successful suicides. The agency had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban, officials said.

Agency officials said they were unsure why the drugs would cause these problems and noted that many of the symptoms can occur from nicotine withdrawal as well. The agency is requiring the companies that make the drugs to conduct follow-up studies to try to explore how commonly mental health problems occur. . . .

The FDA stressed that it was not advising people against using the medications because smoking causes serious health problems and quitting smoking is important. But patients taking the drugs and their doctors need to be aware of the potential problems and monitored closely, officials said.

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• FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban  

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

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FDA Warning on Stop-Smoking Drugs 

The FDA warns that bizarre behavior -- including suicide -- is seen in people taking the stop-smoking drugs Chantix and Zyban.

Both drugs now will carry "black box" labels warning that people taking the drugs should be closely watched for signs of suicidal thoughts, depression, hostility, or other changes in behavior.

"We want people to use these drugs carefully and pay attention," Robert J. Temple, MD, director of the FDA's office of medical policy, said at a news conference. "Stopping smoking is a goal we all want to work toward. We don't want to scare people off these drugs -- we just want them carefully monitored."

It's not at all clear that the drugs actually cause these behavior changes. Smokers are addicted to nicotine -- and when they quit, their withdrawal symptoms can include many bizarre behaviors, including suicide.

However, Curt Rosebraugh, MD, MPH, director of one of the FDA's drug evaluation units, said that some of the suicide reports came from Chantix users who were still smoking.

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• F.D.A. Warnings on Stop-Smoking Drugs Chantix and Zyban  

ederal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs' users.

But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.

"Stopping smoking is a goal we should all be working towards," said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. "We don't want to scare people off from trying a medication that could help them achieve this goal. You should just be careful."

Pfizer will add a so-called black box warning -- the F.D.A.'s most serious caution -- to the packaging information for Chantix.

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Man who drove front-end loader into Forks Township home blames smoking-cessation drug Chantix 

A Forks Township man blamed the smoking-cessation drug Chantix for leading him to smash a Bobcat front-end loader into his patio.

Charles L. Brinker, of the 1000 block of Frost Hollow Road, said he was quitting smoking and taking the drug, which has side effects ranging from nausea to suicidal thoughts and depression.

"I believe that had a lot to do with it ... I'm not a doctor or anything," Brinker said today in Northampton County Court.

Brinker threatened to tear down his home while his wife, Diane Brinker, and three others were inside, according to court papers.

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• Pill to make smokers forget their craving 

A blood pressure pill might help people quit smoking.

Researchers believe that the beta blocker drug works on certain brain chemicals and effectively deletes some of the memories associated with the habit.

New wonder pill 'blocks or erases memory from smoking'

It is these memories which help drive the craving and lead to thousands of would-be quitters relapsing. . . .

The new treatment, known as memory reconsolidation blockade, targets this craving and could be used in conjunction with nicotine replacement therapy.

Smoking, along with many drug addictions, triggers an increased release of the brain chemical dopamine, a neurotransmitter that is involved in controlling movement, emotional response, the ability to experience pleasure and pain, and short-term memory. . . .

Previous studies on animals have shown that those given injections of a beta blocker were less likely to recall being afraid of certain things.

In the trial at Massachusetts General Hospital, smokers who have smoked at least ten cigarettes a day for the past three months are being given the beta blocker propranolol.

The study, which involves 50 smokers, includes a smoking cessation phase, where the men and women will be given nicotine patches, and a relapse prevention phase where they will be assigned to receive either propranolol or a placebo once a week for six weeks.

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Quit-smoking pill sparks health warning 

Health authorities have issued a new warning on the mental health risks of a quit-smoking pill introduced to New Zealand in 2007.

More than 3300 people were prescribed Champix, which contains the chemical varenicline, in the first year of its use in New Zealand.

There were 22 reports of people experiencing depression for the first time after taking Champix. Recurrence or worsening of existing depression, and other psychiatric and neurological symptoms, were also reported.

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I QUIT! 

It's like a voice in the back of my head insisting that I get a smoke and if I don't, the voice just nags until I give in," Semper shared.

Semper is not alone. In fact, according to Parliamentary Secretary in the Ministry of Health Senator Wesley George, there are over 200,000 smokers in Trinidad and Tobago. George shared the figures during his speech on the Tobacco Control Bill at the Association of Psychiatrists of Trinidad and Tobago's recent symposium at the Kapok Hotel, the theme of which was "The Social ills of Cigarette Smoking".

Statistics provided at the symposium showed that of the 1.22 billion smokers worldwide, 1 billion of these are in developing countries. Smoking is on the decline in developed countries such as the US but on the increase in the developing countries. Trinidad and Tobago has the fourth highest rate of smokers amongst secondary school children between the ages of 13 and 15 years. . . .

But the new weapon in the fight against smoking is the drug Champix (Varenicline). This has promising results and compared to Zyban, 44 per cent of smokers quit by the end of 3 months as compared to 30 per cent with Zyban.

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GABLER: Pfizer's sneaky ad promotes anti-smoking drug  

By law, a pharmaceutical company cannot mention a drug's name without listing its most serious side effects. Pfizer has thought up a creative way around this law. But first you should know this: Chantix has some significant side effects: "serious neuropsychiatric symptoms," including "changes in behavior, agitation, depressed mood, suicidal ideation and attempted and completed suicide," according to the FDA.

Pfizer has found a way to promote its drug without mentioning the side effects. The company has been running an ad promoting a smoking-cessation site called MyTimeToQuit.com. It's sponsored by Pfizer. Once on the site, consumers will find links to the Web site for Chantix.

Public Investigator wrote about the possible dangers of Chantix last April. In that story, we spoke with a Green Bay man and his wife who said they were not aware of the drug's side effects. Here's what happened to that couple, or click here for the full article:

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• Drug firms' cash skews doctor classes 

Drug companies have largely taken over the field of doctor education, in part by bankrolling physician education courses at medical schools.

Critics say the practice increases medical costs by encouraging doctors to write prescriptions for expensive brand-name drugs and by exaggerating the frequency and prevalence of rare conditions. It also promotes the use of drugs not approved for the ailments.

A Journal Sentinel investigation found that industry-funded doctor education courses offered at UW often present a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects. . . .

Smoking cessation course

Some of the biggest money paid to UW has been for its smoking cessation course, part of a national campaign funded by Pfizer.

Of the $12.3 million paid by the drug company to fund the course, $3.5 million is going to UW.

The course materials heavily promote Pfizer's drug, Chantix, considered to be the most effective drug on the market. But the drug is under investigation by the FDA, and in its relatively short history on the market, it has been linked to serious side effects, none of which is mentioned in the course.

Side effects include depression, agitation, suicidal behavior and blackouts. For two consecutive quarters, Chantix was connected with more serious injuries than any other prescription drug, according to an October report by the Institute for Safe Medication Practices. Since its approval in 2006, the drug has been linked to 3,325 serious injuries and 112 deaths in the U.S.

Last May, the FAA ordered pilots and air traffic controllers to immediately stop taking the drug because of safety concerns.

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