For many people, however, (including me), the Chantix experience isn’t one of wild extremes. It’s more like a strange trip through life with a brain that feels somehow different from the brain you had before. You feel normal and behave normally most of the time, but occasionally you find yourself saying or doing something that is not you, and the realization that accompanies this uncharacteristic behavior leaves you feeling disembodied and maybe even a little crazy.

New York magazine recently published an excellent article by a guy who recounts his own journey through a landscape made murky by Chantix. If you are one of the people who are seriously considering taking Chantix but trepidatiously wonder what it will be like for you, read Derek De Koff’s story, which echoes the experiences of so many people in blogland.

De Koff writes, “After a few weeks on Chantix, I had managed to stop smoking altogether—but it didn’t feel like a triumphant turn of events. I’d become rather reclusive, avoiding calls from friends, and basically just shuttling back and forth between my office and my apartment. I began to dread six o’clock; it meant I had to walk through the streets again. The subway was now out of the question; it made me too nervous. I stopped going to the gym, too.

“I wondered whether Chantix was zapping my brain’s pleasure-delivery system to such a degree that not only did I find no reward in cigarettes, but I also found no reward in socializing, exercising, writing, or any of my usual self-stimulating tricks. I’d pace the floor, sit on the bed, channel surf, pace some more, try to read, but the room had a stale, sinking feeling.”

So many people have such enormous expectations of Chantix, but the basic truth is that it may work for you (at least in the short term) and it may not work for you at all. If you decide to use it, monitor your behavior closely. I’m one of the people who took Chantix unsuccessfully. Ultimately it was the power to control my own thoughts that worked for me, bolstered by the fact that I had spent hundreds of dollars on a drug that did nothing but make me feel weird, half crazy, and “out of it” most of the time.

If Rep. Henry Waxman (D-Cal.) has his way, such ads will be a thing of the past, unless the advertised drug has proven to be safe over time. Waxman has renewed the push to give regulators the power to ban direct-to-consumer (DTC) advertising for new prescription drugs when their safety profiles aren’t fully known. The would-be legislation, which emerged in 2007 but ultimately failed to pass, is plowing ahead in the wake of some heavily promoted but beleaguered blockbuster drugs.

Chantix, along with other new “blockbuster” drugs such as Vioxx and Vytorin, were more or less indicted after tests and reports brought unknown risks to light, and all of them made billions in profit before negative news rained on their parade.

Rep. Waxman, who becomes chairman of the House of Representatives Energy and Commerce Committee when the new Congress convenes in January, has expressed his interest in revisiting the drug ad issue.

“It is these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a Prescription Project conference.

Merck’s blockbuster anti-inflammatory drug Vioxx was taken by approximately 20 million people before its risk of cardiac events became known. Likewise, millions of people took Vytorin before one test exposed it as a dud and another a possible cancer risk. And still millions more took Chantix before researchers understood the risks the drug posed for depression, suicide, and other serious side effects. Chantix now tops the list of the most dangerous drugs available in the U.S.

To help ease the dangers posed by new medicines, Congress sought last year to give the FDA the authority to ban the television advertising of new prescription drugs for as long as three years if it was deemed necessary to protect the public. The ban would not be a blanket ban on all new prescription drugs, but would be enacted on a case by case basis.

Exaggerated benefits and minimized perception of side effects are two pitfalls of DTC advertising for the general public. Excessive prescribing is another, but that seems to be the whole point, at least from the drug manufacturers’ point of view. Television ads for new prescriptions aren’t made with the public’s good in mind. They’re made to maximize profit. Advertising for profit is the American way, but when it amounts to messing with the health of millions, clearly some restraint is needed.

According to a report by Reuters, drug makers claim that their ads are informative to the general public. They say they have adopted voluntary guidelines which make them refrain from advertising for “an appropriate amount of time” so that doctors can be informed of the new drugs first.

An example of such restraint is Merck’s marketing of the diabetes drug Januvia.

According to Reuters, “the product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of [Januvia] to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”

Whatever restraint is exercised, no time is wasted in infiltrating the market.

The 2007 attempt to reign in advertising for new drugs failed after some lawmakers objected it would violate constitutionally protected free speech. Congress instead granted the FDA authority to fine drug companies for false or misleading advertising.

Now the country is seeing a near-perfect reversal of the 1990s trend. The number of new cancer cases has shrunk nearly one percent on average from 1995 to 1999. The death rate among cancer victims has decreased by nearly two percent from 2002 to 2005.

Researchers attribute the decline in cancer to a parallel decline in smoking, noting that cancer mortality rates would have remained virtually unchanged if Americans hadn’t quit and refrained from starting in larger numbers as they have been doing.

The Centers for Disease Control and Prevention (CDC) released a November report showing that nearly 21 percent of adults smoked in 2004. However, in 2007, the number of adult smokers dropped to under 20 percent.

It’s true that the smoking cessation market has exploded in the last 15 years with a remarkable number of gums, patches, devices, and prescription drugs. And, although more and more people continue to quit, the drop in smoking appears to be tethered to prevention and social initiatives more than anything else.

So just what are the most effective ways to slash smoking rates? Make smoking costlier by hiking tobacco taxes and make it more inconvenient by banning it from public areas, researchers say. Educating young people and providing counseling during smoking cessation are also effective ways to keep the smoking numbers down.

A lot of people may argue that a smoker has enough willpower to smoke no matter how inconvenient and expensive it becomes. As someone who used to smoke, I agree with that argument. But I also know that the growing inconvenience was accompanied by the growing aggravation of constantly having to plot and plan ahead and work around the rules and worry, often in advance, about the next opportunity to light up. And that in turn nurtured the resentment of being enslaved by cigarettes … of being trapped and ever aware of the lingering panic. I believe these feelings impelled me to quit. I’d probably still be smoking if I were allowed to light up any time anywhere and not worry about what other people thought.

California is an example of just how effective well managed anti-tobacco programs can be. While cancer rates and deaths climbed everywhere else in the mid- and late 1990s, they declined in California. In 1990, California became the first state to implement a broad anti-smoking agenda. Consequently, cancer death rates fell nearly three percent a year from 1996 to 2005.

Is Chantix playing a role in these downward trends? It’s too early to tell. The drug has been on the market for just over 2 years, but already some studies show that the drug isn’t any more effective than the patch in helping people quit smoking for a year or longer. It will be interesting to track the success of Chantix and the impact it has, if any, on smoking and cancer rates in the years to come.

Sources: USA Today

Chantix became available in the UK in December of 2006. Since then, nearly 400,000 prescriptions for the drug have been written.

Karen McGhee, a resident of Greenock on Scotland’s western shore, was one of those Chantix users. McGhee had been taking Chantix only a few days when she attempted to kill herself.

The McGhee’s daughter found Karen and ran to get her father’s help, shouting that her mother had hung herself.

“I just got woken up with my daughter dragging me out of my bed to come downstairs,” Karen McGhee’s husband, Robert, said.

He found his wife hanging from the stairs in the hall of their home.

“I ran downstairs and Karen was on the floor on her knees with a pelmet round her neck. I tried to lift her up to free the knot, but I couldn’t get it loosened. I managed to cut her free and take the noose off her neck,” he told the BBC.

“I just couldn’t comprehend it. I thought I was dreaming.”

Karen McGhee spent several days in the hospital hooked up to a ventilator before finally recovering from the incident.

She vowed to avoid Chantix in the future. “I’ll never put myself through that again and never put my family through it again. I’ll always be a smoker, or, if I quit, then I’ll quit naturally,” she told the BBC.

Another Chantix-related incident occurred in the city of Manchester in northern England. Omer Jama, who the BBC describes as a “young Manchester man,” slashed his wrists. His brother Ali called the incident “a random act, completely out of character, that took an instant.”

Omer Jama did not survive the incident. He did not leave a suicide note and his death was not recorded by the coroner as a suicide.

According to Ali Jama, the coroner recorded Omer’s death with an open verdict rather than issuing the verdict of suicide because forensics revealed Omer had Chantix in his blood at the time of his suicide.

The coroner researched the toxicology results and learned of the possible links between Chantix and suicidal behavior.

More than 3,000 people have reported adverse reactions to Chantix across Britain. 260 of those reactions have been classified as suicidal in nature. 16 Chantix users attempted suicide and 10 killed themselves, the BBC reports.

Zug.com, a reader-powered comedy website, announced a contest it is holding for the most hilarious Chantix story. The person who submits the funniest account of his or her Chantix side effects will win $500.00 — enough money for another 5 months of prescriptions.

As bizarre as the contest sounds, Zug.com isn’t joking.

“We looked at all those side effects and we thought: pure comedy,” said ZUG.com editor-in-chief Sir John Hargrave in a statement. “In the bizarre dreams category alone, there’s just incredible humor potential for our site.”

A webpage for the contest, which runs through November 2008, asks, “Have you tried Chantix? Did you experience weird dreams, strange side effects, or violent mood swings? Write up your funniest description of the weird dreams or bizarre side effects of quitting smoking on Chantix, then submit them …”

It should be interesting to see how this contest is received by the public. Chantix was linked to more reports of adverse reactions and death than any other drug in the first two quarters of 2008. Controversy continues to escalate and broaden as the drug’s safety comes under close scrutiny by the Food and Drug Administration and is prohibited or banned outright by some government and professional organizations.

Irreverence is often a big part of comedy. The ability to laugh at one’s self is tantamount to (and nobler than) laughing at others. Still, though, it seems like there may be a line here that has been stepped on, if not crossed. Can Chantix reactions really provide fodder for the comedy mill? Are the side effects really a laughing matter?

The dramatic increase of pharmaceutical drug related injuries occurred in the first three months of 2008, during which time 20,745 serious side effects and more than 4,800 deaths were reported. The incidents represent a 38 percent rise over the previous four quarters and constitute the single highest spike yet recorded.

Prescription drug related death historically accounts for 16 percent of all serious cases reported. That number soared to 23 percent in the first quarter of 2008.

According to the FDA standards, a serious drug reaction is one that leads to medical intervention or hospitalization and jeopardizes the life of the user. AERS data comes from reports that are voluntarily submitted by medical professionals. The data is generally regarded as a small representation of a much larger picture.

According to ISMP, “Some of the increases in quarterly totals could represent normal variation in the flow of reports rather than signaling a long-term trend in patient safety. However, the data are compelling and should serve as one source of information regarding drug safety in the US.”

More reported serious injuries result from Chantix usage than any other prescription drug. Chantix accounted for 1,001 new cases of serious injury, including 50 deaths.

Pfizer refuted the FDA data and ISMP’s interpretation of it. “Based on [the] totality of data, we stand by the efficacy and safety profile of Chantix when used as directed,” said Pfizer spokeswoman Kristen Neese in a statement.

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.

“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.

Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.

“It appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle,” FMCSA Administrator John H. Hill said in a public statement.

Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.

Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.

Right after I read that Chantix was the culprit in several motor vehicle accidents, a couple of incidents that happened to me while I was taking Chantix and driving suddenly made sense. Last year I had been taking Chantix for a couple months when I did a couple of really dumb things behind the wheel.

First, let me explain that I strongly believe that Chantix caused the incidents, but I cannot make that claim with absolute authority. Second, I avoided alcohol completely while taking Chantix and I was not taking any other medications. Third, in my 24 years of driving I’ve had just one speeding ticket, and I’ve received a good-driver discount from my car insurance company for nearly 15 years. Now, with those disclaimers made, I’ll continue …

Incident number one occurred as I was approaching a stop sign on my way home from work. The stop sign was on a road that ran perpendicular to a busy one-way street in downtown Montgomery, Alabama. Since it was not a four-way stop, the routine was to stop at the sign, obviously, look to the right to see if any cars were coming, look quickly to the left to make sure nobody was driving the wrong way, and then right again before crossing the street. This one night, however, it’s as if I had forgotten there was a stop sign at the intersection. My business partner, who was a passenger, began beating the dashboard in a dramatic effort to make me stop. I had no idea what he was doing. At first I thought he was exaggerating playing the drums along to the radio, which would have been completely uncharacteristic of him. It wasn’t until I was right on the sign that he yelled “STOP!” I stepped on the brake and brought my truck to a head jerking, tire screeching stop.

Even worse, instead of looking to my right for traffic barreling down the one-way street, I looked to my left, where there would have been no oncoming traffic. Only “passed” traffic. Just as I began to cross the street with my attention fixed in the wrong direction, my partner yelled “WHAT ARE YOU DOING!?”

“Good question,” I mumbled because I felt like a freak. I thought “What IS wrong with me?” as I continued on.

A few days later, on the same route home from work, alone, I came to a red light at a 4-way stop. A jeep pulled up beside me in the right lane. I sat at the light, waiting for it to turn. Meanwhile, I stared blankly at a traffic light far off in the distance. When I saw the lights turn green 3 intersections ahead of me, I proceeded to go even though my light was still red. The car next to me blared its horn, but I didn’t know why until I looked back and noticed that he was still sitting at a red light. Luckily, no cars were traveling across my line of traffic.

As I drove on, I was very startled that I had done yet another really stupid thing. The idea that I was losing my mind and driving like an idiot as a result made me panic. For some reason, it never occurred to me that Chantix might be the culprit.

Which underscores my point. I was taking Chantix in late 2007 – early 2008, just as warnings about suicide and depression began to emerge. Luckily, I never experienced those symptoms to any degree higher than an occasional but brief pity party or bout of negative thinking. A couple friends told me that I seemed quieter than usual, and I do think that Chantix made me feel somewhat antisocial at times, but thankfully I never experienced long, deep bouts of depression. Had the warnings on the label indicated that I could experience mood swings, moments of confusion, and disorientation, I would have been much, much more cautious about when and how I used Chantix.

I took Chantix for 16 weeks – a month longer than the FDA-recommended 12 weeks. Immediately after my final prescription ran out, I felt dramatically better. I had more clarity and focus and loads more energy. It was easier to wake up in the morning and wake up in a good mood. The side effects of Chantix had crept up on me so subtly and gradually that I had forgotten what it was like to be myself. I have not had any unusual or uncharacteristic driving experiences since I stopped taking Chantix. I haven’t become confused or suffered any lapses in judgment behind the wheel. In short, I became normal again.

So, to any potential Chantix users out there, pay very close attention to how you feel if you decide to try it. If you catch yourself feeling unlike yourself, becoming confused, feeling “foggy,” or just doing stupid things like leaving your car keys in the refrigerator, consult with your doctor! He may have suggestions for improving your experience with Chantix. Just knowing about these dangers may be enough to help prevent some mishaps from occurring.

Thomas J. Moore, an independent researcher who analyzed the safety of Chantix for the FDA, told the Associated Press that he was particularly concerned about the non-psychiatric side effects Chantix has on some users. These effects include vision problems, disturbances of heart rhythm, seizures, skin reactions, aggression, and loss of consciousness, among others. In themselves, some of these side effects aren’t deadly. However, when they occur within the context of driving or operating heavy equipment, they may be very harmful, if not fatal.

A study of “adverse events” reports conducted by the Institute for Safe Medication Practices contained the following warning:

“We have immediate safety concerns about the use of [Chantix] 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.”

In May, the Federal Aviation Administration (FAA) banned pilots and air traffic controllers from using Chantix. In August, the Federal Motor Carrier Safety Administration prohibited the use of Chantix without naming the drug specifically.

Late last year, Chantix claimed first place on a list of drugs with the most reported side-effect related problems. Traffic accidents ranked second in Chantix-related injuries, with 28 accidents directly attributed to use of the drug. Loss of consciousness, dizziness, confusion, and muscle spasms were the causes cited.

It’s important to keep these warnings in mind if you use Chantix and drive. Stay focused and alert; if you feel confused or dizzy, pull over immediately because the safety of you, your passengers, and everyone around you may be in jeopardy.

Now the FDA is paying closer attention to the potential psychiatric effects of non-psychiatric drugs. Anti-seizure medications, asthma drugs, and Chantix are some of the drugs now under watch for adverse psychiatric effects that they may have on the brain. This begs the question: Doesn’t every drug have the potential to affect the brain? Don’t medicines taken orally or by injection work by entering the bloodstream, which then delivers the drug to the target (in addition to the liver, kidneys, brain, etc.)?

According to an AP article, “Several independent experts say the safety alarms point to a gap in the FDA’s knowledge of how drugs affect the brain.” The article goes on to posit that “even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain.”

I’m not a pharmacist or a physician, yet it still seems very elementary to me. First, don’t all drugs enter to the brain via the blood to some degree? And shouldn’t this little bit of knowledge be enough to prevent such gross oversights? The more one reads about the FDA, the more one realizes how much he has assumed about the scope of the agency’s knowledge and its effectiveness.

Until the FDA establishes an effective method for accurately quantifying rarer side effects such as depression and suicide, it is seeking a way of warning patients without alarming them or scaring them away from drugs that will likely help them. “Debunking false notions of risk is just as important to the public health as knowing about risks that exist” Kelly Postner, a researcher at Columbia University, who is working to develop a psychiatric screening system for people receiving trial drugs, told the AP.

Perhaps in the future we can expect a warning on all medications akin to the blanket warnings about peanuts and tree nuts found on food labels. The risks may be small for the vast majority of people, but no warnings can be exaggerated for the rare exceptions whose lives have been hurt or destroyed.