Health Canada

Last month we reported that Health Canada was preparing to strengthen warnings on Chantix labels. However, Health Canada still has not taken action.

In a report by the Canadian Broadcasting Corporation, Health Canada sent the CBC an email saying that “new advice for health professionals and Canadians will come in the near future.”

Meanwhile, Chantix continues to jeopardize the lives of many Canadian citizens, some of whom are not aware of the drug’s risky side effects.

According to the CBC report, Hamilton resident Erin Kerr had been taking Chantix for two months when she realized her personality had shifted and she had become intolerant, argumentative, and emotional, all of which were unlike her usual self.

Then one day the changes became even worse. Kerr found a sudden irrational appeal in taking her own life. She described her experience to the CBC.

“As I’m driving along the [Hamilton] mountain brow, I just thought that driving off … would have been the easy way out at that point and would solve all my problems,” she said.

Fourteen-year-old Ellaina Janewicz lost her father Thom Janewicz early last month when he committed suicide. His ex-wife, Gayle Nakamoto, said that Thom had struggled with depression in the past, but that it seemed to be “under control.” Thom was a 48-year-old engineer and was about to begin a new job when he started taking Chantix.

Ellaina keeps a journal to help her cope with her loss. She read an excerpt of it to the CBC.

“What will I do now? I have no father,” Ellaina said, reading from the journal. “I’m here with my mother alone and my brother. I’m very confused. I’m not sure what to do.”

In the United States, the Food and Drug Administration strengthened its warnings a year ago. Despite the new warnings, however, the FDA still received more reports of adverse effects linked to Chantix use than any other drug.

SOURCE: Chantix Recall › More Canadians harmed by Chantix as government revises warnings

The decision to turn the volume up on Chantix warnings follows several months of reports linking the drug to a slew of negative side effects. Feeling unusually agitated, depressed, or hostile are some of the effects commonly reported. Sudden changes in behavior, impulsive or disturbing thoughts, and the desire to hurt oneself or others are some of the more serious reactions reported.

In the United States, the Food and Drug Administration received more reports of serious injuries arising from Chantix than for any other drug. Prescription drug related death, which normally accounts for 16 percent of all serious reactions reported to the FDA, soared to 23 percent in the first quarter of 2008, largely because of Chantix. The U.S. has since strengthened warnings on Chantix labels.

Health Canada says that while Chantix can be an effective aide in quitting smoking, users of the drug and their families should closely monitor behavior for any changes. Sudden shifts in mood, depression, aggression, and thoughts of self harm are red flags that everyone should watch for. The person taking Chantix should avoid driving and operating heavy machinery until they know that Chantix does not have any adverse effects on them, Health Canada recommended.

Pfizer’s spokesman in Canada, Christian Marcoux, said that Chantix is safe and that some of the adverse side effects are actually caused by quitting smoking.

SOURCE: Chantix Recall › Canada strengthens Chantix warnings

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.

SOURCE: Chantix Recall › The Chantix experience: salvation, downfall, or just plain strange?

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.

SOURCE: Chantix Recall › Researchers recommend new Chantix warnings

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.

SOURCE: Chantix Recall › Chantix and driving: my experience

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.

SOURCE: Chantix Recall › Chantix played role in traffic accidents