Posted on 04/18/2008 6:11:40 AM PDT by Diana in Wisconsin
Melinda and Kenny Peterson wanted to kick their two-pack-a-day smoking habit.
In early January, the Green Bay couple started taking three-month prescriptions of Chantix, a new anti-smoking pill. About six weeks later, they weren't smoking at all.
But what the Petersons didn't know was that as they were weaning themselves off cigarettes, the U.S. Food and Drug Administration issued an alert: Some patients taking the powerful drug had experienced serious neuropsychiatric symptoms. And Pfizer, the maker of Chantix, had recently added a warning about these symptoms in a more prominent position in the drug's information packet, at the FDA's urging.
The alert was issued in early February. But the Petersons didn't know about it until the end of March, when a friend who was a pharmacist filled them in.
By then, it was too late. About a week earlier, Kenny Peterson had spiraled into a deep depression. He told his wife he wanted to kill himself. His family checked him into a hospital psychiatric ward four days before Easter.
Chantix's safety is now under fire, as similar stories of patients with suicidal thoughts, depression and aggressive behavior surface. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. The FDA also said it "appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms." About 5 million people use the drug.
"I think the jury is still out on what's going on here," said Carlyle Chan, a professor in the psychiatric department at the Medical College of Wisconsin. "Be aware that there are some concerns about (Chantix). It needs to be watched closely."
A Pfizer spokeswoman said the company was rolling out Chantix globally but halted advertising the drug to consumers in February. The FDA approved the drug in May 2006.
The company maintained that the serious neuropsychiatric symptoms are rare, but physicians and patients should be on the lookout for them. Pfizer said a causal relationship between the drug and these symptoms has not been determined.
"The real problem out there right now is smoking," Senior Vice President and Chief Medical Officer Joe Feczko said at a health investor conference in March.
Chantix can help shrink the global population of 1.3 billion smokers, he said, thus addressing health problems such as cancer and cardiovascular disease. In 2007, Chantix brought in $883 million in revenue.
Chantix, known generically as varenicline, works by blocking nicotine receptors in the brain. When people smoke, nicotine attaches to receptors and the brain releases the chemical dopamine, which gives pleasure. Chantix activates the receptors and blocks nicotine from attaching to them.
The drug now includes a mention of possible serious neuropsychiatric symptoms in a warning section of the printed information that accompanies each prescription and is folded inside the packaging. Previously, the information was in a less prominent place in a section of the drug's literature in which "adverse events" were reported. But there is no requirement to put the warning on the actual package because the FDA hasn't mandated it.
None of this is comforting to Melinda Peterson, who believes that Chantix cost her family too much.
In the psychiatric ward, Kenny Peterson was diagnosed with bipolar disorder. He's out of the hospital now but can't work, and his doctors said they wouldn't know when he would be able to work.
"He is completely mentally ill right now," Melinda Peterson said. "My belief is that the drug caused him to go into a manic episode. He has paranoia. He has delusions."
Chan said it was unclear whether Chantix actually caused depression and suicidal thoughts or whether Chantix exacerbated the symptoms of people who already have some sort of depressive behavior.
The FDA reported that it has seen both types of situations - some in which patients had no history of depression, and cases in which depression previously was an issue.
Ping-a-Roonie.
The Voices say I am fine.
Well, if you take this drug and kill yourself they can count you as an ex-smoker.
Quitting smoking can make folks exeedingly anxious and depressed.
I have used Chantix. It is truly amazing in its ability to suppress the desire to smoke. However, it screwed my sleeping patterns up with persistent nightmares. I’m not talking about bad dreams, i’m talking about night terrors.
Didn’t hear any voices or want to commit suicide, just wanted some sleep. This drug affects the pleasure sensors in the brain so it doesn’t suprise me that it can cause depression or suicidal thoughts in some folks. They are on the right track with Chantix, but the drug and its active elements need to be refined a little more.
Kenny could run for governor of Wisconsin...it’d be a step up for the state...
Well, to the anti-smoking nazis who have infected governments at all levels, no price is too high a price to get someone to quit. So, according to them, this is a complete success.
It remains to be seen, however, if the governments are able to figure out how to sue both the tobacco companies and the anti-smoking-drug companies billions, to fund their socialist nanny-state programs.
Great....Hubby just started taking it Wednesday.
Bookmarked for Hubby to read.
New ad campaign:
If the smoking doesn’t kill you, Chantix will.
I didn't have nightmares but I did have persistently vivid dreams.
I think this would be a case, like the article suggested at one point, that this may exacerbate something already there.
I'm not a depressive person either and the drug did not cause it in me.
Yeah, suicide will do that.
Night terrors? I'd rather smoke.
“I have used Chantix. It is truly amazing in its ability to suppress the desire to smoke. However, it screwed my sleeping patterns up with persistent nightmares. I’m not talking about bad dreams, i’m talking about night terrors.”
Dittos. Don’t get me started on the mood swings and overwhelming unwarranted feelings of dispair.
And while I don't want to diminish the deaths, 37 suicides is not alot if you consider 5 million prescriptions for Chantix have been written, with three million users currently on the program (that number was verified at Feb 2008 FDA conference).
Also at that first link, it states "While it has been reported that some problems involving Chantix were complicated by the consumption of moderate to heavy amounts of alcohol, it has been reported that an almost equal number of Chantix users experienced difficulty, though alcohol was not consumed.", so that brings the actual number of deaths that can be attributed to Chantix alone down even further. Your risk of being hit by a car walking across the street today are higher and certainly your risk of smoking related death is significantly higher.
Aw heck...that was probably just a nicotine fit.
“on the mood swings and overwhelming unwarranted feelings of dispair.”
I took it for a few days and fell into the deepest, darkest pit of depression I’ve ever experienced. It was so profound that I knew exactly what was causing it.
I quit taking the Chantix and in a day or so I was fine.
OTOH it worked great for my wife.
Quitting smoking invokes a whole raft of unpleasant results. The hold tobacco has on a smoker, is a true addiction - some ex addicts, have even said it was easier to quit heroin, than tobacco.
The end is worth the means, but it’s not a happy time for the smoker, while transitioning to new life as ex-smoker.
Could be, this new drug is so effective, it compresses all those unpleasant feelings one goes through during the process of quitting, into a short and wobbly period of time, resulting in the reported effects.
Quitting is still worth it. Absolutely no question.
Just more 21st century whining, IMHO.
Some of these drugs have side effects worse than what they purport to cure.
Do you feel self conscious? to you feel socially awkward at party’s?
They new Tohellwithital!
Side effects may include impotence,incontinence and blindness.
You’ll be able to pick up babes but will crap yourself when you cant get it up, but hey! you wont have to look at what a wreck you’ve become!
This is troubling to me because I know a man who already had a serious tremor based in a long-term neurological problem.
It has clearly HELPED his neurological problem.
His case is so extraordinary and important that he is now being filmed and evaluated on the possibility that this side effect may help hundreds or thousands of other disabled people.
I hope in the initial panic about people who may have been harmed that this drug is not entirely banned.
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