CHICAGO (May 8) — The federal government’s new advice to doctors for helping smokers quit recommends the drug Chantix, which has recently been linked with depression and suicidal behavior. The new guidelines mention the psychiatric risks but also say the popular Pfizer Inc. drug is the most effective at helping people get off cigarettes.

The guidelines mention other options, too, and highly recommend combining counseling and medication. But doctors are encouraged to talk to all smokers who want to quit about trying medication.

Consumer advocates cautioned that the safety picture on Chantix is incomplete because it’s a relatively new drug, on the market just since 2006.

“It is somewhat better than other therapies; on the other hand, it appears to have more risk,” said Dr. Sidney Wolfe of the watchdog group Public Citizen. “That part of the risk-benefit equation is missing, and it’s changing rapidly.”

Another issue with the quit-smoking guidelines, released this week by the U.S. Public Health Service, is the lead author’s past connections with Pfizer. Dr. Michael Fiore, an expert on smoking and health issues, was a consultant to the maker of Chantix. But he said he cut those ties in 2005.

Fiore’s views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the site advocating quitting “cold turkey,” called the revised guidelines “a sales pitch” for the drug industry.

The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don’t reflect how it’s used “in the real world.”

“People are quitting smoking to save their lives,” Polito said. If Chantix’s risks outweigh its benefits, “then it’s insane for people to risk their lives” by using it, he said.

So what do you think is the risk worth it?

Do you know of anyone that has either a positive or negative experience with this drug?

Recently at a speaking engagement in Chicago, I met a user that quit smoking using the drug but refused to proceed to the fourth step as he feared the side affects  that he was experiencing.

Whose side are you on that of Fiore? or Polito?

Share your thoughts!

Let others know your opinion!


#1 TAZ on 05.13.08 at 12:19 PM

Found a very interesting article today that supports going “cold turkey”.

United States
A survey of US smokers conducted by market research group Mintel found that 74% of the respondents said they quit smoking by going cold turkey, while 8% gave up the habit by using nicotine replacement therapy (NRT) products like gums and patches, 6% by cutting back on cigarettes and 4% with the help of an oral prescription medication. (Business Wire 05/08)

#2 TAZ on 05.22.08 at 4:11 PM

The US Federal Aviation Administration said it is banning airline pilots and air traffic controllers from using Chantix because the reported side effects could pose a threat to the safe operation of aircraft.(New York Times – NYT 05/22

#3 TAZ on 05.22.08 at 4:14 PM

New safety concerns for Pfizer Inc’s Chantix could worsen the already declining sales of the smoking cessation drug and lead to legal trouble for the pharmaceutical company, which has twice updated Chantix’s label for potential side effects since its was approved in May 2006, analysts said. (Dow Jones 05/22)

#4 Johnie Jay on 05.23.08 at 12:48 AM

As mentioned in another spot a buddy had his doctor recommend Skoal pouches as a way of quitting smoking! He quit smoking!

#5 Jersey Guy on 05.30.08 at 11:11 AM

Hey Lou just wanted to tell you that the article you wrote in Convenience Store Decisions – May edition was great! I think your right on target!

#6 Anonymous on 06.25.08 at 3:21 PM

i used Chantix successfully for about 3 months. I found the product to be good at alleviating the desire for nicotine specifically, but bad at keeping me feeling like my normal self (or the self i knew when I was smoking).

While on chantix, I did not experience any depression or any real side effects…but I did feel off and a bit mentally lost. After stopping usual dosage 2 months into using it, I was able to stay off cigarettes for another month after.

The reasons why I went back to cigarettes, I believe, aren’t because Chantix wasn’t effective…but due to the reasons people start/resume smoking – habit/peers/social settings, etc.

However, I do feel like the drug was effective while I was taking it.

#7 Jersey Guy on 07.03.08 at 4:31 PM

Saw on the news that GSK is re-attacking the cessation business lost by Chantix. Seems Pfizer business is down 33%. Interesting comment was made that the Chantix noise is causing loss sales in other cessation products also.

#8 SMOKEY on 07.20.08 at 2:12 AM

My neighbor used chantix and was doing really well and then all of a sudden began to have strange feelings of depression and ended up quitting using the drug when he woke up one night with thoughts of suicide. Amazing to still find the FDA allowing the use of this drug. It makes me really wonder how the FDA would ever be able to control the tobacco industry but then I realize it will most likely refer to it’s partner – Philip Morris.

#9 Troubadour on 07.27.08 at 12:53 PM

I find it ironic that Big Tobacco pays govt to then go pay Big Pharma to produce products that don’t work! Or possibly are more deadly! Pretty interesting!

#10 TAZ on 08.14.08 at 6:03 PM

United States/Japan: Yokota Air Base Pharmacy Pulls Chantix
Medical officials at the US Air Force’s Yokota Air Base in Japan decided to remove Chantix from the base pharmacy, after a May report from the Institute for Safe Medication Practices found an array of health and safety concerns including falls, heart rhythm disturbances, heart attacks, seizures, diabetes and psychiatric disturbances associated with the smoking cessation drug. Yokota has suspended all refills of Chantix, but 374th Medical Support Squadron pharmacy element chief Major Tam Dinh said a patient with approval from his doctor can continue the medication and special order the drug. Chantix, however, is still available in many military smoking-cessation programs in the region, although air crew members can no longer take the drug as per the US Department of Defense’s (DOD) recommendation that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.” In South Korea, where Chantix is available at military treatment facilities, Major Remington L. Nevin said individual healthcare providers are free to exercise their judgment in determining whether their patients should be treated with Chantix. He noted that the DOD recommendation currently does not prohibit the use of Chantix or mandate a formal screening process before prescribing the medication. The medical community at US naval hospitals Yokosuka and Okinawa in Japan are taking a similar approach, leaving the decision about Chantix to the patient and the physician (Stars & Stripes 8/12).

#11 TAZ on 09.26.08 at 5:47 PM

Found this on the TMA site – (also on the blogroll)

Prof. Michael Siegel of Boston University School of Public Health said the national recommendation that Pfizer’s Chantix and other smoking cessation drugs be used to treat nicotine dependence in all smokers, despite its potential adverse side effects, comes from a panel that had severe financial conflicts of interest, including the panel’s chair Dr. Michael Fiore who has lectured and consulted for Pfizer and eight other panel members who have received or are currently receiving funding from pharmaceutical companies. The extensive conflicts of interests may have contributed to the magnitude of the problems surrounding Chantix, including its side effects and the lawsuits that have been filed by families of smokers who say their loved ones committed suicide as a result of taking the drug, Siegel writes ( 09/24)

#12 Jersey Guy on 09.27.08 at 10:59 PM

According to an article in Lawyers USA, there are now at least 200 lawsuits that have been filed by the families of plaintiffs who allege that their loved ones committed suicide as a result of taking the smoking cessation drug Chantix (varenicline) or by plaintiffs who attempted suicide after starting Chantix. These cases were filed by a single law firm, which is investigating another 1,200 cases. Another firm is investigating 175 similar cases.

The plaintiff’s attorney was quoted in the article as describing the cases as follows: “”Tragically, almost without explanation, these people commit suicide, often without any prior diagnosis of family or individual history of depression, psychosis or any other type of psychological conditions.”

#13 TAZ on 10.25.08 at 1:27 PM

Another article from TMA site and Michael Siegel –

Prof. Michael Siegel of Boston University School of Public Health said the Institute for Safe Medication Practices’ report revealing that Pfizer’s smoking cessation drug Chantix accounted for more reported serious injuries than any other prescription drug brings to light the “potential tragedy related to the fact that national recommendations that all physicians use drug treatment for all of their patients and the recommendation of Chantix for this purpose were made by an expert panel that was chaired by a researcher with a history of severe financial conflicts of interest and that included numerous others with financial interests in pharmaceutical companies.” ( 10/23)

#14 TAZ on 07.02.09 at 5:29 PM

Here’s an update:

The Food and Drug Administration on July 1st required Pfizer and GlaxoSmithKline to place “black box” warnings, the agency’s most serious caution, on the prescribing information for their smoking cessation drugs Chantix and Zyban, respectively, noting their risk of serious mental illness including suicide. (New York Times – NYT 07/01)

#15 LOU on 04.21.11 at 1:21 PM

Chantix: Why the Black Box Warning is Not Enough and Drug Should Be Removed from the Market
Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

The black box warning for Chantix notes the following:

“All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. … Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior.”

The black box warning, then, advises physicians to observe patients being put on Chantix for “suicide-related events,” including “suicide.”

This simple question comes to mind: What use is it to observe patients for suicide? In what way does that protect the consumer? If a side effect of the medication is committing suicide within days of initiating therapy, how is monitoring the patient for suicide going to help?

The FDA itself has reported a typical case of Chantix-associated suicidal ideation as follows: “A 30 year-old female reported that she was taking varenicline 0.5 mg/day to help her quit smoking. She indicated that she had taken the pill for 5 days as directed. In her report, she stated, ‘I became very depressed for no apparent reason and started having suicidal thoughts. I worried that I was going to hurt myself or someone else. I was also in a state of panic and unable to eat. I thought that I might go crazy and felt completely out of sorts. I quit taking the pill. About 36 hours later, I felt like myself again.'”

Fortunately, this woman stopped taking the medication. However, the story could easily have been different. Instead of stopping the medication, she could have instead attempted or committed suicide in response to her suicidal ideation. Monitoring patients like this for suicide attempts makes no sense. The purpose of monitoring is to prevent these adverse consequences -especially death – from occurring.

There are three situations in which a black box warning can be effective in protecting consumers. I will describe each of these situations and show why Chantix does not meet any of these criteria:

1. Early Detection of Side Effects Can Prevent Serious Adverse Consequences

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient’s liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect – sudden suicide – often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

2. Restricted Use of the Drug May Prevent Side Effects

A second situation in which a black box warning may be appropriate is when the severe side effects of the drug tend to occur only in certain patients. In this situation, warning physicians not to prescribe the drug to those patients can prevent the serious side effects. For example, if a drug causes blood clots only in people who are obese, then warning physicians not to prescribe the drug to patients who are obese will be effective in preventing this side effect.

This is not the situation with Chantix because its potentially lethal side effects have been observed to occur among all patients, not only those with existing psychiatric disease. In fact, FDA’s review of Chantix side effects revealed that of cases of Chantix-related suicidal behavior in which psychiatric history was known, 44% of victims had no prior history of psychiatric disease.

3. The Benefits of the Drug Far Outweigh the Costs and Despite the Severe Side Effects, Physicians Should Use the Drug if Benefits Outweigh Risks for a Specific Patient

The third situation in which a black box warning may be appropriate is if the benefits of the drug far outweigh the costs on a societal level and the warning will ensure that physicians weigh the costs and benefits of the drug for the specific patient. For example, a drug that is used to treat cancer might have a severe adverse side effect but its benefits might still outweigh this cost if there are no other treatments available and so this is the only choice that patients have. This criterion will generally not be met if there are lots of other drugs on the market that are equally effective.

In my view, this criterion is not met for Chantix because this drug is not uniquely effective. There are many other treatments on the market (including a variety of nicotine replacement medications) that are equally effective. Moreover, the overall success rate with Chantix is still exceedingly low, and in the overwhelming majority of cases, the use of Chantix will not succeed in getting the patient to quit.

Under these circumstances, I simply do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

Since none of these three criteria is met, I do not believe that the black box warning is appropriate and I reiterate my call for the removal of Chantix from the market

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