Chantix maker Pfizer Inc. has hit upon an unusual marketing strategy for the smoking cessation drug – running ads that never even name the drug.  According to The Wall Street Journal, such “unbranded product advertising” is becoming increasingly common in pharmaceutical marketing.  These types of promotions are growing in popularity because there is no requirement that they include important safety information consumers should know.

Anyone who watches television has seen Pfizer’s ad for Chantix, although they might not know it. In the spot, a middle-age woman tells the camera, “At 6:30 in the morning, I have a cigarette. And then another on my way to work.” Viewers are then directed to Mytimetoquit.com, where they can receive information on smoking cessation. Visitors to the site find a link to a Chantix site that contains information on the antismoking drug, including the negative side effects. (more…)

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning – the agency’s highest safety alert. (more…)

According to a study conducted by GlaxoSmithKline, Chantix—a smoking cessation medication recently making headlines for unusual side effects being reported in those taking the drug—is no better at helping patients quit smoking than therapeutic nicotine (TN), such as NicoDerm.  Glaxo is maker of the smoking cessation medication NicoDerm and Pfizer makes Chantix.  Glaxo’s findings were published today in the August issue of Thorax and claim there is no significant differences in six-month and one-year quit rates between the NicoDerm(R) CQ(R) Clear Patch and Chantix (varenicline tartrate), even though “statistically higher quit rates are shown for Chantix at 12 weeks.”  According to the official 2008 U.S. Public Health Service Guideline, “longer-term quit rates at the six-month milestone are the most predictive of long-term success.”

The Thorax paper, entitled, “Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation:  Results from a Randomised Open-Label Trial,” reports on a 52-week study–the first-ever direct comparison of the NicoDerm CQ Clear Patch to Chantix.  The study used an “open-label” design.  In other words, subjects knew the medications they were taking.  “This study confirms that there is no magic bullet when it comes to smoking cessation and that both therapeutic nicotine and Chantix (varenicline tartrate) demonstrate long-term effectiveness,” stated Dr. Howard Marsh, vice president of Worldwide Medical Affairs for Glaxo Consumer Healthcare.  “There is also no single approach that will work for everyone.  For example, a substantial proportion of quit attempts are made spontaneously, without much planning.  Therapeutic nicotine is widely available without the need for a prescription or a visit to a doctor’s office.” (more…)

One of the first lawsuits over Pfizer’s smoking cessation drug, Chantix, is becoming official this week.  The lawsuit alleges that the use of Chantix led David Collins of Gas City, Indiana, to commit suicide in January and that Pfizer failed to issue proper warnings about psychiatric side effects.  Collins’ widow, Linda, filed the suit Tuesday in a U.S. District Court in Indianapolis.  According to the lawsuit, Collins began using Chantix in October 2007.  Linda’s lawyer claims David had no history of psychiatric problems.

The lawsuit alleges that Pfizer purposely excluded people with a history of mental illness when it tested Chantix during clinical trials.  ”I run a clinic, and two out of three (smokers) I see have psychiatric or mood problems,” Dr. Daniel Seidman, director of Smoking Cessation Services at Columbia University Medical Center, is quoted in the suit.  The suit also alleges the active ingredient in Chantix was derived from cytosine.  Cytosine has been linked to suicide and the suit alleges Pfizer should have known about that link based on documentation dating back over 30 years.  The suit also alleges Pfizer historically delays publication of scientific papers if such papers contain results unfavorable to the marketing of its products.  The Institute for Safe Medication Practices recently reported that it has received notice of nearly 1,000 serious side effects related to Chantix. (more…)

Following revelations that it enrolled combat veterans with Post Traumatic Stress Disorder (PTSD) in a Chantix trial without warning participants of the drugs’ suicide risks, the Department of Veterans Affairs is now reviewing drug protocols for such veterans.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. (more…)

A lobbyist for Pfizer – once the head of the Department of Veteran’s Affairs (VA) – contacted his old agency about keeping Chantix on its drug formulary, even after the smoking cessation drug was linked to suicides.  According to the Washington Times, former VA secretary Anthony J. Principi contacted his old colleagues earlier this year, shortly after the federal government banned pilots and air traffic controllers from using Chantix.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. (more…)

The Department of Veterans Affairs (VA) was warned by its own doctors in 2007 that some veterans using the smoking cessation drug Chantix had experienced psychotic episodes and other bizarre behavior.  Yet it wasn’t until last month that the VA informed veterans using Chantix that the drug was linked to suicide and other psychiatric side effects.

A few weeks ago, ABC News aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial – all diagnosed with  post traumatic stress disorder (PTSD) – had not been told that the drug was linked to depression, suicide and psychotic behavior.  According to the ABC News report, hundreds of  Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month  to participate in a Chantix behavioral study.  Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide.  It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted.  But even then, the VA’s notice didn’t specifically mention suicide. (more…)

For the second time since April, health officials in Canada have issued a warning about Chantix, Pfizer’s anti-smoking medication.  This time, Health Canada is warning that Chantix – sold in Canada as Champix – has caused unusual feelings of agitation, depressed mood, hostility, changes in behavior or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, in some users.

In April, Health Canada issued an alert warning that Chantix has been linked to 107 adverse reactions in Canada.  According to the ageny nearly half of those reports involved psychiatric behavior.  In its latest alert, Health Canada has said that in the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported in patients taking the drug. (more…)

About 32,000 veterans taking Chantix will soon receive a warning that the stop-smoking drug is linked to suicidal behavior.  The decision by the Veterans Administration (VA) comes after ABC News aired an investigative report which revealed that veterans enrolled in a Chantix trial – all diagnosed with  post traumatic stress disorder (PTSD) – were not told for several months that the drug was associated with suicide.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.   (more…)

A shocking new report alleges that war veterans used as test subjects for Chantix were not told upfront that the anti-smoking drug was linked to suicidal behavior and other psychiatric side effects.  What’s worse, some of the Iraq war veterans used as Chantix guinea pigs were suffering from post-traumatic stress disorder (PTSD), a condition that already placed them at a higher risk of suicidal behavior.

In the US, 34 Chantix users have reportedly committed suicide. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.   (more…)