Up In Smoke: Pfizer’s Chantix Raises Heart Risk
6 CommentsBy Ed Silverman // June 16th, 2011 // 10:57 am
Yet another problem for Pfizer and its controversial smoking-cessation drug. The FDA has just decided to add a warning on the product labeling about an association with a small, but increased risk of cardiovascular adverse events in patients with cardiovascular disease. These are people who, of course, should not be smoking, but they are now being told the drug may be off limits.
In reaching its decision, the FDA reviewed a study in which 700 patients with cardiovascular disease received either Chantix or placebo, and the results showed the Pfizer drug was effective in helping them quit smoking and remain abstinent for up to year. But Chantix was also linked more frequently to “certain events, including heart attack” (here is the statement and data summary).
This is only the latest difficulty for Pfizer and its Chantix pill. For the past four years, the drug has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this and this). The FDA subsequently imposed a risk management program and Pfizer added warnings.
In recent weeks, there was controversy over whether Pfizer correctly reported side effects to the FDA, which required the drugmaker to alter its methods for submitting the data (look here) and France removed from its register of medicines for which patients can be reimbursed from government funds (see this).
cig smoke thx to jo naylor on flickr
Steve Knows
Phil Harris was right!
John Q
What a shame for the innocent victims of yet another Pfizer killer scam! What do all the great “smoking cessation experts” that blamed the victims of this deadly drug say for themselves now? Oh I am sure they will also blame bad data for the way they have mocked patients and blamed the victims of Chantix. This is another reason we do not need key opinion leaders blogging away about a wonder drug.
And the paid associates for Chantix played a fun little internet blog game and pretended to be quit smoking experts who cared and not paid talking heads. Take heed internet game players and believe this is not a game. Their paid ignorance and sponsorship could mean the difference of life and death to an unsuspecting patient. I hope they all pay for this sin.
Sceptic
I guess the warning is only 5 years too late :
The FDA safety reviewer Josefberg noted in 2006 at the time of priority approval: “The serious adverse event data suggest that varenicline may possibly increase the risk of cardiac events, both ischemic and arrhythmic, particularly over longer treatment periods.”
He was overruled
(1) Josefberg H. Clinical Safety Review: Varenicline tartrate. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research; April 3, 2006
TERRI
…time for a Chantix recall!!!!!!!!!!
Thorpe
Just out of curiosity how many people commenting have either taken this drug, or smoke? I’m currently using Chantix, and have had zero side effects other than gas.
I’m curious to know what other, if any, drugs, the victims of Chantix had been taking? I could see where depressants on top of Chantix maybe bad, but that’s it.
As a smoker who is desperate to quit Chantix truly is a wonder drug.
TERRI
I took two scripts of Chantix back/back between Oct. ‘06 and Oct. ‘07. Endured two, long, painful hospital stays in ‘08.
Prior to taking Chantix, was on Zoloft for 10 years for mild depression.