Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts. A Black Box Warning is the Food & Drug Administration’s (FDA) most serious safety notice.
It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated 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 a Black Box warning.
The FDA said today that new Black Box Warning for Chantix and Zyban was based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature. According to a report in The Washington Post, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.
In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped. The agency also said that some of the problems could have been the result of nicotine withdrawal, however many of the reported events occurred while patients were still smoking.
Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid. In today’s announcement, the FDA said similar information on mental health events will be required for Wellbutrin and its generic equivalents. These drugs already carry a Black Box Warning for suicidal behavior in treating psychiatric disorders.
The FDA said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.
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July 1st, 2009 at 4:26 pm
First the Percocet and Vicodin problems and now this. Time for changes at the FDA. There is a related post at http://iamsoannoyed.com/?p=2020
November 11th, 2009 at 12:26 pm
I have been struggling since 1999 when I was first prescribed Zyban by the Military. It is widely used and the side effects are not new. I was prescribed Zyban a few different times since 1999 and finally had a severe reaction in Jan 2009 when I began researching it myself. I followed all instructions, including NO alcohol. It has been an extremely frustrating battle since my Security Clearance is in Jeopardy since the Doctors DID not follow FDA guidelines when syptoms arose but instead kept me on Zyban and diagnosed me with behavior disorders. Now after recovering, I have fight to rebuild my civilian career and my Military Career seems forever destroyed due to Doctors not following FDA guidelines FIRST. IT IS THEIR JOB to know what the FDA says about ANY medications they administer or monitor. It is why we have to pay them so much and they have to be Government Certified
November 17th, 2009 at 1:06 pm
‘m a 55 yr. old wife (35 yrs.) and proud na na of 6! Love my job (22 yrs.), play in Sunday afternoon softball league w/my sisters, love long walks, dinner monthly w/grade school buddies, etc. In other words, everything to live for!
filled two Chantix scripts between Oct. 2006 and Oct. 2007. (wanted to kick 3 – 6 cigs per day habit). Followed directions to a “T.” As promised, I quit smoking because it no longer satisfied me!
Jan. ‘08 – - taken by ambulance in middle of nite w/heart attack symptoms, horrible headache, severe stomach spasms and fever of 104. Put on oxygen, morphine and antibiotic IV. Stayed a week. Written off as “possible virus.”
May ‘08 – - had GREAT day at work! Daughter called when I got home and said, “I’ve been elected to tell you, you’ve changed, mom…”
Thought, hmmmm…ok, well, I don’t have to put up w/this…hey, it’s a good nite to die! My job is done here! Wasn’t mad, sad, glad,…NOTHING…I felt like all I wanted to do was leave. I’ve paid my dues and I’m tired!
Took long drive to rural area. Along the way, purchased 3 bottles of sleeping pills and little diabetic mini-razors (I didn’t even know they MADE such things)…much less understand why I even BOUGHT such a thing..but, I did. Sang w/radio on way to final destination. Found a quiet, used car parking lot and parked on an angle to blend in.
Wrote extremely short note…downed over 240 pills and bloody razors were found all over parking lot and inside car next day. My keys were in front of my car, so apparently I walked around outside during the nite.
Woke up 6 days later in ICU surrounded by family. Last rites had been given. I woke up when being removed from respirator/ventilator. I could hear doctors telling my family that if I lived, I would probably be brain dead, need diapers, long-term, institutionalized care, liver transplant, etc…
Thought, certainly they can’t be talking about ME! My grandson, Joey has a teeball game Saturday. I don’t have time for this!!!
Spent time in psyche unit. Babysitting privileges were taken away. Was ostracized by those closest to me. They couldn’t believe I was capable of doing something this crazy! Well, hey, neither could I!!
Learned months later about side effects of Chantix. I pray for my day of vindication. I really, really, do…