Chantix Accidents and Black Outs May Lead to New FDA Warning

A new report released Wednesday by a non-profit safety group highlights a number of health risks associated with Chantix. The drug has been associated with over 1,000 reports received by the FDA involving serious problems, including a number of injuries caused by traffic accidents, seizures and blackouts that could lead to new warnings.

The Institute for Safe Medication Practices (ISMP) analyzed data involving over 20,000 drug-related serious adverse event reports received by the FDA during the first quarter of 2008.

A serious adverse event is considered one that results in death, hospitalization, medical intervention or places the users life in jeopardy.

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The group indicates that the first quarter of this year represents was the highest number of adverse event reports received by the FDA, and represents a 38% increase over the previous four calendar quarters. The substantial increase was mainly attributed to two drugs.

The first was heparin, which was recalled nationwide during the first quarter after it was discovered that the blood thinner was contaminated with a counterfeit chemical that resulted in 779 reports of serious reactions, including 102 deaths.

The other drug largely responsible for the sharp increase was Pfizer’s anti-smoking drug Chantix, which has been associated with a variety of potential side effects, including an increased risk of suicides, suicide attempts, new-onset diabetes, Stevens-Johnson Syndrome and sudden blackouts and seizures which could result in serious accidents.

The number of adverse event reports associated with Chantix was 1,001 during the quarter. This tops the number associated with the headline dominating heparin scandal, and exceeds the number of reports associated with any other drug in the United States during the quater. In addition, the true number of Chantix problems experienced during the quarter was likely more than 10,000, since estimates suggest that only 1% to 10% of all adverse events are ever reported to the FDA.

As a result of the psychiatric side effects associated with Chantix, the FDA required Pfizer to add a “black box” warning in February 2008, which is the strongest warning that can be placed on a prescription medication.

The Institute for Safe Medication Practices indicates that the adverse event reports during the first quarter included at least 15 cases of Chantix related accidents resulting in serious injury and an additional 52 cases of sudden blackouts or loss of consciousness.

In response to the report, the FDA has indicated that they are reviewing the reports of blackouts and traffic accidents among Chantix users to determine whether the warning label should be updated further.

Many advocates have been pushing for a Chantix recall given the substantial side effects associated with the drug and the limited benefits provided by the stop-smoking aid. While it is effective in promoting smoking cessation, other nicotine replacement therapies have also been found to also be effective, but are much more safe.

According to the ISMP report, there were only a combined total of 17 serious adverse event reports received among all of the other forms of nicotine replacement therapy combined during the first quarter of 2008, less than 2% the total number associated with Chantix side effects.

12 Comments

  • RhondaJanuary 27, 2021 at 8:07 pm

    I have been taking Chantix for 3 months, I am starting to experience blacks outs. I can feel it coming on so I go to bed. I end up sleeping for at least 3 hours. I can't tell about mood swings, but was I told I get angry at the small stuff. Seeing doctor in couple of days.

  • DanJanuary 11, 2013 at 4:32 pm

    After starting Chantix I noticed lapses in concentration but brushed them off. Then I blacked out while sitting on a stool (I wasn't drinking) and fractured part of a cervical vertibre. Still after going to the hospital, nuerosurgeon, and my family Dr no one thought to tell me it was the Chantix. The blackouts continued until I had another serious fall and ended up in the hospital again. After[Show More]After starting Chantix I noticed lapses in concentration but brushed them off. Then I blacked out while sitting on a stool (I wasn't drinking) and fractured part of a cervical vertibre. Still after going to the hospital, nuerosurgeon, and my family Dr no one thought to tell me it was the Chantix. The blackouts continued until I had another serious fall and ended up in the hospital again. After the second fall I was the one that figured out it was the Chantix. It's been 7 months now and I've been diagnosed with Post Concussive Syndrome and I have constant headaches and a severly impaired short term memory. My advice is for anybody thinking about using Chantix to seriously try all other avenues first.

  • RobinNovember 8, 2012 at 3:41 pm

    On Fri. Oct. 26th while sitting on my porch talking to my husband I experienced the worst headache of my LIFE. I had been on Chantix for 6 weeks and had just decided about 5 days earlier to stop taking them because they made me so sick on my stomach. The headache mentioned above got worse and worse and required that I go to the hospital ED. Upon my arrival my BP was 200+ over 100+ . I don't reme[Show More]On Fri. Oct. 26th while sitting on my porch talking to my husband I experienced the worst headache of my LIFE. I had been on Chantix for 6 weeks and had just decided about 5 days earlier to stop taking them because they made me so sick on my stomach. The headache mentioned above got worse and worse and required that I go to the hospital ED. Upon my arrival my BP was 200+ over 100+ . I don't remember the exact numbers. After several hours and many test including 2 lumbar punctures, I was transfered to a trauma center by ambulance about an hour away. Eventually the headache subsuded and I was released, but told if the headache returned to come back to the trauma center. On Sunday Oct 28 another horrific headache and I returned to the University of Virginia Medical Center and endured another L.P and numerious test again to no avail as to why I was suffering from the aweful headaches. I was admitted and the headache subsided after 2 days and I was released again with blood pressure meds this time. I have never had high BP in my life until now. On Nov. 2nd I had a follow up appointment with my personal Dr. just to have my BP checked. I had not felt well since leaving the hospital and when I got to the Dr. office the nurse checked my BP. and it was 155/88 but I ask that they check my ear because I felt the pain begining. As the Dr. was checking my ear the headache hit again and my BP shot up to the danger level again. A ambulance was called and I was taken to the local hospital where I was admitted for 5 days and was again put thru many test including serveral types of MRI's. It was decided that I need to have a biopsy done of my tempral artary. I was started on high dose prednisone, topamax, and cont. with Lisinopril. I BELEIVE ALL OF THIS IS THE RESULT OF MY TAKING CHANTIX. I HAD DANGEROUS BLOOD PRESSURES THAT WERE BROUGHT ON BY THE HEADACHES, NOT THE OTHER WAY AROUND.

  • SusanSeptember 29, 2011 at 1:25 pm

    I am on the end of the 4th week of Chantix and haven't had any issues with mood swings or vivid dreams (I have these types of dreams normally all my life) but today I have experienced 3 episodes of drop in blood pressure and dizziness so bad I am hardly able to stand and nausea all within an hour. 4 weeks ago before taking Chantix I was diagnosed with borderline diabetes (AC1 was 5.18 which is be[Show More]I am on the end of the 4th week of Chantix and haven't had any issues with mood swings or vivid dreams (I have these types of dreams normally all my life) but today I have experienced 3 episodes of drop in blood pressure and dizziness so bad I am hardly able to stand and nausea all within an hour. 4 weeks ago before taking Chantix I was diagnosed with borderline diabetes (AC1 was 5.18 which is below the normal =< .6) . Since taking Chantix I have had to have an oximeter test done which showed a drop in blood pressure below 88 during sleep. I do not know if this is related to Chantix, but if I have another dizzy spell within the next hour, I am going to the ER.

  • NancyMay 28, 2011 at 2:06 am

    I have been in AA for 15 years clean and sober.After I got out of rehab my doctor wanted to try me on chantix to stop smoking. I never saw from the oustside with everyday emotions and dealing with the public that I sank into darkness until on May 12,2022 when I tried to OD. I have no memory of that day except vaguily coming to in the ER and rushed to Medical ICU. Angles were watching over me th[Show More]I have been in AA for 15 years clean and sober.After I got out of rehab my doctor wanted to try me on chantix to stop smoking. I never saw from the oustside with everyday emotions and dealing with the public that I sank into darkness until on May 12,2022 when I tried to OD. I have no memory of that day except vaguily coming to in the ER and rushed to Medical ICU. Angles were watching over me that day saying that my purpose on life was not finished yet and I truley beleve that.

  • NancyMay 28, 2011 at 1:47 am

    I started having blackout that I did not see coming, and on the 12th of made I bottomed out and tried to commit suicide and sudden blackouts , including an increased risk of suicides, suicide attempts.

  • KathieJanuary 23, 2010 at 11:19 pm

    I took Chantix for five days; the day I was supposed to increase dosage, I had an episode where my blood pressure dropped and I passed out and possible had some seizures. Needless to say, I stopped taking Chantix immediately and have had no reoccurence of the symptoms. Anybody else?

  • chabukaNovember 13, 2008 at 10:43 pm

    I quit taking Chantix after about three weeks..I was nauseated all the time...I have not picked up smoking again...but I am suffering from side affects fron the Chantix..high spiking BP (mine has alway been very low) (never had before) rapid pulse rate...kidney damage (doctor report)....weight gain..(upper body, weird) feelings of doom, depression, mood swings, lethargy, loss of libido, face, fee[Show More]I quit taking Chantix after about three weeks..I was nauseated all the time...I have not picked up smoking again...but I am suffering from side affects fron the Chantix..high spiking BP (mine has alway been very low) (never had before) rapid pulse rate...kidney damage (doctor report)....weight gain..(upper body, weird) feelings of doom, depression, mood swings, lethargy, loss of libido, face, feet and hand swelling (probably from the kidney damage) hot and cold flashes...constant headache, I would not recommend this drug... it doesn't seem to bother the men who have used it, as much as it has me..trying to find some way to flush it from my system....I know it should be out by now..but it sure doesn't feel like it......

  • HeatherNovember 12, 2008 at 11:59 pm

    I was taking Champix for three weeks last year in a bid to give up smoking, when one night I suffered sudden heart death. Luckily I am able to write this post and share this story because my husband was able to restart my heart after applying CPR for some thirty minutes. I was put on life support and was in the care of the hospital for sometime after. The doctors have ruled out a heart attack a[Show More]I was taking Champix for three weeks last year in a bid to give up smoking, when one night I suffered sudden heart death. Luckily I am able to write this post and share this story because my husband was able to restart my heart after applying CPR for some thirty minutes. I was put on life support and was in the care of the hospital for sometime after. The doctors have ruled out a heart attack although they recognise some damage to the heart tissues. No-one is able to tell me why it happened, however I am now fitted with a defibrulator to help prevent it happening again. It was reported 'apparently' that I was taking Champix at the time but no-one has ever asked me about it since. I would be interested to hear from anyone who has lost a loved one or survived a near miss as myself. It may be pure coincidence but I would like to know if it isn't. I am contactable on johncoupland@btinternet.com. regards Heather

  • MarciNovember 5, 2008 at 5:16 pm

    The first month was fine but THEN my legs started going numb. Now after 6 months and $4000.00 in medical bills trying to figure out what is wrong with me - I am feeling much better. I know it is because the Chantix is out of my system now. After several detox programs, long sweats and physical activity my legs, knees, back, neck, shoulder and feet are feeling better. The doctors would never say - [Show More]The first month was fine but THEN my legs started going numb. Now after 6 months and $4000.00 in medical bills trying to figure out what is wrong with me - I am feeling much better. I know it is because the Chantix is out of my system now. After several detox programs, long sweats and physical activity my legs, knees, back, neck, shoulder and feet are feeling better. The doctors would never say - it's because of the Chantix - even though I was completely healthy before taking it, other than being a smoker. I know it was the Chantix - there is no other explanation. Then after searching the internet and reading about others who have similar stories of numbness, burning, tingling, pain - horrible pain and the stress of thinking it will last forever - I know this evil product should be removed/recalled. No doctor who cares about his patients should ever recommend it. DON'T Try this evil product... by the way I started smoking again because of the stress of medical bills and I really thought I was going to die anyway - from the medical problems or by my own hand!

  • TaraOctober 31, 2008 at 2:32 pm

    I started Chantix May 30th, 2008 and now it's Halloween and I'm still not smoking. I owe every day of it to Chantix. After 2 months of taking it, I'll admit that the bizarre dreams became actually quite disturbing and I felt as though I could do without the pills from that point on. I filled the script but I never went to get them, and like I said, I'm still ok. The only other side effects I r[Show More]I started Chantix May 30th, 2008 and now it's Halloween and I'm still not smoking. I owe every day of it to Chantix. After 2 months of taking it, I'll admit that the bizarre dreams became actually quite disturbing and I felt as though I could do without the pills from that point on. I filled the script but I never went to get them, and like I said, I'm still ok. The only other side effects I recall was about 30 minutes after taking it I would become a little sick feeling for a couple minutes, other peoples smoke smelled absolutly nauseating and just being edgy but that comes with quitting. My boyfriend thought I was probably a little nastier than I should've been but I'll bet I'd be even worse off with cancer and side effects from that and chemo. It was my time to quit, so I did. Good luck to anyone who tries Chantix. If you can make it thru the side effects it really is worth the effort.

  • HollyOctober 25, 2008 at 3:04 am

    I have been taking Chantix now going into my 3rd week. So far the symptoms I have are Very vivid dreams, (which have been very entertaining), and one weird symptom; A little while after I take the medicine I feel a coolness, as in cold cool, rush from the back to the front of my head, as it may be spreading I guess, and I can taste it in my head before my throat. Thats it! Otherwise I think my moo[Show More]I have been taking Chantix now going into my 3rd week. So far the symptoms I have are Very vivid dreams, (which have been very entertaining), and one weird symptom; A little while after I take the medicine I feel a coolness, as in cold cool, rush from the back to the front of my head, as it may be spreading I guess, and I can taste it in my head before my throat. Thats it! Otherwise I think my moods are more from the withdrawl too, I've been hard to live with! But I can make it through the days a lot easier with the medicine than without it. I was told by my doctor to even inform my family to pay attention and notice any major differences in my personality, so far now just increased mood swings. And everyone knows that the need for food increases. I'm just careful about what and how often I eat, I know I'm high risk for diabetes.

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