Chantix Accidents and Black Outs May Lead to New FDA Warning
Published: October 24th, 2008 • Comments: 6
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.
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.
Comment by Holly on 24 October 2008:
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.
Comment by Tara on 31 October 2008:
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.
Comment by Marci on 5 November 2008:
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!
Comment by Heather on 12 November 2008:
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
Comment by chabuka on 13 November 2008:
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……
Comment by Kathie on 23 January 2010:
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?