Chantix Side Effects Examined by FDA for Skin Reactions and Accidents

The anti-smoking drug Chantix, which was previously linked to an increased risk of suicide and suicidal behavior, was listed on a report released Thursday by the FDA of medications they are currently investigating for potential signals of new serious risks.

Chantix (varenicline tartrate) is one of 19 drugs or classes of medications identified by the FDA that showed potential signs of safety issues in the Adverse Event Reporting System (AERS) between October 2008 and December 2008.

Side effects of Chantix are being examined for a possible increased risk of angiodema, serious skin reactions, visual impairment and accidental injury. The FDA indicates that they are evaluating these issues to determine whether there is any need for regulatory action, such as stronger warnings.

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Chantix, which is manufactured by Pfizer, was approved by the FDA in May 2006 and quickly showed signs of becoming a potential blockbuster medication. Early last year, sales slowed substantially after Chantix side effects were linked to a high number of suicides, suicide attempts and other reports of unusual aggressive behavior.

A number of Chantix lawsuits have been filed in state and federal courts throughout the United States alleging that Pfizer failed to adequately research or warn about the psychiatric effect the drug has on the brain. Last year, Pfizer updated the warnings about potential Chantix suicide problems several times after the FDA began investigating adverse event reports.

The potential safety issues identified by the FDA this week focus on a different set of potential health concerns.

According to the FDA statement, there have been reports of angiodema from Chantix, which is a rapid swelling that occurs beneath the skin, as opposed to on the surface. The swelling can develop very quickly, and can pose a medical emergency as airway obstruction and suffocation can occur.

The FDA also indicates that other serious skin reactions have been reported, which likely include reports of Stevens-Johnson syndrome from Chantix. Stevens-Johnson syndrome is a condition where the skin burns from the inside out, which can be caused by several different medications. It is a life-threatening condition that can lead to disfigurement, blindness and organ failure.

The Chantix Stevens-Johnson syndrome problems first surfaced in an independent report from the Institute for Safe Medicine Practices early last year. That same report also identified a potential increased risk of accidents on Chantix, which the FDA now indicates they are reviewing.

The FDA has received a number of reports of serious accidents and falls among users of Chantix, which could impact an individual’s alertness or motor control. In response to the Chantix accident problems, last May the Federal Aviation Administration (FAA) issued a Chantix ban for all pilots and air traffic controllers and the Federal Motor Carrier Safety Administration (FMCSA) indicated that those taking the drug should not qualify for a commercial motor vehicle license.

Although the FDA indicates that they are investigating these potential safety issues, it does not mean that they have concluded that there is a causal relationship between Chantix side effects and the risk identified. The FDA indicates that they are continuing to evaluate these potential Chantix problems to determine whether any steps need to be taken to protect the public.

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7 Comments

  • CatherineJune 28, 2019 at 5:00 am

    Maxine, I hope you see this. I have had chronic hives for about 10 years and took chantix prior. What regiment were you put on to control your hives and reverse your other symptoms? I too have had joint pain, weight gain, itching and sores on my scalp as well.

  • JessicaJanuary 20, 2018 at 6:28 pm

    I have been on chantix for 18 days not. Yesterday and today I have started having rectum bleeding. I also have been having bad dreams and restlessness where I feel like I never really sleep. I have put a call into my doctor and am waiting if I should stop this drug.

  • MacinleyMarch 10, 2015 at 6:30 pm

    I only took a half of the whole pill. I'm sick to my stomach. Very very itchy. Severe headache. Chest pain. Back pain. Anxiety has went old the walls. Feel like I'm losing my balance. And it's my first day.

  • MaxineJuly 8, 2010 at 5:54 pm

    I quit taking chantix after 2 months when the side effects became to bad to continue. That was 2 years ago. I no longer have the severe gastritis, but have had issues with same. I have had chronic urticaria (hives) for the entire 2 years, along with joint pain, excessive weight gain, abdominal pain, rectal bleeding, severe itching and sores on my scalp, thyroid problems, and as a result of thos[Show More]I quit taking chantix after 2 months when the side effects became to bad to continue. That was 2 years ago. I no longer have the severe gastritis, but have had issues with same. I have had chronic urticaria (hives) for the entire 2 years, along with joint pain, excessive weight gain, abdominal pain, rectal bleeding, severe itching and sores on my scalp, thyroid problems, and as a result of those and other problems, I have been just too tired of being sick and tired. After seeing a specialist for the hives and 2 years worth of all kinds of medication, I think he may have them under control. When I mention other symptoms to other Doctor's and express my concern about how they may be related to Chantix. I get the deer in the headlight look. In other words they think I'm neurotic. After a recent ER visit for Severe abdominal pain and rectal bleeding, I was diagnosed with infectious colitis. Then after 10 days of antibiotics I started feeling better than I had in a long time. A month later I came down with bronchitis--another 10 days of a simular antibiotic. I have not taken an antibiotic in the last 2 years. The sores on my scalp have gone away, the itching has stopped, no more gastrointestinal problems so far, I am losing weight, my metabolism has sped up, my joints don't ache. I don't know what has been wrong, but I feel like I have gained 20 years back. I didn't realize how bad I was feeling until I began feeling like my old self. I have 5 more days on the antibiotic and it is my greatest hope to continue to recover. I hope posting this can help someone else. I hope by posting this it may help someone else. When I mention other

  • johnJune 29, 2010 at 1:19 pm

    i had a heart attach in 07 the heart doctor told me to quit smoking so i toke chantix for 2 week and almost kill meself by hanging now doctor say there nothing wrong had a stoke i woke up in the hos. i think they have to found what part of the brain it is shuting down and repair it the had to be aprove fda i hold them the blame for all this test is the law for drugs to be marked fda aproven them

  • EugeniaJune 6, 2009 at 5:16 am

    I've been hiding in my apartment and lying about my condition to friends and family. I don't feel suicidal. I feel afraid to be around people. I suddenly want to end relationships that I enjoyed before starting this medication. I've not had a decent night's rest. Dreams of people's heads being cut off and such. I'm exhausted. Started seeing rats and such yesterday. Stopping the drug as of t[Show More]I've been hiding in my apartment and lying about my condition to friends and family. I don't feel suicidal. I feel afraid to be around people. I suddenly want to end relationships that I enjoyed before starting this medication. I've not had a decent night's rest. Dreams of people's heads being cut off and such. I'm exhausted. Started seeing rats and such yesterday. Stopping the drug as of today. Am I the only one?

  • GordonJune 5, 2009 at 10:25 pm

    Chantix, put me in the hospital for 4 weeks.I was in a coma for 2 weeks out of the 4 and almost died on the 8th day.The Doctors did'nt think I would recover from the coma. My Admitting Diagnosis was:Confusion/mental status Acute renal failure.Leukocytosis. Final Diagnosis was:Acute renal failure secondary to acute tubular necrosis.Renal oxalosis,showing on kidney biopsy.Cardiac arrhythmia with [Show More]Chantix, put me in the hospital for 4 weeks.I was in a coma for 2 weeks out of the 4 and almost died on the 8th day.The Doctors did'nt think I would recover from the coma. My Admitting Diagnosis was:Confusion/mental status Acute renal failure.Leukocytosis. Final Diagnosis was:Acute renal failure secondary to acute tubular necrosis.Renal oxalosis,showing on kidney biopsy.Cardiac arrhythmia with sinus pause.Status post extubation and ventilator-dependent respiratory failure. and so on.I had to much to list here.But,this drug almost killed me.I have never been in any hostiptal for anything.This was a nightmare and a painful problem for me.

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