Chantix problems were not fully reviewed before drug was approved

Before a new drug is sold, the manufacturer is supposed to establish that it is safe and effective through a series of clinical trials. However, in the case of the stop-smoking medication Chantix, problems which have recently linked the drug to reports of suicides and suicidal thoughts, were not fully researched by Pfizer before they introduced the drug. As a result, many smokers were not warned about the serious and potentially fatal Chantix side effects.

>>INFORMATION: Chantix Problems and Suicide

During clinical trials performed before the approval of Chantix, individuals with a psychiatric history or current psychiatric symptoms were not included in the studies. As a result, Chantix problems were not evaluated among people with common conditions such as depression, bipolar disorder and schizophrenia. However, many people with depression or other forms of psychiatric illness are smokers, and a large portion of the prescriptions for Chantix were made to people with these problems.

Depression, bipolar disorder, schizophrenia and other psychiatric symptoms are quite common among chronic smokers to whom the drug was aggressively marketed. In addition, there is a strong association between smoking and increased rates of depression and other psychiatric problems, yet the Chantix manufacturers chose not to evaluate the side effects their drug has on these people.

The glaring omission is particularly troubling since depression has been linked with increased addiction to nicotine and difficulty quitting smoking. Those who want to stop smoking and can do so easily, often do not require medical interventions to help them. Those who have repeated failed attempts at quitting are more likely to be vulnerable to the effects of nicotine and often have higher levels of depression.

Chantix works by targeting nicotine receptor sites in the brain, which should have given clear indication that the medication may have an effect on mood and behavior. Nicotine receptor sites are linked with the release of neurotransmitter dopamine, which is associated with a variety of psychiatric illnesses and treatments. The connection between dopamine and medical illness has been well established, and Pfizer should have understood the importance of including patients with depression problems in their clinical trials.

CHANTIX LAWSUITS FOR SUICIDE PROBLEMS

The lawyers at Saiontz, Kirk & Miles, P.A. represent individuals who are pursuing a Chantix lawsuit as a result of serious or fatal self-inflicted injuries which were caused by the medication. Chantix problems have been associated with an increased risk of suicides and erratic behavior. To determine if you, a friend or family member may be entitled to compensation, request a Chantix lawsuit evaluation.

8 Responses to:
“Chantix problems were not fully reviewed before drug was approved”

  1. Richard Says:

    started having side effects and stopped med on dr order. then withdrew still withdrawing. all of the side effects except cancer and death. still only on day 6 hope no permanent damage. lost work for me and roomate. had to be monitored. nov fda revied 55 suicides 199 suicidal thoughts homicide cant concentrate enough to this IS HELL.

  2. dreamscerulean Says:

    I went to a patient first in richmond and recieved a prescription for this… doctor never asked if I was bipolar or had any such problems and Im sure that they had it in my profile. Now reading some of the interaction stories and sitting here playing pro and con… I need to quit smoking but havent been able to go cold turkey or cut down, cant stand the habit and am disgusted at myself over it… Have been able to mostly keep myself stable without meds and dont know wheither or not to start taking the pills

  3. L Says:

    I took Chantix to quit smoking in February of 2007. It worked; I kicked a 30-year habit.
    The severe depression left after I stopped taking the drug (along with kidney pain).
    However, I developed chronic depression, the dark clouds that hang over each feeling, and it doesn’t go away. It subsides now and then, but it’s always there.
    Was it the Chantix that caused this? I can only assume so, since I was never this depressed for such a long period of time.
    I also found that I could not go back to smoking; the Chantix removed all pleasure from smoking.
    Know what you are doing before taking this drug.

  4. Cassie Says:

    Started taking Chantix in Dec. 2007. After 1 month of taking the meds myself and my family noticed a huge change in my behavior. I dropped out of school, started planning to divorce my husband, rarely left the house, and went from someone who never drank to one who drinks every night.

    Since I have realized these changes and their cause, I’ve been trying to overcome it, but haven’t had much luck. My Dr. suggested anti-depressants and therapy, but the thought of taking another drug doesn’t make feel to comfortable.

    Even though I have smoke-free for 5 months I can’t help but to think at what cost.

  5. JusticeB Says:

    I am Bi-Polar and started Chantix in March, 2008. My lung doctor warned me about the depression/suicide problems that were arising but because I always lean toward the manic side of things my family and I thought we would recognize problems as they might arise. Well, no one mentioned the extreme agitation and extreme mania that might come with Chantix messing with dopamines. By day 9, my marriage was on the rocks, I became violent, and extremely irritable, I was now unable to sleep and crying uncontrollably. By day 13, 92 consecutive hours with NO SLEEP AT ALL NOW, my family asks me to take one of my bi-polar meds that I had actually been off of since November, 2007 Seroquel to try to get some rest. At 1:00am I took a half of pill (50mg) and at 1:10am I had a grand mal seizure and completely stopped breathing. My husband began rescue breathing for about 1 to 1.5 minutes and saved my life. I was taken to the ER where I again had another grand mal seizure around 5:15am and then another small seizure around 7am. I don’t recommend that anyone take this medication without the proper information from Pfizer. My specialists, a psychiatrist, neurologist, and pulmonologist, were all unable to advise me as well as the pharmacy b/c all that was released was depression/suicide information

  6. Debbie Says:

    Im now confused!!! This is scarey as to the stories i just read on chantix.. Got any other suggestions on quitting?

  7. Katrina Says:

    Me and my husband started taking Chantix together in January 2008 after my womens doctor found a lump on my breast(which was nothing). We both have smoked for 20+ years and we was wanting to quiet anyway. I thought ,a mirical drug, by the way my doctor talked about it, what could go wrong?? About 2 weeks into the medican I started looking at my husband with hate and did not want him any where around me. I would have thoughts of killing HIM, not myself. I knew something was wrong and I just kept telling myself, I just am depressed about quieting smoking. One night he was watching TV, we had been on the meds for about a month and he heard about the law suits on the suicid. He came running down the stairs and told me and I quiet right then and there,and thought I will get better now. Boy was I wrong, I am still depressed I am on anti-depressants. I went on that med around May of 2008. When I stopped taking Chantix the wanting to kill my husband stopped but the depression staied. I went to my primary care doctor he told me this anti-depressant would help. I am better some days but I am scared I will never be MYSELF.
    My husband just broke down last night and told me he is still having suicidal thoughts and has for a long time but has kept it to himself and he quiet the Chantix the sametime I did. I wish there was help for us out there that trusted our Doctors to help us and the doctors was trusting the FDA. Who do we trust and who do we let help us. I know there is cases worse than ours and I am so very sorry to those people.

  8. mixed emotions Says:

    I am nurse and have spent a significant amount of time studying psychiatry and have been a smoker for 7 years. I would have to agree that with the amount of people that have quit smoking with little to no side effects from this medication that it is a miracle drug.

    On the topic of side effects…

    In practicing medicine I have found that ALL drugs have side effects for SOME people. If you have a side effect from a drug don’t take it. This quit smoking miracle pill may not be for you. It is the responsibility of the patient to report medication side effects and the responsibilty of the doctor to investigate a proper alternative. With medications that do cause side effects it comes down to a consequences vs. benefits debate. With some people with the suicidal thoughts it may be a debate of suicide vs. lung cancer or rather die now or later. You have the choice and they aren’t going to take a drug off the market becuase some people are experiencing extreme side effects.

    In the case of long lasting psychiatric conditions following the course of medication…

    Psychiatric conditions can often lay dormant in individuals who have never shown any sort of mental illness. Usually a tramatic event, reaching a certain age, or subtance abuse triggers the illness to show itself. The substance abuse, your age, nor the tramatic event CAUSED the problem. The problem has always been there, you just didn’t know about it. My speculation is that due to Chantix’s neurotransmitter involvement, that it is just another trigger of undetected mental illness in certain indiviuals. If taking Chantix has been the trigger for you, I strongly suggest you start therapy and see a psychiatrist so that you can handle the issue at hand.

    I don’t want to come off as insensitive. After all, I have major depressive disorder and know how haunting manic & suicidal episodes can be. Smoking is hugely associated with mental illness. So if you are having issues with this drug, stop taking it & see a psychiatrist. I have had great success with this drug, but I am also on an anti-depressant, so I haven’t had psych issues with it. Anyway, good luck to all of you.

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