Chantix Recall Should Be Considered by FDA
A recent report by the Institute for Safe Medication Practices (ISMP) indicates that side effects of Chantix continue to account for a large number of the serious psychiatric problems reported to the FDA, despite a “black box” warning added to the label and a medication guide that is given to every patient. That should be a sign that the medication needs even more restrictions or other regulatory action, such as a Chantix recall.
>>MORE INFORMATION: Chantix Suicide Side Effects
On this blog, we have been calling for a recall of Chantix for a long time due to the increased risk of suicide, suicide attempt, hostility, aggression, depression and psychosis. In addition, prior studies have suggested that the drug may be no better than other treatment options to help people stop smoking.
Last month, the Institute for Safe Medication Practices (ISMP) released a report (PDF) on adverse drug side effects reported to the FDA in the second-quarter of 2010.
Chantix has now caused more than 8,500 reports involving serious injuries, with a steady stream that exceeds most other prescription medications. According to the report, in the second quarter of 2010 alone there were 130 possible cases of Chantix clinical depression, 112 possible cases of hostility-aggression from Chantix and 70 cases of Chantix psychosis and reports by people who say the drug made them lose touch with reality.
ISMP indicated that these case reports continue to exceed the number reported with the most powerful antipsychotic and antidepressant medications, which are used in much more vulnerable groups of patients with mental disorders.
After observing that these Chantix problems continue to be reported, despite the FDA having deployed most of its regulatory tools short of a Chantix recall, ISMP concluded:
The evidence shows that the numerous regulatory actions from the FDA and other restrictions have not succeeded in achieving substantially safer use of (Chantix) varenicline beyond a possible effect in reducing dispensed prescriptions. A major reassessment of this drug’s place, if any, in a program of treatment to assist in smoking cessation is needed.
CHANTIX RECALL LAWSUITS
The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix suicide lawsuit or other injury claim from the medication. Despite information that should have led the drug maker to recall Chantix long ago, the medication has been marketed as a safe method of helping people quit smoking.
If you, a friend or family member have suffered a serious injury or death from Chantix, compensation may be available through an individual Chantix lawsuit. To review a potential claim, request a free consultation and case evaluation.
…YANK IT!!!…
I lost my husband last December. He was taking Chantix! It needs to be pulled off the market. It is poisen
….YANK IT!!!!!!!!!!!!!!!!!!!!
TAKE THIS CRAP OFF THE MARKET!! My husband tried to take his own life while taking Chantix… It needs to be band!!
Chantix is the only thing I have found in my many attempts to quit smoking that has actually worked. I have had no adverse side affects other than maybe strange dreams. The benefits of stopping smoking I feel strongly out weigh the side affects.
living in hell right now because of chantix take it off the market,pay those whos lives have been destroyed by it because monies is the only compensation they can offer to make up for taking my life away.unless the make a wonder pill to reverse the effects of chantix.
I had the most horrible experience of my life and feel that I may never truely recover. I have been under psychiatric care since 2007 because of Chantix. This was the biggest mistake I have ever made in my entire life and there is no turning back. I suffer from anxiety, depression, and post traumatic stress. A routine physical from an internal med doctor who used me as a guinea pig for Chantix is walking around normal while I am messed up, nice!
I agree with Holly except my doctor had all my records for 20 years. He turned his back on me when chantix changed me and not for the better either. I know it was not quitting smoking since I did that cold turkey later. It is about time someone who has the authority uses it instead of ignores. I hope the guy the FDA had answering complaints in 2007 who told me “no one put a gun to your head and made you use it” knows how wrong he was now that his brain is no longer under the influence of chantix!
I was just at the doctors office and they highly recomened it. Are they getting a cut for pushing this. I have seen that happen on tv. I want to quit but after reading all this I’m afraid to spend the money on it. And I don’t need to be depressed or try to off myself. What should I do?
the only SAFE way to TAKE Chantix…is to NOT SWALLOW!
I take chantix and it is working for me..the only problem I have is the nausea. but that is a side effect of it. When you stop and think about it, quit smoking will cause the depression, anxiety, and mood changes…I recommend it to stop smoking. I have smoked for 37 yrs and close to a 2 packs a day, now since I started it, a pack of cigarettes has lasted me 3 days. And that is something.
I am a 51 year old female. I have been on and off Chantix for several years, to this day, I cannot of my own free will seem to stop taking the medication. The company claims it is non addictive yet I beg to differ. I have noticed a change in my ability to sleep through the night, freakish nightmares, bouts with depression both on and off the medication, aggression, agitation and nausea. I had a 2 year success in staying smoke free,but only after taking the first 3 month prescription several years ago when the drug was first approved by the FDA. My husband was successful at quitting on Chantix as we both started the process at the same time, he remains cigarette free but does occasionally smokes a cigar. We both agree that during the time on Chantix we would both experience overwhelming craving feelings,so overwhelming that it became a topic for discussion on many occasions. We never could figure out what it was that we were craving and it absolutely was not cigarettes. Since then I have bounced back and forth with a few months at a time of being smoke free only after taking Chantix time and time again. After finally doing some research on the side effects of the medication I am convinced that Chantix has aided if not been completely responsible for my current ailments. I have recently gone to my doctor and requested an anti depression medication called Wellbutrin,I want to note that I have no valid reason for my bouts with depression they come and go without warning. My life is not stressful nor have I ever been one to dwell on things we cannot change. I do know that I have not previously experienced anything like this prior to my exposure to Chantix. I am hoping that I will be able to stop taking the Chantix as well as quit smoking. Wellburtin has been known to be successful in both treating depression and stopping smoking. Failing this I am at a loss as to what to do at this point.I realize now that in trying to resolve one addiction I have acquired another. Please be warned if you are considering taking this drug. Although you may not experience any side effects at first realize that mine started almost 2 years after taking the drug and I continue all these years later to attempt to find a way to get off both the Chantix and the cigarettes.