FDA Mandates New Warnings For Prescription Smoking Cessation Drugs
On July 1, 2009, the Food and Drug Administration (“FDA”) issued an alert that requires manufacturers of several popular prescription smoking cessation drugs to add additional warnings to their products highlighting the risk of serious neuropsychiatric symptoms in persons using the drugs. The FDA also issued a Public Health Advisory to the public that these drugs have been associated with reports of changes in behavior such as hostility, agitation, depression and suicidal thoughts and actions, and that people who have had any of these serious symptoms should stop taking the medication and call their health care professional right away.
The drugs varenicline (which is marketed under the name Chantix) and bupropion (which is marketed under the name Zyban and is also marketed generically) are prescription drugs that have been prescribed to millions of people who wish to stop smoking. According to the FDA, some people who have taken these drugs have experienced serious and dangerous psychiatric side-effects, which include agitation, depression, hallucinations, mania, nightmares and psychosis. The most serious side-effect has been people having suicidal thoughts, and attempting to or actually committing suicide. Some people have reported having automobile and other accidents while taking the drugs, and other people have reported violent episodes associated with the drugs.
The reports of the psychiatric side-effects have mostly been in the “postmarket” period, meaning that the FDA has learned about the side-effects after the drugs were approved for use in the United States. The “postmarket” experiences with Chantix and Zyban led the FDA to issue new requirements that these drugs have “Boxed Warnings” to alert consumers about the serious psychiatric side-effects that have been documented, and also led the FDA to warn the public about the side-effects.
Stopping smoking is a positive thing, but consumers should be cautious about the medications that they use to help quit smoking. If you or someone you know has experienced serious psychiatric side-effects that you believe are associated with Chantix or Zyban, please contact us to discuss your legal options.
30Jan2012. My brain was so receptive to Zyban that within 3 days I had completely stopped smoking never to smoke again. I had also lost interest in wine and chocolate.... No side effects so speak of. So far so good.. but at the end of my treatment (2 months) I had a violent rage episode and went on a rampage. Permanent memory loss of 20 minutes of this episode. 6 years later, I am still a zombie, no interest in life, no short term memory, no attention span, no concentration,mood swings. I found a few postings of people still suffering side effets years later, like me, from using this very dangerous drug. Anyone else?
My husband was prescribed Bupropion to help him quit smoking. He felt it was helping because he cut back to ten ciggs a day. Please be carefull if you take this drug. I had no idea that he was feeling suicidal. I wouldn't want anyone to go through what my family has gone through.
My husband committed suicide on 6/3/09 while taking Bupropion to help him quit. This is a very dangerous drug. Mu husband was not a suicidal person. He did cut way back on smoking which is why he continued to take this drug. I would not want anyone to go through this hell. Be careful on this drug. I think it should be taken off the market.
I've tried just about every method there is out there and there is only one I can recommend - NLP! It eliminates the cravings.
Gum patches and all the other just did not cut it for me, not to mention cold turkey which was the hardest, I even tried the electric cig and it is just no match to the real thing.
Check out this article: http://quit-smoking-today.bestof-the-net.com/
it’s the one that got me off the cigs and smoke free for GOOD even without gaining weight! :)
Good luck kicking the habit!
J.
My husband passed away on New Years Eve--looks like some kind of heart failure but I haven't yet received a diagnosis from the coroner. He started taking Chantix about a month before.