New Zyban Boxed Warning

[Vocalek]

Received today from FDA Medwatch:

BOXED WARNING (updated)

• All patients being treated with Zyban should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking Zyban in the post-marketing experience. When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban.
• Advise patients and caregivers that the patient should stop taking Zyban and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of
  symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

WARNINGS

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment

• These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.
• When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban
• In many post-marketing cases, resolution of symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

PRECAUTIONS

Psychosis, Confusion, and Other Neuropsychiatric Phenomena

• In clinical trials with ZYBAN conducted in nondepressed smokers, the incidence of neuropsychiatric side effects was generally comparable to placebo. However, in the post-marketing experience, patients taking ZYBAN to quit smoking have reported similar types of neuropsychiatric symptoms to those reported by patients in the clinical trials of bupropion for depression.

Information for Patients/ Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation
Treatment

• Furthermore, some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide when attempting to quit smoking while taking Zyban.

MEDICATION GUIDE

• Changes throughout include text: "changes in behavior, hostility, agitation, depression"
• When you try to quit smoking, with or without Zyban, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.
• High blood pressure (hypertension): Some people get high blood pressure that can be
  severe, while taking Zyban. The chance of high blood pressure may be higher if you also use
  nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (see “Can
  Zyban be used at the same time as nicotine patches?”).
• Severe allergic reactions: Some people have severe allergic reactions to Zyban. Stop
  taking Zyban and call your doctor right away if you get a rash, itching, hives, fever,
  swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or
  tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.

 

[Dredbull]

I hate big pharma, prices for medicine is horrible.
Them not disclosing possible fatal and extreme side effects makes me very grrrr.

I had a script for zyban and let me tell you it was groovy, LOVED IT! Had a sucky job, a horrible home life/wife, but zyban made me happy. Until I was going through my routine main lining my coffee as normal and *BLAM* panic attack city! heart going like a race horse sweating up a flood...one of the side effects that was NOT on the package is sensitvity (under rated word, more like an interaction battle field of shock and wtf inside you.) to caffine. Stopped that crap RIGHT then and there, ok had to wait for it to clear out of my system and was a wreck for a about an hour.

Had a friend who was having all sorts of negative crap going on with the same product but as the generic, her problem was.. yep caffine. She cut it out and did really well.

 

[nebulizer]

I had a rx for zyban it put my head in the clouds,

 

[Chrissie]

And yet the FDA & other bodies want to ban the e-cig just in case it "may" not be 100% safe! What a joke - NOT!

Vocalek, I hope you don't mind that I've C&P'd your post in my own little forum? Just want as many people as possible to see this.

 

[Rico Suave]

Well, now I know why I have been depressed and confused for the last year....