...... alternative!
New Zyban Boxed Warning
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.
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And yet they want to ban the e-cig just in case it may be not 100% safe!
Thanks to VocaleK on ECF for the info.
Link to Vocalek's thread : -
www.e-cigarette-forum.com/forum/miscellaneous/34312-new-zyban-boxed-warning.html#post1261173
or a plastic pipe with ghastly tasting stuff in it ,,, gum ..... when we all know that when we need is something to do with our hands and the feeling of the smoke .....WE HAVE THIS HERE...NOW... it don't need development... it works ......... NOW YOU GOT ME ON A RANT ;LOL..... they stop us smoking there for they loose sales of tobacco products there for less tax money... they want to reduce the amount people drink there for sell less alcohol and get less tax......... the pubs are closing in there 100's less tax ........they want us to buy newer card that use less fuel less tax they have no idea what they are doing ... if i ran my company they way they run the country i would be bankrupt in a week ...OK RANT OVER hehe