Champix was launched in a blaze of media glory in 2007 claiming that 44% of people would stop smoking while taking the drug, however the actual success rate was much lower at 22% but serious side-effects have come to light including, suicides, violent mood swings and patients suffering from sever depression, in addition the FAA -Fedrel Aviation Autority have banned ALL pilots, private and commercial for flying if they take the drug.

Champix pills are not as successful as claimed and have been on sale since September 2006. As with Zyban they have some serious and unpleasant side effects. The UK Government's medicine watchdog, the Medicines and Healthcare products Regulatory Agency, had received 3,541 reports of patents suffering serious side effects, including ten suicides.

The drug, launched in the UK in 2007, was also linked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders. The US Food and Drug Administration began investigating the drug, called Chantix in the US, in November after it reported 55 cases of suicide and 199 cases of suicidal thoughts in just one week.

Pfizer, who make the smoking cessation drug Chantix (varenicline), have updated the drug's labelling in the United States to reflect the fact patients may experience "serious neuropsychiatric symptoms", including suicidal behaviour.

Two years later in 2009 the U.S. Food and Drug Administration said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of Champix due to reports of behavioral changes, depressed mood , agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA's adverse event reporting system.

Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in buproprion users, the agency reported.

There are also 165 potential side-effects listed on Pfizer's "Full Prescribing Information" sheet. Although Pfizer's Patient Information sheet mentions vomiting, nausea, abnormal dreams, sleep disturbance, and constipation, it fails to alert smokers to less frequent yet more serious risks such as kidney failure, suicidal thoughts, hallucinations, psychotic events, joint pain, muscle pain, arthritis and suicide.

There are 165 side effects associated to taking champix so it is important for you to know. The most common side-effect is nausea, other side effects include:

• Headache
• Difficulty sleeping (insomnia)
• Abnormal dreams
• Sleepiness
• Dizziness
• Change in taste
• Dry mouth
• Disturbances of the gut such as constipation, diarrhoea, vomiting, abdominal discomfort, indigestion, flatulence
• Changes in appetite
• Airway infections
• Mood swings
• Changes in sex drive
• Tremor
• Restlessness
• Awareness of your heart beat (palpitations)
• Skin reactions such as rash or itching
• Increased urination
• Chest pain
• Increased blood pressure

Some people found that after they stopped taking Champix:

• the urge to smoke returned, as with NRT
• they felt irritable
• they felt depressed
• they had sleeping difficulties.
• As with Zyban, Champix must be used in combination with motivational support techniques.
• There are also some people who aren't suitable for this type of treatment.

In addition over 1,000 hardened smokers were denied access to the trials while those who did participate also received 16 counselling sessions and a course of NRT following the 12 week use of champix which then achieved the claimed 22% (1 in 5) success rate. Critics state the full facts have not being disclosed and the success rates have been exaggerated to boost public confidence and increase poor sales.

Champix Facts:

On September 29, 2006, Pfizer issued a press release announcing European Commission approval of Champix, its new quit smoking pill. It boasts that "after one year, approximately one-in-five patients (20%) who received the 12-week course of varenicline [Champix] remained smoke-free." This is now very different to the information published in the media and presented to NICE in the UK for NHS approval.

What we do not know is whether Champix's modest 1 in 5 success rate is attributable to the effects of Champix or to the 16 clinical counseling sessions participants received or to the use of nicotine replacement therapy (NRT) following 12 weeks of Champix use, or to the fact that more than 1,000 hard to treat smokers were denied participation. What we do know is that Pfizer's clinical Champix studies were not blind as claimed.

Understandably, Pfizer wants to assign full credit for the results from its five varenicline studies to Champix. Understandably, it wants smokers to believe that, as in its clinical studies, 1 in 5 who purchase Champix will succeed. But if cessation pharmacology history teaches any lesson it is that clinical studies are engineered for victory, and unless real-world users can find a way to duplicate study engineering they should expect to experience dramatically lower success rates.

Champix in the Media:

Champix anti-smoking drug linked to 10 British suicides

Health chiefs have revealed that ten people have committed suicide after taking a controversial anti-smoking drug linked to depression. The disclosure by the Government's drugs watchdog is the first time officials have revealed the link between Champix and suicide in this country. Earlier this year, US authorities announced they were investigating 37 similar cases there.

The Medicines and Healthcare products Regulatory Agency (MHRA) website says a total of 24 people taking the nicotine-replacement have died, of whom ten took their own lives. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.

There is no evidence that Champix has been a factor in any of the deaths. However, some experts are concerned that the drug, used by almost half a million people in Britain, may cause depressive thoughts and mood swings. The MHRA says the number of users reporting adverse side effects while using Champix, also known by its generic name varenicline, has doubled in the past seven months – up from 1,811 in February to 3,541 in September.

The figures are on the MHRA's website, which holds regularly updated information about the reported effects of drugs licensed for use in the UK. The information is provided by doctors, nurses and patients. The watchdog is now warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.

Its latest bulletin states: 'We continue to receive reports of suspected adverse reactions associated with varenicline, the most frequently reported of which are psychiatric disorders. As Christmas and the time for New Year's resolutions approach, we remind you to highlight to those taking varenicline the possibility of adverse psychiatric effects.'

Last April an inquest heard how TV producer Omer Jama, 39, slashed his wrists eight weeks after starting a course of pills. A toxicologist told the hearing: ‘There is a possibility he could have been influenced by the side-effects of the drug.' In November 2007, father of two Wayne Marshall, 36, from Doncaster, was found hanged shortly after completing a 13-week course of Champix.

Karen McGhee, 38, from Greenock in Scotland, tried to hang herself following a course of the drug. She said: ‘I don't have any doubt Champix is what caused me to try to take my own life.' Bob Rappaport, of the US Food and Drug Administration's drug-evaluation centre, has said: ‘A number of compelling cases look like they are the result of exposure to the drug itself and not other causes.'

Earlier this year all pilots and air traffic controllers in the US were banned from taking the drug because of fears about potential side effects. Champix was launched in the UK in 2006. It works on the brain's receptors to reduce the cravings and withdrawal symptoms associated with quitting. In trials, nearly a quarter of those taking Champix had given up smoking after a year compared with 16 per cent using nicotine patches.

But after monitoring adverse effects, the European Medicines Agency ruled last December that the safety leaflets in boxes of Champix be updated to include warnings about suicide and depression. Manufacturer Pfizer added the warnings in February and updated them in July. It advises patients who suspect they are experiencing side effects to stop taking the medication.

Pfizer said: ‘Stopping smoking, with or without treatment, is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. ‘Pfizer rigorously tested varenicline in a comprehensive clinical trial programme lasting many years and involving thousands of patients. ‘Based on the results of those clinical trials, regulatory agencies in Europe, the US and elsewhere have recognised the safety and efficacy profile of varenicline and approved the medicine for use in smoking cessation in adults.' 10.11.0

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Stop smoking drug 'Champix' concerns raised

It was launched as a wonder drug. A tablet to take the pain out of kicking the killer weed. Since it appeared on the market two years ago in the UK , almost 400,000 prescriptions for Champix have been written. Across the world, that figure is currently sitting at nine million. Champix, or varenicline, to give it its clinical name, was first licensed here in December 2006.

It mimics the effects of nicotine on the body so it both reduces the urge to smoke and relieves withdrawal symptoms. In clinical trials, it proved more effective than alternative remedies at getting people to quit. For its makers - Pfizer - Champix has been a huge success.

In its first full year on the market, the drug brought in a staggering $883m for the company. But about a year ago, I became aware of stories emerging in the media in which people who had taken Champix were said to have suffered severe depression. I learned of a woman, Karen McGhee, from Greenock , who tried to kill herself just a few days after taking Champix. Her husband Robert told me of the night he found his wife hanging from the hall stairs.

Robert McGhee said: "I just got woken up with my daughter dragging me out of my bed to come downstairs. She was shouting, 'Dad, my mum's hung herself. She's hung herself'. And I just couldn't comprehend it, I thought I was dreaming.

"I ran downstairs and Karen was on the floor on her knees with a pelmet round her neck. I tried to lift her up to free the knot, but I couldn't get it loosened. I managed to cut her free and take the noose off her neck."

'Suicidal tendencies'
After several days on a ventilator, Karen McGhee pulled through. She is convinced it was Champix which led to her suicide attempt. She said: "I'll never put myself through that again and never put my family through it again. I'll always be a smoker, or, if I quit, then I'll quit naturally."

I heard of another case - Omer Jama - a young Manchester man who had killed himself while taking Champix. His brother, Ali, said: "He'd slashed his wrists. They'd found him on the floor in the landing and it was a shocking scene. There was no suicide note. It was just a random act, completely out of character, that took an instant." Omer had clearly taken his own life. But surprisingly, at the inquest, the coroner did not record his death as suicide.

Ali said: "The coroner recorded an open verdict because she couldn't record a verdict of suicide, because on the evidence of the forensic toxicologist she found that Champix was still in Omer's bloodstream and she had researched that it had possible links to suicidal tendencies. So she couldn't rule out that it didn't play a part in his suicide."

I discovered that across Britain , more than 3,000 people have complained about adverse reactions to Champix. About 260 have reported suicidal-related reactions to the drug. Of these, 16 had attempted suicide and 10 had killed themselves. But 260 reported bad reactions, no matter how severe, sounds like a drop in the ocean compared to millions of Champix prescriptions. I wanted to know whether these extreme reactions were just isolated cases.

I went to the US where the drug - marketed there as Chantix - was developed and first launched. I met James Elliott, a veteran of the war in Iraq , who had been given the drug by the US Government's department of Veterans Affairs, as part of his treatment for post-traumatic stress disorder. One night, a few days into the Chantix course, he fought with his girlfriend, grabbed a handgun, walked into the Washington DC night, and forced the police into an armed stand-off.

James told me: "I think there were nine officers there. And two of them had rifles trained on my head. Those guys would not have missed. I antagonised them. You guys got guns. You tough guys. Shoot me. It'll be alright." The police used a taser gun to subdue him, and he's lucky to be alive today.

'Psychiatric problems'
His story prompted an investigation by the US Congress. Giving evidence, he told them he was never warned about the possible side effects. He is adamant Chantix played a part in his actions that night. He said: "I put the whole community at risk. I did. The doctors did. Chantix did."

During my investigation, I also met one of the country's leading personal injury lawyers. Marc Grossman has launched five law suits against Pfizer and has 20 more cases ready to go. He said: "We have a 40-year-old man with three children who has no prior history of psychiatric problems who, out of the blue, went and put a shotgun to his mouth and killed himself. "And another case is of a man who shot himself in the head. "We have a woman with kids who hung herself. "All the cases are just the most shocking, bizarre scenarios where someone just out of the blue commits suicide without any prior depression."

I suggested to him that it wasn't unusual for people to commit suicide out of the blue with no history of depression. He told me: "It doesn't happen as often as with the people taking Champix. It happens far more often that you'd ever expect and far more often than is acceptable."

Champix is big business, but it is also designed to be the answer to one of the most serious health issues facing the world, and especially Scotland . Here, 13,000 people die every year from smoking-related illnesses, and it's the single biggest preventable cause of death. Against that backdrop a drug which stops people smoking would be welcomed, and even a small decrease in smokers would loosen up resources across the Scottish health service.

Pfizer declined to speak to the programme, but a statement from the company said the packs carry warnings about the reported side effects, and point out that there's no proof the drug has any links with suicidal behaviour. The body which licenses pharmaceuticals for use across the whole of the European Union tells us it's monitoring the drug closely, but at the moment feels the benefits of Champix far outweigh any current potential risks.

Monitoring programme
Dr Hans-Georg Eichler, senior medical officer with the European Medicines Agency (EMEA), told me: "This drug is designed and has been shown to be effective in helping patients quit smoking. "Now we all know that there are several hundred thousand premature deaths across the European Union every year. "This is a major public health issue. We know that a large proportion of smokers want to quit but they find it difficult.

"So against that background any drug, and I emphasise any drug, that has a positive benefit risk profile is valuable and welcome. "I think the public is justified to be concerned and we're extremely concerned. "But being concerned is not the same as being convinced that there is a causal relationship. "So that's why we have implemented a high alert monitoring programme.

"We have here in the agency weekly meetings where we would analyse all the incoming data, and would alert the committee that is relevant, the working party, that is charged to specifically look at these events and see what action is required.' 26.11.08

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Woman tries to kill herself while taking Champix: Is this smoking pill safe?

When Karen McGhee woke up in a hospital bed and saw her teenage daughter looking anxiously at her, she was completely flummoxed. "My arm was bandaged and the left side of my mouth and neck felt numb, as if I had been to the dentist - but I had no idea why I was in hospital," says the 38-year-old.

"Then Jenna told me I'd tried to kill myself. She said her nine-year-old sister, Aynslie, had found me in the middle of the night hanging from the banisters with the pelmet from the curtains tied around my neck." Karen listened in horror as her daughter recalled how she had turned blue through lack of oxygen, and her heart stopped five times in the ambulance on the way to hospital. The doctors were convinced Karen had brain damage, and after three agonising days her family had decided to turn off her life support machine. She was expected to die within minutes, but instead miraculously began to breathe on her own. With absolutely no memory at all of what she'd done, Karen says her daughter's account of what had happened was like hearing about another person. "My last recollection was of being extremely happy," she says.

In fact, the mother-of-three from Greenock , Scotland , had developed severe depression and tried to hang herself after taking Champix - a pill designed to help reduce nicotine withdrawal symptoms and stop cravings. Yesterday, the Mail reported how Wayne Marshall, a 36-year-old father-of-two from Doncaster , was found hanged shortly after completing a 13-week course of the same drug. Last October, TV editor Omer Jama, 39, committed suicide after starting using Champix.

Medical watchdogs are being urged to investigate the drug to ensure it is safe to use. The drug works by binding to nicotine receptors in the brain. Nicotine stimulates the production of dopamine, which is the "pleasure" chemical in the brain. By attaching itself to the receptors normally used by nicotine, Champix fools the brain into thinking it's had nicotine - so satisying the craving for a cigarette.

The drug has modest success rate. After 12 weeks, 22 per cent of those taking Champix have given up smoking. However, since the drug's launch in Britain in December 2006, the Government's drug safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has received 1,513 reports of adverse reactions, including 62 reports of suicidal feelings.

As Jenna told her mother what had happened, Karen began to wonder if the medication she'd been taking in the weeks up to the fateful event had played a part in it. "After Robert's heart attack last July, his consultant recommended Champix to him," she says. "He smoked 60 a day and had never been able to quit. "I decided I would also try to quit my 20-a-day habit. My husband's heart attack had hammered home to me just how dangerous smoking can be."

The couple were given a standard 12-week course of Champix tablets and told to try to give up cigarettes ten days into the course. However, just days after starting on Champix, Karen realised something wasn't quite right. "I started to feel really grouchy all the time, and would shout and scream at my family for no good reason, which is totally out of character."

Indeed, she became so moody that even her mother-in-law noticed something was wrong and suggested she should stop taking the pills. But Karen thought it was probably nicotine withdrawal that was causing the problem - and so continued. However, she began to feel even worse. "I started being sick about three times a day," says Karen. "Looking back, I was stupid to think it was because I'd quit smoking, but I'd had no idea what to expect.

"I also became really depressed. I felt so low that I couldn't see the point in doing anything. Normally, I am an active person, but I started spending the whole day slumped on the sofa. I had no enthusiasm for anything." Karen had suffered from mild depression on and off for the past 20 years and started taking antidepressants in 2005. However, she says Champix made her feel lower than ever.

In September, just under two months after she'd started taking the drug, her husband became very concerned. "Robert said he wanted his wife back - and pleaded with me to stop taking the tablets," says Karen. He was so worried by the effect the pills were having on his wife that he had stopped taking them himself. He had also become irritable. Despite this, Karen was still convinced the pills were not the problem, and put her symptoms down to nicotine withdrawal. "I was so low that my mother said to me: 'I would rather you started smoking again than continue like this'." she says.

"Robert kept trying to do things to cheer me up, such as taking me out for dinner, but I could not shift this deep depression. I did not bother talking to my GP about it because I thought it was just something I had to endure after giving up smoking."

On October 17, following a meal out, the family went to bed as normal. The next thing that Karen remembers is waking up in hospital. The following day a psychiatrist came to see her. Karen says: "Robert showed him the Champix and said : 'Do you think this made her do what she did?' The psychiatrist said: 'It won't have helped'." Karen stopped taking the pills immediately. She was kept in hospital for a week, where her mood improved drastically. Her husband said he felt as if the "old" Karen had come back.

She now has a six-inch scar on her arm where it was burnt on the radiator during her suicide bid. But the mental scars are much deeper. Her daughter Aynslie is so traumatised by what happened that she refuses to go up the stairs alone. "I try each day to be as nice to my children as possible, to make up for what I put them through," says Karen.

"Aynslie said to me recently: 'Don't feel guilty about what happened, Mummy. It wasn't you - it was the pills'. "I am convinced Champix is to blame for what happened to me. "A week after my suicide bid, I opened the paper to read about Wayne Marshall, who did kill himself after taking Champix.

"It sent chills though me. It could so easily have been me, and the idea of leaving Robert and the children is just unthinkable. "I am ashamed to say that a week after leaving hospital, I started smoking again. No one has criticised me for it. They would all rather have me smoking than dead. "I suspect I will smoke for the rest of my life. After everything that has happened, I am just too frightened to give up."

Dr Alex Bobak, a GP from Wandsworth, is the only doctor in the country to have a specialist interest in smoking cessation and has helped conduct trials on Champix (though he is not paid by the makers). He believes the drug is safe. "I am convinced it is giving up smoking, and not the effects of Champix, which have caused some people to feel suicidal," he says.

"Without nicotine, many people do become irritable, grouchy and depressed - even suicidal. "This is because nicotine stimulates the production of dopamine in the brain, a chemical which induces feelings of happiness. Without it, some people can become down. "Interestingly, in trials on people trying to quit smoking, those taking Champix reported feeling much less irritable and depressed than those taking a placebo pill.

"I think that for most people Champix does help reduce all the bad feelings, but for some people - and I believe only a small minority - it does not do this enough. "I would urge people not to be put off taking this drug. Remember, more than 50 per cent of long-term smokers will die prematurely as a result of a smoking related disease."

Pfizer, the makers of Champix, said in a statement: "We are working closely with the EMEA ( European Medicines Agency) to review reports of depression and suicidal thoughts in patients attempting to stop smoking and taking Champix. "There is no scientific evidence establishing a casual relationship between varenicline (Champix) and these reported events."

However, Pfizer, who make the smoking cessation drug Champix (varenicline), have updated the drug's labelling in the United States to reflect the fact patients may experience "serious neuropsychiatric symptoms", including suicidal behaviour. 23.1.08

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Widow claims father-of-two driven to suicide by 'quit smoking' drug champix

A widow claimed yesterday that a drug designed to help smokers quit may have played a role in her husband's suicide. Father-of-two Wayne Marshall, 36, was found hanged shortly after completing a 13-week course of Champix, which it is feared may have depressive side effects. His death is the second in the UK to be linked to the newly-licensed drug.

Mr Marshall's widow Emma said he was prescribed the drug by his GP last August to help him quit his 20-a-day habit, but quickly went downhill, cutting himself off from his family and friends. Mr Marshall, a welder, from Rossington near Doncaster, died in November. Last month, an inquest in Doncaster recorded a verdict that he killed himself.

Mrs Marshall, 28, said she believed the drug had played a part in his death and has reported the case to the Medicines and Healthcare Products Regulatory Agency. "I don't want anybody to go through what myself, his children and his family and friends are facing," she said. "It is horrendous. "People need to think about going on this drug, particularly if they have a history of depression.'

After her husband's inquest, Mrs Marshall, a distribution coordinator, discovered Champix has been linked to depression. Mrs Marshall, who said her husband had once before attempted suicide when he was a teenager, had moved out of the couple's home a month before the tragedy.

His previous attempts to give up smoking had failed, but he did not smoke while taking Champix. He became quiet and withdrawn, however, and one day she found him sobbing uncontrollably. "I don't understand how he went downhill so quickly," she said. "He was not the type of person who needed picking up but his whole personality changed. He closed himself off completely from everybody. "These tablets did seem to be working. It was just his moods."

He had finished the drug course a week before she last saw him, but had started smoking immediately. "He was more positive than when I saw him previously," she said. "Never ever could I have dreamt he would have done something like that." Last October, TV editor Omer Jama, 39,was found dead at his home in Bolton. He slashed his wrists weeks after starting a course of Champix. Mr Jama had just booked a foreign holiday and had no history of depression.

The European Medicines Agency last month ordered improved warnings to patients over the twice-daily prescription medicine following reports it could lead to depression. Figures from the MHRA show one patient has taken his life while on the drug, two others have attempted suicide and there have been 60 other "suicidal-type suspected adverse reactions" reported.

About 200,000 patients have been prescribed the drug in the UK since December 2006 and it was approved by the Health Service last July.

An MHRA spokesman said Champix, which is made by Pfizer, was being closely monitored. He said: "Giving up smoking can be very stressful. The side effects are suspected. It does not necessarily mean the drugs caused the reaction." 21.1.08

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Sky Sports executive slashed wrists after taking controversial stop-smoking drug - Champix

A television executive killed himself just weeks after starting to take a controversial smoking cessation drug linked to depression. Omer Jama, 39, a Sky Sports editor who had no history of mental illness, was found dead at his home just two months after he began a course of drugs to help him quit his 20-a-day habit. Mr Jama, a video editor with Sky Sports, had slashed both his wrists and stabbed himself in the thigh and stomach.

Julie Evans, a forensic toxicologist, told the inquest into his death: "There is a possibility he could have been influenced by the side effects of the drug." Fears are growing over the safety of the so-called "wonder drug" which has been used by more than 200,000 people in the UK .

Now the family of Mr Jama from Bolton called for more investigations into its safety of the drug after a coroner returned an open verdict into his death. His brother, Ali Jama, 41, said: "It is clear from the evidence of the toxicologist that Champix's influence could have played a part.

"I would like to see more investigation done." Catherine Jama, his wife of 12 years, told the inquest the couple had recently separated on a trial basis but they met regularly and he was his "usual self" and friends said he was happy in the days before his death. He had booked a holiday to Cuba with a friend just days previously to celebrate is 40th birthday and the keen amateur golfer was still on a high after winning a trophy.

"They just weren't the actions of a man who was contemplating suicide," said Mr Jama, aged 41, of London . "He's got no history of depression and was never the sort of person you would see feeling sorry for himself." Coroner Jennifer Leeming said she would be writing to the Committee for Medicinal Products for Human Use which has been monitoring the drug since it was first authorised in September 2006.

Last year the body received 839 reports of adverse reactions and figures showed 46 were linked to depression and 16 patients claimed to have suffered suicidal thoughts. She said she would register Mr Jama's death as an "adverse event" but was satisfied he inflicted the injuries on himself.

She said: "For me to register he took his own life I would have to be satisfied he did the act which led to his death and he knew what he was doing. "On the evidence before me I cannot say that was the case."

The European Medicines Agency, the drug's licensers, issued guidance on Champix's active ingredient varenicline to doctors two months after Mr Jama's death that "updated warnings" were needed to increase awareness of cases of suicidal thoughts.

Champix is the first non-nicotine anti-smoking treatment and works on brain receptors to relieve cravings and nicotine withdrawal symptoms. Manufacturer Pfizer has insisted a direct link between Champix and psychiatric problems has not been officially established and that nicotine withdrawal can lead to mood swings and behavioural changes. A spokesman for Pfizer said: "Depression, rarely including suicidal ideation, has been reported in patients undergoing a smoking cessation attempt.

"These symptoms have also been reported while quitting with varenicline. "A relationship between varenicline and the reported symptoms hasn't been established, but in some reports a link couldn't be excluded."

Anti-smoking drug, Zyban, which is made by GlaxoSmithKline, has also been linked to a number of suicides among patients. 15.4.08

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