No end in sight for the negative and extremely disturbing news about Pfizer’s alleged stop smoking drug Chantix (Champix in Europe):

The blood thinner Heparin as well as the alleged smoking cessation drug Chantix accounted for the major share of 21,000 reports of serious drug reactions that the Food And Drug Administration received in the first 3 months of this year alone!

This was concluded after an analysis by the Institute For Safe Medications Pratices.

Please also refer to the "Chantix / Champix" section of this blog for more information and the history on this topic.

For detailed information on a completely safe and highly effective way to quit smoking with my breakthrough hypnosis technique browse the pages of this website.

- Franc Tausch, PhD, CCHT

The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

”The FDA is aware of the increasing number of reports, and we take them seriously,” said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

”We believe that one of the most important tools to promote is to monitor trends on a regular basis,” said Thomas J. Moore, a senior scientist with ISMP. ”Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety.”

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency’s monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths.

Heparin ”illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood,” the report said.

Not so with Chantix, it concluded.

The FDA should forcefully warn patients taking Chantix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

The agency received 1,001 reports of serious injuries linked to Chantix, more than for the 10 best-selling brand name drugs combined.

Chantix ”continued to provide a striking signal of safety issues that require investigation and action,” the report said. The authors acknowledged Pfizer’s concern that publicity may be driving up the number of reports, but concluded there’s enough evidence to warrant stronger FDA action.

[Click below for the entire article]

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The Federal Aviation Administration, FAA, bans the alleged smoking cessation drug for pilots and air traffic controllers, after an extremely disturbing report by the Institute For Safe Medication Practices.

Here is an important quote from the institute’s study:

"We have immediate safety concerns about the use of [Chantix] among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury".

Drug maker Pfizer reported worldwide sales of close to a billion dollars in 2007 for "Chantix"!!! Are you really surprised that the drug has not yet been taken off the market all together?

Please read my archived blogs on the controversy surrounding the alleged Stop Smoking pill "Chantix"  ("Champix" in Europe) here

- Franc Tausch, PhD, CCHT

The Federal Aviation Administration on Wednesday banned pilots and air traffic controllers from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other problems that posed risks to both users and others.

The drug, marketed as Chantix, has been hailed as an innovative treatment to help smokers quit. But a study by a medical safety group — also issued Wednesday — linked it to a variety of unusual and serious side effects, including seizures and loss of consciousness, and prompted the FAA to act, agency spokesman Les Dorr said.

The aviation agency had approved the drug last summer, before federal safety regulators began investigating reports of serious psychiatric problems, including suicidal behavior, sharp shifts in mood and vivid nighttime episodes some patients call "Chantix dreams."

A new warning came from a report by the Institute for Safe Medication Practices, based on an analysis of "adverse events" reported to the Food and Drug Administration.

"We have immediate safety concerns about the use of [Chantix] among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury," the study said.

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You can find a lot of information about the alerts and controversy surrounding the quit smoking drug Chantix -or Champix, in Europe- right here on my blog. Just click on the Chantix / Champix button on the navigation menu on the left for an overview.

Luckily, my post today does not report another casualty. It is a scary yet compelling account of a writer’s first-hand experience with the smoking cessation medication.

The following are some paragraphes I selected from Derek De Koff’s powerful article. You can find it in it’s original length in the current issue of ‘New York Magazine’.

- Franc Tausch, PhD, CCHT

The most unsettling thing about sleeping on Chantix is that I never felt like I was truly asleep. Some part of me remained on guard. It was more like lucid dreaming, what I thought it might feel like to be hypnotized. And it didn’t entirely go away come morning. As I showered, shaved, and scrambled into clothes, I tried to shake a weird, paranoid sense that I’d just been psychically raped by a household appliance. . . .

On January 25, Pfizer was able to share some good news: Japan—where 40.2 percent of all men still smoke—had green-lighted the manufacturing and marketing of its smoking cessation drug. But a few days later, the Chantix news was less cheering. On February 1, the Food and Drug Administration warned that Chantix, which had fourth-quarter sales of $280 million (up from $68 million a year ago), could cause serious psychiatric problems . . .

Public Citizen, a consumer-advocacy group, recommends that people not use Chantix—or most new drugs, for that matter—for seven years. “The first seven years are when problems will occur,” says Dr. Sidney Wolfe, editor of Worstpills.org.

“I remember hearing that argument,” Chatterjee said, a few weeks before the FDA’s new warning was issued. “And it’s just so illogical. If no one uses the drug for seven years, there’s no one to report experiences at the end of seven years—so you’re exactly where you were at the beginning.” . . .

It felt as if the essential barrier between reality and my imagination had eroded. Was it because I wasn’t getting enough R.E.M. sleep, so my dream life was rebelling, pouring into daylight, insisting to be attended to, one way or another?

One afternoon, I was typing away at advertising copy, and as I did so, I began to wonder how I had succeeded in fooling myself that my life had any sort of value at all. . . .

I wondered whether Chantix was zapping my brain’s pleasure-delivery system to such a degree that not only did I find no reward in cigarettes, but I also found no reward in socializing, exercising, writing, or any of my usual self-stimulating tricks. . . .

The next morning, I called in sick to work and started cleaning up the considerable mess I’d made. I had to throw out a bunch of broken CDs, smashed glasses, torn clothes, ripped photographs, and the remaining boxes of Chantix from my medicine cabinet.

It was a good call, I think, the second most important decision I’d ever make in my life.

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Earlier this month, drug maker Pfizer updated the labels for its stop smoking drug "Chantix" ("Champix" in Europe), warning that users should be monitored for suicidal behaviour, depression, and other potential serious side effects.

Only a few days later, yet another suicide is added to the string of fatal tragedies allegedly connected to the highly controversial drug.

Please also read my 3 related blog entries: Smoking Cessation: Another Suicide Blamed On Stop Smoking Drug Chantix , and Stop smoking drug’s side effects may be worse than thought , and Smoking Cessation: FDA Releases over 5,000 Chantix Complaints .

- Franc Tausch, PhD, CCHT

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.

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, MHRA.

"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.

"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.

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."

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I have no intention of turning this blog into an anti-Chantix campaign, but the horror stories about possible fatal side effects of this very controversial stop smoking drug seem to keep pouring in.

Now a man in the UK committed suicide, after suddenly developing depression while on the smoking cessation medication Champix, (the European name for Chantix).

The British Medicines and Healthcare Regulatory Agency, MHRA, disclosed last week that it received nearly 1000 reports of adverse reactions, including depression and suicidal thoughts.

A week ago the U.S. Food and Drug Administration issued a warning about the possibility of severe side effects of Chantix, after receiving more than 5000 complaints.

Please see my blogs FDA releases over 5000 Chantix Complaints and Stop smoking drugs side effects may be worse than thought for more information on last week’s news. - Franc Tausch, PhD, CCHT

The family of a man who killed himself while taking a ”wonder pill" to help him give up smoking have blamed his death on side effects of the drug.

Omer Jama hoped the Champix tablets were the cure that would end his 15-year addiction to smoking - but his family are certain that they led him to take his own life.

Last week American drug safety experts issued a warning about the pill and suicide.

Only four weeks after he began a course of pills to help kick his 20-a-day habit, Mr Jama, 39, a television editor, was found dead with his wrists slashed at his home.

His death came only four days after he was pictured smiling with his newborn niece. He had also recently booked a holiday to Cuba to celebrate his 40th birthday.

Mr Jama’s brother, Ali, said the keen golfer, from Bolton, had split from his wife earlier this year but the pair remained on good terms.

"They just weren’t the actions of a man who was contemplating suicide," said Mr Jama, 41.

"He’s got no history of depression and was never the sort of person you would see feeling sorry for himself.

Up to 200,000 people in Britain have taken the twice-a-day tablets after the treatment was hailed as the most effective weapon in the fight to give up smoking.

It was disclosed last week that the MHRA has received 839 reports of adverse reactions. Forty-six were linked to depression, with 16 smokers claiming to have suffered suicidal thoughts - although no suicides were reported.

An MHRA spokesman said the drug was now being closely monitored, with doctors warned to keep an eye on patients.

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This post is an addition to my blog Smoking Cessation: FDA Releases over 5,000 Chantix Complaints from November 30, 2007. Please read it, if you have not done so yet.

Here is an important new video by WFAA News8 in Dallas about the highly controversial stop smoking drug Chantix. Click here to view it, as I am unable to put the actual video in this post. - Franc Tausch, PhD, CCHT

The Food and Drug Administration announced last week that they are now investigating whether the stop-smoking drug Chantix is safe. As Janet St. James of WFAA-TV News8 reports, the number and type of side effects might be far greater and more deadly than previously reported.

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In hopes to quit smoking, more and more people are turning to the new and highly controversial smoking cessation drug Chantix.

These folks do not want to trade their cigarettes for suicidal or homicidal thoughts, depression,  erratic behavior - and most certainly not death.

However, after 5157 complaints in just one week, involving the above listed symptoms, the U.S. Food and Drug Administration is now looking into this to determine if the drug is really safe.

Chantix sales for the 3rd quarter in 2007 were $241 million (!), up from $33 million a year earlier. With that much revenue at stake the saga will no doubt continue… - Franc Tausch, PhD, CCHT

Complaints about the drug Chantix continue to mount.

The Food and Drug Administration announced last week that they are now investigating whether the stop smoking medication is safe.

Now News 8 has learned the number and type of side effects might be far greater and more deadly than previously reported.

Over the last two months, Ryann Rathbone said she has received countless e-mails from people thanking her for bringing attention to the possible side effects of Chantix.

"We’ve had people who have e-mailed me that I don’t know telling me about their depression or their aggression on it, or their boyfriend’s aggression on Chantix," she said.

Rathbone’s musician boyfriend, Carter Albrecht, was killed in September after being shot by a neighbor during what she described as a violent hallucination prompted by the drug.

After an initial report on Albrecht’s death, News 8 requested, through the Freedom of Information Act, all the complaints filed with the FDA about Chantix. A computer disc was sent with 5,157 complaints, which were all filed in just one week after the News 8 report aired.

Suicide was reported 55 times. Suicidal thoughts were mentioned in 199 cases and 417 people complained of depression.

There were hundreds of mentions of anger, aggression, amnesia, hallucination and homicidal thoughts.

In California, Chad Huber was arrested after an allegedly unprovoked bar fight. His wife said the father of 6-year-old twins was never violent until starting Chantix.

An FDA spokesperson confirmed they are looking into 100 specific psychotic incidents in the United States.

Even before Albrecht’s death, the FDA said they had planned an investigation based on complaints in Europe where Pfizer sold the drug as Champix since 2006.

Rathbone said it all reinforces her commitment to warn Chantix users to beware and be aware.

"Not just the people who are taking the drug need to be aware," she said. "I think their friends, their family, their coworkers [and] everyone needs to look for behavioral or mood changes."

She said she hopes to save others from the grief she continues to endure.

The FDA is urging doctors to carefully monitor patients on the drug. People should also report side effects to the FDA.

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