The new study, published in the Canadian Medical Association Journal, included the results of 14 random, blinded clinical trials that monitored cardiovascular health in more than 8,000 patients taking either Chantix or a placebo. Collectively, the trials found that 52 smokers in the Chantix groups suffered a heart attack, stroke, or other serious cardiovascular event while just 27 smokers taking placebo experienced the same cardiovascular problems. According to the New York Times, the “weighted, relative difference” between the two groups was 72 percent.

In the real world, the findings of these two latest Chantix studies mean that “doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug,” the New York Times reported.

“We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A.,” said Dr. Curt D. Furberg, a Wake Forest professor of medicine and senior author of the new report. “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.”

Dr. Furberg said that there were safer ways for smokers to quit and called for Chantix to be removed from the market.

“It piles up,” Dr. Furberg told the New York Times. “I don’t see how the F.D.A. can leave Chantix on the market.”

The study’s lead author, Dr. Sonal Singh, an assistant professor of medicine at Johns Hopkins University, said that since Chantix gained market approval in 2006, both Pfizer and the FDA have ignored signs that it might be linked to increased cardiovascular risks.

“The F.D.A. should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

“This would have raised a red flag for us if the flag hadn’t already been flying,” Dr. Celia Winchell, a leader in the FDA’s Center for Drug Evaluation and Research told the New York Times. However, short of a recall, the new findings are likely to have little impact on the FDA’s treatment of Chanitx because the drug already carries the agency’s strongest black-box warnings.

Since its debut, Chantix has been prescribed to 13 million people. Last year, the drug earned Pfizer $775 million in sales.

SOURCE: Chantix Recall › Chantix significantly increases cardiovascular risks, according to another new study

“People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away,” The FDA warns in its latest announcement.

The FDA also urges friends and family members to be observant of those using the medications, watching for behavioral changes in particular. The FDA said observers noticing such changes should “tell the person their concerns and recommend that he or she stop taking the drug and call a health care professional right away.”

Health officials are reluctant to withdraw smoking cessation drugs from the market even if the drugs prove to be dangerous for many people because smoking is the leading cause of preventable death in the U.S. Instead of an outright ban, they recommend taking the drugs with extreme caution.

In addition to boxed warnings on product labeling, the FDA will also require all adverse risks to be described in the drugs’ Medication Guides. The same regulations will also apply to generic versions of Zyban.

According to the FDA, analyses of both Chantix and Zyban users revealed disturbing patterns, noting that while many people stopped experiencing adverse affects once they discontinued the medication, others “continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.”

The FDA also said it will require the drug manufacturers to conduct new clinical trials to determine how frequently serious neuropsychiatric symptoms occur in patients undergoing various smoking cessation therapies. To help discern whether the drugs cause the symptoms or merely exacerbate them, the trials will include patients with and without psychiatric disorders.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Sources: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm

http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm169988.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm

SOURCE: Chantix Recall › FDA now requiring stronger warnings on Chantix labels

Health Canada

Last month we reported that Health Canada was preparing to strengthen warnings on Chantix labels. However, Health Canada still has not taken action.

In a report by the Canadian Broadcasting Corporation, Health Canada sent the CBC an email saying that “new advice for health professionals and Canadians will come in the near future.”

Meanwhile, Chantix continues to jeopardize the lives of many Canadian citizens, some of whom are not aware of the drug’s risky side effects.

According to the CBC report, Hamilton resident Erin Kerr had been taking Chantix for two months when she realized her personality had shifted and she had become intolerant, argumentative, and emotional, all of which were unlike her usual self.

Then one day the changes became even worse. Kerr found a sudden irrational appeal in taking her own life. She described her experience to the CBC.

“As I’m driving along the [Hamilton] mountain brow, I just thought that driving off … would have been the easy way out at that point and would solve all my problems,” she said.

Fourteen-year-old Ellaina Janewicz lost her father Thom Janewicz early last month when he committed suicide. His ex-wife, Gayle Nakamoto, said that Thom had struggled with depression in the past, but that it seemed to be “under control.” Thom was a 48-year-old engineer and was about to begin a new job when he started taking Chantix.

Ellaina keeps a journal to help her cope with her loss. She read an excerpt of it to the CBC.

“What will I do now? I have no father,” Ellaina said, reading from the journal. “I’m here with my mother alone and my brother. I’m very confused. I’m not sure what to do.”

In the United States, the Food and Drug Administration strengthened its warnings a year ago. Despite the new warnings, however, the FDA still received more reports of adverse effects linked to Chantix use than any other drug.

SOURCE: Chantix Recall › More Canadians harmed by Chantix as government revises warnings

The decision to turn the volume up on Chantix warnings follows several months of reports linking the drug to a slew of negative side effects. Feeling unusually agitated, depressed, or hostile are some of the effects commonly reported. Sudden changes in behavior, impulsive or disturbing thoughts, and the desire to hurt oneself or others are some of the more serious reactions reported.

In the United States, the Food and Drug Administration received more reports of serious injuries arising from Chantix than for any other drug. Prescription drug related death, which normally accounts for 16 percent of all serious reactions reported to the FDA, soared to 23 percent in the first quarter of 2008, largely because of Chantix. The U.S. has since strengthened warnings on Chantix labels.

Health Canada says that while Chantix can be an effective aide in quitting smoking, users of the drug and their families should closely monitor behavior for any changes. Sudden shifts in mood, depression, aggression, and thoughts of self harm are red flags that everyone should watch for. The person taking Chantix should avoid driving and operating heavy machinery until they know that Chantix does not have any adverse effects on them, Health Canada recommended.

Pfizer’s spokesman in Canada, Christian Marcoux, said that Chantix is safe and that some of the adverse side effects are actually caused by quitting smoking.

SOURCE: Chantix Recall › Canada strengthens Chantix warnings

Chantix became available in the UK in December of 2006. Since then, nearly 400,000 prescriptions for the drug have been written.

Karen McGhee, a resident of Greenock on Scotland’s western shore, was one of those Chantix users. McGhee had been taking Chantix only a few days when she attempted to kill herself.

The McGhee’s daughter found Karen and ran to get her father’s help, shouting that her mother had hung herself.

“I just got woken up with my daughter dragging me out of my bed to come downstairs,” Karen McGhee’s husband, Robert, said.

He found his wife hanging from the stairs in the hall of their home.

“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,” he told the BBC.

“I just couldn’t comprehend it. I thought I was dreaming.”

Karen McGhee spent several days in the hospital hooked up to a ventilator before finally recovering from the incident.

She vowed to avoid Chantix in the future. “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,” she told the BBC.

Another Chantix-related incident occurred in the city of Manchester in northern England. Omer Jama, who the BBC describes as a “young Manchester man,” slashed his wrists. His brother Ali called the incident “a random act, completely out of character, that took an instant.”

Omer Jama did not survive the incident. He did not leave a suicide note and his death was not recorded by the coroner as a suicide.

According to Ali Jama, the coroner recorded Omer’s death with an open verdict rather than issuing the verdict of suicide because forensics revealed Omer had Chantix in his blood at the time of his suicide.

The coroner researched the toxicology results and learned of the possible links between Chantix and suicidal behavior.

More than 3,000 people have reported adverse reactions to Chantix across Britain. 260 of those reactions have been classified as suicidal in nature. 16 Chantix users attempted suicide and 10 killed themselves, the BBC reports.

SOURCE: Chantix Recall › BBC investigates Chantix suicides in the UK