FDA Issues New Warning about Chantix Heart Attack Risk Ava Lawson | December 27th, 2012 | Posted in Chantix Lawsuit News

Chantix Heart Attack WarningBased on the results of wide scale clinical studies, the FDA has issued another safety communication concerning the potential dangers of Chantix. The December 12, 2012 alert advises consumers to contact their physician if they experience new or worsening symptoms of cardiovascular disease while taking the medication. According to medical research, a higher incidence of adverse cardiovascular events was observed in patients using the smoking cessation medication compared to those who were given a placebo. The agency ordered drug maker Pfizer to update the warning label to reflect the increased risk of Chantix-related heart attack. The FDA first notified the public about potential risks of cardiovascular complications with Chantix in a June 2011 safety communication. Many who have suffered injuries after taking the drug have consulted a Chantix lawyer to discuss their options for legal recourse. Injured patients encouraged to contact a Chantix lawyer The updated Chantix (varenicline) warning label now cautions: “Patients taking Chantix should contact their health care professional if they experience new or worsening symptoms of cardiovascular disease, such as chest pain, shortness of breath, calf pain when walking, or sudden onset of weakness, numbness, or difficulty speaking. Patients should also contact their health care professional if they have any questions or concerns about Chantix.” The label also warns health care professionals to weigh the risks of Chantix against the benefits of its use. While the drug may be effective in helping patients quit smoking, almost 2,000 former varenicline users have filed a Chantix side effects lawsuit against Pfizer claiming the drug caused alarming neuropsychiatric effects ranging from aggressive behavior and suicide ideation to hallucinations and extreme paranoia. In light of these dangerous side effects, a Chantix lawyer may help injured patients recover monetary damages in the form of a jury award or out-of-court settlement. Heart attacks linked to Chantix Meta-analysis studied by the FDA integrated data from 7,002 patients who were registered in 15 Pfizer-sponsored, double-blind, placebo-controlled clinical trials. While the occurrence of major cardiovascular adverse events (MACE) among the Chantix group was small, the evidence still suggested a correlative link between the medication and potential heart problems. The cardiovascular safety of Chantix was also examined in a study published by the Canadian Medical Association Journal (CMAJ) in July 2011, which demonstrated Chantix users were 72 percent more likely to develop heart problems than patients taking a placebo.

Facing Monday trial, Pfizer settles bellwether Chantix case October 18, 2012 | By Tracy Staton Pfizer ($PFE) settled its first lawsuit over Chantix's links to suicide, Alabama media reports. After failing to win a postponement earlier this week, the drugmaker made a deal with the plaintiff, a Minnesota woman whose husband killed himself while using the stop-smoking drug. The terms were undisclosed. It's the first of the Chantix bellwether suits, the leading edge of the litigation over the drug's psychiatric risks. Some 2,600 claims were filed nationwide linking Chantix with suicides, attempted suicides, and other serious psychiatric problems, but all those cases are now consolidated in an Alabama court. Pfizer had asked Judge Inge Johnson to put off the trial until January to give the company time to work in new data from a trial of Chantix in depressive patients. That data made its debut Tuesday. Johnson rejected Pfizer's motion; the settlement followed. Attorneys in the case had also asked the judge to compel Pfizer CEO Ian Read to take the stand. The next case up for litigation was filed by Billy G. Bedsole, Jr., an Alabama man who claims that Chantix triggered suicidal thoughts, erratic behavior, mood swings, anxiety and memory loss. He says he was hospitalized for psychiatric reasons after using the drug. Read more: Facing Monday trial, Pfizer settles bellwether Chantix case - FiercePharma http://www.fiercepharma.com/story/facing-monday-trial-pfizer-settles-bellwether-chantix-case/2012-10-18#ixzz29mSwdNk5 Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma Lets hope the heart attack cases go as smoothly !!!

Pfizer Fails to Bar Expert Witness Testimony in Chantix MDL Cases Lance Andrews | September 4th, 2012 | Posted in Recent Settlements Drug manufacturer Pfizer has had a motion dismissed in the pre-trial process for pending Chantix suicide lawsuits. Pfizer attempted to bar expert witness testimony for the plaintiffs, which was rejected by the federal judge on August 21, 2012. This means that these experts can testify about the psychological risks, such as depression and suicidal thoughts, that occur while individuals were taking smoking cessation drug Chantix. The Chantix settlement amounts demanded by each plaintiff are officially in excess of $75,000, though if the cases are successful, the amounts awarded are likely to be far greater. Chantix lawyer files case in California The lawsuit of Saul Frazier v. Pfizer was first filed in the Superior Court of Los Angeles County. At the request of Pfizer, the case was then transferred to the United States District Court in the Central District of California. On March 2012, the case was then transferred to the United States District Court for the Northern District of Alabama. This federal lawsuit is part of a multidistrict litigation (MDL), a group of consolidated lawsuits which will be presided over by Judge Inge P. Johnson. Chantix violence, other side effects spur lawsuits against Pfizer In 2006, the Food and Drug Administration (FDA) approved the drug Chantix (varenicline) for use in the United States. This prescription medication was meant to help people quit smoking by reducing the pleasurable effects in the brain that come from smoking. In 2009, the FDA issued a requirement that a black box warning be added to the Chantix drug label, which was intended to let people know about the risk of psychological problems. Some of these included increased hostility, depression, and thoughts of suicide. Thousands seek Chantix Settlement Amounts Drug manufacturer Pfizer currently faces approximately 2,600 lawsuits, which have been filed on behalf of those who have been severely injured due to psychological problems, including those who have committed suicide. In 2011, the FDA issued another warning of an increase in heart problems in people taking Chantix. According to a report published in the PLoS ONE medical journal in January 2011, researchers from the Cambridge Hospital and the Institute for Safe Medication Practices found that Chantix was linked to violence in over 400 reported cases. This research was conducted over a five-year period, and focused on adverse event reports submitted to the FDA through the year 2009. Researchers have stated that the primary cause of Chantix violence is an increase of dopamine to the brain instigated by the drug. In July 2011, the same researchers issued a report outlining the risk of aggressive and violent behavior of Chantix users, but indicated that these side effects quickly disappeared after discontinuing use of the drug.

Story of Biased Chantix Study by Pfizer-Funded Author Gets Worse; Article Violates FDA Recommendations, Excludes Heart Attack and Stroke Events, and Doesn't Adequately Consider Low Power of Studies

Thursday, May 10, 2012

Monday, I discussed the results of a re-analysis of a previous study that showed an increased risk of adverse cardiovascular events among patients receiving Chantix. The new study concludes that Chantix is perfectly safe for use in patients in terms of cardiovascular risk. One of the authors of the new study is a recipient of grant funding from Pfizer, the manufacturer of Chantix, and therefore has a significant financial conflict of interest. I have previously argued that: "The bias present in the study has the appearance of being a result of this conflict of interest."

Today, I reveal several more dimensions of this story.

First, as Dr. Sonal Singh points out in his rapid response to the re-analysis, it appears that the authors excluded from their analysis several severe adverse cardiovascular events that have already been reported, including by the FDA itself. As Dr. Singh notes: "For example, in the largest clinical trial, the Rigotti study, the authors recorded 10 events in each treatment arm. In contrast, the updated FDA label, which contains warnings about an increase in cardiovascular risk associated with varenicline in patients with cardiovascular disease, notes several more treatment-emergent cardiovascular events during 30 days in varenicline than placebo [in this same study]: “These include treatment emergent events (on treatment or 30 days after treatment of angina pectoris (13 patients in varenicline arm vs 7 in placebo arm), and the serious cardiovascular events of non-fatal MI (4 vs 1) and nonfatal stroke (2 vs 0).”"

These exclusions presumably occurred because the authors did not count any adverse events that happened more than 30 days after discontinuation of the drug. However, the FDA-mandated clinical trial to assess the cardiovascular risks associated with Chantix required that follow-up of treated patients for adverse cardiovascular outcomes must continue out to at least one year. Thus, the study violates the FDA's recommendation that a one-year follow-up period is necessary. Apparently, the FDA is concerned that adverse effects of Chantix could occur well after discontinuation of the drug.

And well they should be. We all know about the severe cardiovascular adverse events associated with Vioxx use. Vioxx was in fact pulled from the market because of these effects. It is critical to note that these adverse cardiovascular effects of Vioxx persisted up to one year after discontinuation of the drug. How does it make any sound scientific sense, then, to exclude events occurring more than 30 days, but less than one year, after discontinuation of Pfizer.

This dimension of the story seems to make the apparent bias of the study even more striking.

Second, I do not believe that the article appropriately considers the lack of power in the clinical trials to detect a significant increase in a rare, serious adverse event such as heart attacks. These studies were powered to detect differences in smoking cessation between treatment arms, not to detect differences in rare adverse events. Pfizer itself notes that these clinical trials should not be used for conclusive evidence on whether the drug poses cardiovascular risks. Speaking about one clinical trial, Pfizer notes: "The study was powered for assessing efficacy (ie quit rates) but not for assessing differences in the occurrence of serious CV events between CHAMPIX and placebo. Therefore, the study was not large enough to allow conclusions regarding the difference in the incidence of CV events reported in the two arms."

In this light, it is difficult to understand how the paper could conclude not only that there was no statistically significant increase in risk, but also that there was no clinically significant increase. As I pointed out yesterday, even a 0.27% absolute increased risk would translate into thousands of adverse events because of the large number of patients being treated with the drug. And if the drug is not particularly effective in achieving smoking cessation, then the risk-benefit analysis could easily tip towards the risk side.

Even if one accepts the results of the article at face value, the upper end of the confidence interval for the risk difference was 0.63%. This means that because of the small sample sizes in the clinical trials, this meta-analysis cannot rule out an effect as large as a risk difference of 0.63%. With 1.8 million annual prescriptions for Chantix, however, this excess risk of 63 events per 10,000 treated patients would be quite significant. To conclude definitively that there is no clinically significant cardiovascular risk associated with Chantix based on the meta-analysis thus appears to be quite biased.

Finally, while the article does not provide details of the purpose for which the conflicted author is receiving funding from Pfizer, it turns out that this funding is for a clinical trial of Chantix among hospitalized smokers. In my opinion, this makes the conflict of interest even stronger.

Clearly, the verdict is not yet in and an investigator who has a conflict of interest by virtue of taking money from Pfizer for a clinical trial of Chantix should not draw a conclusion at this point in time, based on the existing under-powered clinical trials, that the drug has no clinically significant cardiovascular risks.

Safety Alerts for Human Medical Products Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

Safety Alerts for Human Medical Products Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

http://open.salon.com/blog/xylocopa/2011/05/29/chantix_is_suicide_an_expected_eventChantix was approved by the FDA on the basis of five studies, all funded by Pfizer and published in July and August of 2006. The designers of these studies seem to have pulled out all the stops in their efforts to stack the deck in Pfizer’s favor.

As many as one-third of prospective study participants were turned away for conditions including but not limited to a history of cancer, cardiovascular disease, chronic obstructive pulmonary disease, a history of alcohol or drug abuse, major depression, panic disorder, bipolar disorder, systolic blood pressure greater than 150 or diastolic pressure greater than 95, a body mass index of less than 15 or higher than 38, weight less than 45kg, those with "clinically significant abnormalities in the screening laboratory values…” The list goes on and on.