The FDA said that a randomized, double-blind, placebo-controlled clinical trial of 700 smokers were given Chantix or a placebo. All of the participating smokers had been previously diagnosed with heart disease. Although results found the risks to be relatively small, after 12 weeks more than twice as many Chantix patients suffered heart-related problems than the placebo patients. Seven out of 353 Chantix patients had a nonfatal heart attack, versus 3 out of 350 of the placebo patients.

Other adverse events reported to be more frequent in the Chantix group included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

The FDA advises that patients taking Chantix should check with their doctor if they have new or worsening symptoms of heart disease, such as difficulty breathing, chest pain or pain while walking.

Shortly after Chantix first became available in the U.S. in 2006, patients began reporting negative side effects to the FDA, most notably for suicidal thoughts and actions. In 2009, the FDA required Chantix to carry a black box warning, the agency’s strongest warning, because of persistent complaints about depression, violent mood swings, vivid dreams and nightmares, and suicidal behaviors.

Source:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm

http://www.chantix-legal.com/news/2009/07/01/fda-now-requiring-stronger-warnings-on-chantix-labels/

http://www.chantix-legal.com/news/2011/05/31/chantix-suicides-and-violence-much-more-common-newly-found-reports-show/

SOURCE: Chantix Recall › FDA warns of new heart risks associated with Chantix

When Thomas J. Moore analyzed data collected from the FDA’s Adverse Events Reporting System (AERS), he found nearly 600 reports of serious adverse reactions, including 150 suicides, were mixed in with 26,000 records of non-serious side effects such as nausea and skin irritations. These “missing” reports, some of which go back to 2006, also include accounts of uncharacteristic aggression and hostility, violent outbursts, severe nightmares, and debilitating depression.

In an interview with MSNBC, Mr. Moore said the situation represents “a major breakdown in safety surveillance.”

Chantix has long been blamed for causing severe psychosomatic distress in people who use the drug to ease the cravings for cigarettes while trying to quit smoking. Even before the additional reports of hostilities and suicides were discovered, Chantix has topped the list of the most dangerous FDA-approved drugs.

“It’s really chilling,” Moore added. “This seems to unleash something in people. It can be violence to anything around.”

Until July 2010, the FDA received 122 reports of suicide linked to Chantix, less than the number of suicides contained in the newly discovered reports. Mr. Moore also found the 589 concealed included 102 cases of hostility and aggression, 156 cases of depression, and 56 cases of possible psychosis.

Although Pfizer willfully included these reports with those of less serious side effects, technically the pharmaceutical giant wasn’t breaking the law. The FDA’s reporting system contains two channels through which adverse reactions are reported by drug companies. The “expedited” channel is for serious and unexpected injuries that drug makers must report within 15 days. The other “periodic” channel is for less-serious and expected adverse reactions, which drug companies must report quarterly.

Believe it or not, the FDA does not require companies to submit new reports of death and serious injury in the “expedited” channel for urgent review when such adverse events are already known to exist. This provision allowed Pfizer to include the suicides, suicide attempts, depression, and violent outbursts in with the less-serious, expected adverse events where they went overlooked.

The reported serious side effects were further obscured when Pfizer combined summaries and individual case reports into a s single text file instead of logging them into the AERS system individually, which dramatically reduced the occurrence of serious side effects linked to the drug.

Just as outrageously, the FDA seems to recognize the flaws in its reporting requirements, but isn’t in a rush to fix them. According to MSNBC, “FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if they’ve previously been identified as expected. First proposed in 2003, that change is still pending.”

U.S. doctors prescribed Chantix 3.2 million times last year to smokers trying to kick the habit. The drug has been prescribed 1.1 million times so far this year.

Source:
http://www.msnbc.msn.com/id/43187290/ns/health-health_care/

SOURCE: Chantix Recall › Chantix suicides and violence much more common, newly found reports show

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.

“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.

Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.

“It appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle,” FMCSA Administrator John H. Hill said in a public statement.

Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.

Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.

SOURCE: Chantix Recall › Researchers recommend new Chantix warnings

“Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions,” Lisicki said. “If not, then the VA secretary must take decisive action to terminate their employment.”

Lisicki issued the off-with-their-heads statement in response to reports (link) that the VA may have acted irresponsibly in its study of Chantix using veterans with Post Traumatic Stress Disorder (PTSD).

The VA originally said that 940 veterans with PTSD were enrolled in the study, but only 143 of them were receiving Chantix. (link) However, The Washington Times revealed the number of PTSD veterans receiving Chantix was actually 68 percent higher than the VA originally acknowledged: 241, as opposed to 143.

Of the 241 test subjects, there were 114 reported adverse effects, including 22 psychiatric events.

The VA also prescribed Chantix to some 32,000 other veterans. From that group, 27 were admitted to VA hospitals for apparent psychiatric disorders. Among those, 11 had attempted suicide, 9 had suicidal thoughts, six suffered from hallucinations, and 1 attempted homicide.

Last month, ABC News and The Washington Times revealed (link) the VA’s failure to notify the study’s veterans about the potential psychiatric hazards of Chantix until three months after the FDA’s initial warnings.

Secretary of Veterans Affairs James B. Peake, M.D. insists that the VA has nothing but the veterans’ best interests in mind in determining courses of treatment. After the joint ABC News / Washington Times broke, allegations emerged implying that big pharmaceutical companies and universities may be funding and compromising VA research and care. Dr. Peake called the allegations “ridiculous.”

Still, Dr. Peake has ordered four internal investigations of the Chantix study and the VA’s general operations, ostensibly to safeguard against repeating similar blunders in the future.

To Lisicki and many veterans, the VA’s neglect in informing PTSD veterans about the dangers of Chantix, followed by the administration’s unapologetic attitude, is inexcusable.

“Professional ethics and common sense just dictate that clinicians would stop their patients from taking the drug just to err on the side of safety for the veterans and their families,” Lisicki said.

If the VA tests Chantix on veterans with PTSD, then how would it be able to determine if the emotional and behavioral problems are caused by the drug or the psychological trauma? Wouldn’t being able to differentiate between two possible causes determine the best course of treatment?

Aren’t our veterans worthy of an administration that treats them with genuine care and, perhaps above all, compassion?

SOURCE: Chantix Recall › More veterans enrolled in Chantix study than originally revealed

Chantix is known to create or worsen several neuropsychiatric conditions including suicidal thought and actions.

All of the 940 veterans in the VA study had been diagnosed with Post Traumatic Stress Disorder (PTSD). 143 of those veterans were selected to receive Chantix. Those veterans were given the drug and $30 monthly payments.

The FDA published its first Chantix warning on Nov. 20, 2007, with subsequent warnings from the FDA and the manufacturer Pfizer. Three months passed, however, before the VA notified all relevant doctors and staff involved in the study, and even then, there was no mention of suicide.

James Peake, Veterans Affairs Secretary, said that the 940 veterans in the study would receive a personal warning letter from him. Another 31,000 additional veterans would receive the same warning, he told The Washington Times.

Peake also disclosed that 26 of the study’s PTSD veterans experienced adverse events, including three reports of contemplated suicide.

The drug’s propensity to ignite suicidal thoughts and actions, especially in patients with heightened emotional and mental volatility, was the central concern of those calling for an end to the VA study.

While the VA does not intend to stop the study prematurely, it has said that it will end the study if necessary. New subjects are not being enrolled in the study.

SOURCE: Chantix Recall › VA warns veterans about the dangers of Chantix

Yesterday, Senators John Cornyn (R-TX) and Barack Obama (D-IL) rebuked the VA and demanded an investigation. Both the White House and VA officials dismissed the criticism, with White House deputy press secretary Tony Fratto calling the story an example of “irresponsible reporting.”

Today, however, more congressman are voicing their anger over the study, demanding answers, and calling for action.

Congressmen Bob Filner (D-CA), who is Chairman of the House Committee on Veteran Affairs, together with Rep. Ed Markey (D-MA), and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veteran’s Affairs. In it, they voiced their alarm over the reported allegations and demanded copies of paperwork involved in the studies.

“Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans,” said Rep. Markey today.

The Congressmen sate in their letter, “When you’re taking advantage of a very vulnerable population, people who have served the country, and the agency that’s responsible for their welfare isn’t putting their welfare first, that’s a pretty serious breach of ethics.”

SOURCE: Chantix Recall › Outcry grows over VA Chantix tests