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Entries in Chantix (3)

Thursday
Nov032011

FDA Should Warn Smokers of Increased Psychological Dangers of Chantix, Study Says

Brand X Pictures/Thinkstock(WINSTON-SALEM, N.C.) -- Scientists say the U.S. Food and Drug Administration (FDA) should take warnings about the stop-smoking drug Chantix up a notch, citing data showing that the drug increases suicidal behavior and depression far more than other drugs and methods designed to help smokers quit.

Chantix, also called varenicline, has been hotly debated since 2007, when experts first raised questions about the long-term safety of the drug and its connection to cardiovascular problems and vision lapses.  Since then, studies have reported that patients taking Chantix are at increased risk of depression and suicidal thoughts.  Anecdotally, patients report wild dreams, inexplicable violent behavior and other psychological disturbances while on the drug.

In 2009, the FDA placed a "black box" warning label on Chantix and another drug, Zyban, cautioning doctors and patients about the risk of depression, hostility and suicidal thoughts.

But some researchers say these warnings don't go far enough.  On Thursday, a study published in the journal PLoS One continued to sound the alarm against Chantix and urged the FDA to update Chantix's warning label, saying the psychological risks of the drug exceed those of nicotine replacement drugs or even its competitor, Zyban.

Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the study's authors, said people trying to kick their tobacco habit generally are at higher risk for psychological symptoms, but Chantix makes them far worse.

"The dramatic increase of these symptoms is caused by the drug.  Among all the treatments we have for smoking cessation, Chantix is the worst," Furberg said.

In the study, Furberg and his colleagues analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban, or nicotine replacement drugs, which were reported to the FDA through its Adverse Event Reporting System from 1998 through September 2010.  Of those reports, 90 percent were linked to Chantix.  In reports of completed suicides of people taking these stop-smoking treatments, the study said 92 percent were associated with Chantix.

The FDA is unmoved by this latest report. A spokeswoman for the agency said the drug is a safe and effective way to help smokers quit.  Additionally, the agency noted that this latest study failed to account for an uptick in reports of psychological side effects from Chantix that occurred as media coverage of the drug increased since 2007.

Pfizer, Chantix's manufacturer, also took issue with the data Furberg and his colleagues used in their study, saying that their reports of negative side effects are unreliable.

Pfizer also noted that at the FDA's request, the company is conducting a clinical trial to study the link between Chantix and psychological side effects.  The results are expected in 2017.

Copyright 2011 ABC News Radio

Tuesday
Jul052011

Use Chantix to Quit Smoking and Risk Your Heart?

Brand X Pictures/Thinkstock(BALTIMORE) -- On the heels of the U.S. Food and Drug Administration's admission that Chantix, Pfizer's smoking cessation drug, may aggravate heart problems in those with cardiovascular disease, new research suggests that they're not the only ones at risk.

Chantix may in fact increase the risk of heart attack and other adverse events for those with a clean bill of cardiovascular health.

Though concerns over Chantix's effect on the heart were raised during the drug's approval process in 2006, the FDA's recent move to include a cardiovascular warning in the drug's safety information marks the first time the organization has publicly discussed such potential risks.  It's a move that is a long time coming for Dr. John Spangler, co-author on the new research, a meta-analysis published Monday in the Canadian Medical Association Journal.

Since 2007, Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine in Winston-Salem, North Carolina, has been attempting to get the word out concerning possible cardiac and other safety concerns for those taking Chantix, but his prescient warnings were largely ignored until recently.

"I had spoken to JAMA and LANCET and people from Pfizer, and emailed the FDA, and no one was very interested or concerned about the things I was finding," Spangler says.

Spangler's meta-analysis, done with lead author Dr. Sonal Singh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine, could stir concern too loud to be pushed aside, however, especially in light of the FDA's reconsideration of Chantix's safety profile.

Study authors looked at 14 past studies of Chantix and found that overall, people on the drug had a 72 percent increased risk of being hospitalized with a heart attack or other serious heart problems when compared with those taking a placebo.

"In the proportion of smokers that had never had heart disease, we saw an even greater risk of adverse events, about 150 percent increased risk," says Singh.

"The main goal of smoking cessation is to reduce the risk of heart attack that comes with being a smoker, but this drug is doing the exact opposite.  It's increasing the risk of what they're trying to avoid," Singh says.

The most "frustrating" part, he adds, is that the Food and Drug Administration found an increased risk for cardiac events back in 2006, "but they did not warn patients or physicians at that time that it may be a risk. They didn't put it on the label," Singh says.

According to the FDA, however, the data Singh refers to was too inconsistent to warrant a label mention -- until recent studies suggested it might be true.

Copyright 2011 ABC News Radio

Tuesday
May312011

Pfizer Accused of Under-Reporting Side Effects of Stop-Smoking Drug

Brand X Pictures/Thinkstock(WASHINGTON) -- Everyone knows smoking cigarettes can kill you, but so might drugs that are supposed to help you kick the habit.

While severe side effects from the smoking-cessation drug Chantix have been documented for years, it turns out that suicides resulting from using the product made by Pfizer Inc. were actually more than twice in number than the pharmaceutical company admitted.

It's all there in a new analysis by the Institute for Safe Medication Practices (ISMP), which says that there were 150 instances of Chantix users taking their lives out of the nearly 600 delayed reports of severe issues noted in the study.

The Food and Drug Administration contends that Pfizer covered up the actual number of suicides by submitting information through "improper channels."  As a result, the FDA wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts.

One ISMP scientist said of the data, "It’s really chilling.  This seems to unleash something in people.  It can be violence to anything around.  We’ve had a major breakdown in safety surveillance."

While Pfizer says it will comply with the FDA request, the company contends there's no concrete evidence Chantix causes suicides.

Last year, the drug was prescribed 3.2 million times worldwide.

Copyright 2011 ABC News Radio







ABC News Radio