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Chantix 57 articles

Chantix linked to increased heart risk

The smoking cessation drug Chantix (varenicline) may be linked to an increased cardiovascular risk, according to a retrospective analysis of medical records of nearly 57,000 new users of the drug. The study, published in the journal American Journal of Respiratory and Critical Care Medicine, found that new users of Chantix had a statistically significant (34 percent) increased risk of being treated in an emergency department or being hospitalized for a cardiovascular event while taking the drug, compared to an observational period prior to starting Chantix. In a group of Chantix users who had not had a previous cardiovascular event, patients ... Read More

GSK Marketed Drugs Despite Flawed Studies, Whistleblower Retaliation Suit Claims

A former clinical researcher for GlaxoSmithKline (GSK) has filed a whistleblower retaliation lawsuit against the pharmaceutical giant, alleging it fired him for repeatedly voicing objections to flawed studies involving the smoking cessation product NiQuitin and other products. Alexandre Selmani, who joined GSK in 2006 as a manager of biostatistics for smoking reduction and cessation, filed the lawsuit in Morris County, New Jersey Superior Court under the state’s Conscientious Employee Protection Act, which provides protections for whistleblowers who expose fraud and other wrongdoing. Mr. Selmani alleges that GSK’s testing of NiQuitin oral strips was marred by mistakes and that his repeated ... Read More

Advocacy groups want stronger Chantix side effects warnings

Public watchdog groups are petitioning the federal government to put stronger warnings on the labels of the anti-smoking drug Chantix. The plea comes one week before the Food and Drug Administration (FDA) is scheduled to hear arguments from the drug’s maker that the black box warning for psychiatric problems should be removed. Chantix, made by Pfizer, contains the drug chemically known as varenicline. It works by binding to the places in the brain that are activated by nicotine when people smoke and prevents the “feel-good” brain chemicals that make people feel so addicted. The drug was approved by the FDA in ... Read More

FDA panel to review psychiatric side effects with antismoking drug Chantix

The Food and Drug Administration (FDA) will hold a public meeting in October to review psychiatric and behavioral side effects with Pfizer’s antismoking drug Chantix and how to better manage them. The FDA said it will convene a panel of psychiatric drug experts to conduct the review. The agency will also require Pfizer to conduct additional studies on the drug. Chantix, which contains the active ingredient varenicline tartrate, was approved by the FDA in 2006 to help cigarette smokers kick the habit. It works by blocking the effects of nicotine from smoking on the brain. At the time, it was ... Read More

New warnings added to Chantix label include cardiovascular events, psychiatric symptoms

The safety label for the smoking cessation drug Chantix (varenicline) has been updated to include new warnings about cardiovascular risks. The warning is based on a large, combined analysis of clinical trials that showed more serious cardiovascular events occurred in people who were taking Chantix. The report was released late last year by the Food and Drug Administration (FDA), which added that the risks were uncommon in both the Chantix and placebo groups, and that it is difficult to determine whether the excess risk of serious heart events among patients taking Chantix was due to the drug or simply chance. ... Read More

Analysis finds more serious cardiovascular events in people who use Chantix

More serious cardiovascular events occurred in people who were taking the smoking cessation drug Chantix (varenicline) compared to people who were taking a placebo, according to a large, combined analysis of clinical trials on the effects of Chantix. The Food and Drug Administration (FDA) released the report this week, adding that the events were uncommon in both the Chantix and placebo groups, and the increased risk was not considered statistically significant, thus the agency says it is hard to say for sure whether the excess risk of serious heart events in the Chantix group was due to the drug or ... Read More

Anti-smoking drug Chantix may help other addicts, but at what cost?

Two new clinical studies have found evidence that Pfizers’s anti-smoking drug Chantix (varenicline) may help take the enjoyment out of cocaine and alcohol in much the same way it makes smoking cigarettes feel less desirable, thereby easing addiction and making it easier for users to quit. The news will certainly be welcomed by manufacturer Pfizer, which had counted on Chantix being a major moneymaker before sales of the drug dropped off following reports linking it to cases of suicide and hostile behavior. But numerous other studies and clinical data suggest Chantix is far from being a sound panacea for addictions, ... Read More

UC doctor finds statin drugs may cause anger, hostility in rare cases

Some people taking Pfizer’s smoking-cessation drug Chantix have reportedly experienced fits of hostility. Anti-depression medications and other drugs that work to modify brain activity have also been linked to episodes of violent behavior. But what about statins, the drugs commonly prescribed to lower cholesterol? Can they turn perfectly level-headed, even-tempered patients into raging lunatics? According to a recent article published in Slate, Physician Beatrice Golomb of the University of California San Diego has been busy documenting cases of statin users who believe the drugs provoke in them “severe irritability and violence.” Dr. Golomb has documented thousands of patient anecdotes on ... Read More

Chantix risks are far greater than other stop-smoking drugs, new study finds

The authors of a study published Wednesday in the science and medical journal PLoS One say that Pfizer’s smoking cessation drug Chantix “shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior” than other smoking cessation drugs and methods, and should not be the first choice of doctors and patients. The study also calls on the FDA to strengthen its warnings and emphasize even more the risks of suicidal behavior and depression associated with the drug. The warning should clearly state that the risk of suicidal behavior and depression “are higher with varenicline than with other smoking ... Read More

Chantix significantly increases cardiovascular risks, according to another new study

Last month, the Food and Drug Administration warned of newly discovered cardiovascular risks associated with Pfizer’s popular smoking-cessation drug Chantix. But it turns out those risks, which include higher occurrence of heart attack and other adverse cardiovascular events in Chantix users with heart disease, pale in comparison to the findings of a larger study that found many of the same risks exist in Chantix patients with no heart disease. 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 ... Read More