Chantix was approved by the FDA on the basis of five studies, all funded by Pfizer .
Thursday, January 3, 2013
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.
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