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FDA Issues New Chantix Heart Risk Warning

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December 13, 2012 – Pfizer’s blockbuster smoking cessation drug Chantix (generic: varenicline) may increase the risk of users developing serious cardiovascular events, according to a warning issued this week by the U.S. Food & Drug Administration (FDA). A meta-analysis ordered by the agency found a higher occurrence of myocardial infraction (MI), stroke, and death among Chantix users compared to test subjects who took a placebo. In addition to cardiovascular complications, Chantix has recently been linked to  joint and muscle pain, suicidal thoughts, depression, panic, agitation, lack of concentration and psychotic behavior.

What’s the problem?

The results of the recent Chantix study are similar to those described in a drug safety communication issued by the FDA last year. Chantix warning labels will be updated to reflect the results of the new research, the FDA said.

Manufactured and marketed by pharmaceutical giant Pfizer, Chantix is designed to block the effects of nicotine on the brain. The FDA issued its first Chantix safety alert in June 2011 about the increased risk of cardiovascular problems that had been linked to the drug. The administration ordered Pfizer to conduct additional research about possible heart risks associated with Chantix.

Doctors have been advised to carefully weigh the risks and benefits of taking Chantix with their patients before prescribing the drug. The FDA noted in its press release that:

  • smoking is a known cause of heart disease;
  • Chantix has been proven to be helpful to those who wish to quit smoking;
  • quitting now brings quick and significant health benefits.

If you are currently taking Chantix, you should contact your doctor immediately if you develop new or worsening symptoms of cardiovascular disease, which may include chest pain, shortness of breath, calf pain, numbness, sudden weakness, or difficulty breathing. Patients with questions or concerns about Chantix should consult their physician.

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