Sunday, May 22, 2011

Chantix Lawsuits, Here We Come. What Are The FDA and Pfizer Smoking?

Chantix lawsuits here we come.  I've been prescribing Chantix and helping fill out the forms for free Chantix on my patients for several years now.  Chantix is one medicine used to help get patients to kick the habit for good.  Does Chantix help to quit smoking?  Yes it does.  It helps take the cravings away.   If nothing has helped, Chantix might be your last hope.  As a hospitalist, I always offer Chantix therapy as an option for all my smokers.  With the average cost of cigarettes going through the roof, the percentage of Americans who smoke has come down.  For those still hanging on, taking Chantix to help quit seems like a perfect opportunity to put down the cancer sticks forever.  Until the nicotine vaccine becomes widely available I just don't think  many other options are successful.  

However, now it seems like Chantix lawsuits may be the next greatest get rich scheme for smokers every where.  On May 19th, 2011 the FDA responded to a report from the QuarterWatch: 2010 Quarter 3  Institute of Safe Medication Practices report regarding the safety profile of Chantix .  You can view the Chantix information on this pdf file starting on page 14.     Pfizer sent the FDA information  on several thousand  Chantix adverse  drug events (ADEs) resubmitted to the FDA'a Adverse Events Reporting System in July 2010 at the FDA's  request.  These events reportedly had been previously submitted in a form that did not allow for a comprehensive evaluation.

These included 150 completed suicides dating back to 2007 along with hundreds of incidents of psychosis, depression and attempted suicide.    In the third quarter of 2010, varenicline had  1,055 serious adverse drug events reported, more than any other drug the ISMP montitors and Chantix ranked first with twice as many deaths reported related to Chantix exposure. 

Pfizer said they were unable to respond to the findings of the ISMP because of their possible involvement in future legal cases.  Here is the FDA response statement to the ISMP QuarterWatch report:  Chantix lawsuits, here we come. I think all hospitalists should be aware of these significant findings.  Should we stop prescribing the drug? I don't know.  Some hospitalists would rather have their patients die a slow and painful death filled with morbid disability spread over many years than to have one  knocked off with a successful suicide attempt.  Pick your poison, I guess. There's always cold turkey available too.
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