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   sci.med.psychobiology      Dialog and news in psychiatry and psycho      4,734 messages   

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   =?UTF-8?B?4oqZ77y/4oqZ?= to All   
   FDA Warns of Seizure, Alcohol Risks With   
   06 Mar 17 16:50:56   
   
   From: mha23x@gmail.com   
      
   FDA Warns of Seizure, Alcohol Risks With Chantix   
      
   Medscape Medical News by Caroline Cassels   
   WebMD News Archive   
   chantix pills   
   March 10, 2015 -- The FDA has changed the labeling on the quit-smoking drug   
   Chantix to reflect concerns that it may lower your tolerance to alcohol and is   
   linked to a rare risk of seizures.   
      
   "Until patients know how Chantix affects their ability to tolerate alcohol,   
   they should decrease the amount of alcohol they drink. Patients who have a   
   seizure while taking Chantix should stop the medicine and seek medical   
   attention immediately," the FDA    
   warns in a news release.   
      
   The new labeling is based on information submitted by Chantix maker Pfizer and   
   on cases in the FDA Adverse Event Reporting System database.   
      
   Some people who drank alcohol during treatment with Chantix had increased   
   drunkenness and unusual or aggressive behavior, or had memory loss.   
      
   The FDA says it also reviewed the database and medical literature for cases of   
   seizures with Chantix. It found cases in which the people who had seizures   
   while taking Chantix either had no history of them or had a seizure disorder   
   that had been well-   
   controlled.   
      
   ADVERTISEMENT   
      
   "In most of these cases, the seizures occurred within the first month of   
   starting Chantix. Information about these risks has been added to the Warnings   
   and Precautions section of the drug label and to the patient Medication   
   Guide," the FDA says.   
      
   The Warnings and Precautions section of the label has also been updated to   
   include information about several studies that looked into the risk for   
   certain side effects on mood, behavior, or thinking that happened with Chantix.   
      
   While the studies didn't show an increased risk of such side effects, “not   
   all types of neuropsychiatric side effects were examined, and the studies had   
   limitations that prevented the FDA from drawing reliable conclusions,” the   
   agency says.   
      
   The FDA also says in its news release that it sent previous alerts about such   
   potential side effects with Chantix in 2009 and 2011. Recent studies on the   
   possibility of these kinds of side effects were discussed at an FDA Advisory   
   Committee meeting in    
   October 2014.    
      
   In 2009, the FDA began requiring a “black box warning” on Chantix warning   
   of behavior changes including “hostility, agitation, depressed mood, and   
   suicidal thoughts or actions.”   
      
   The FDA says Pfizer is doing a large safety trial of Chantix to investigate   
   this risk. Results from this study are expected in late 2015.   
      
      
   http://www.m.webmd.com/a-to-z-guides/news/20150310/chantix-alcohol-seizures   
      
   --- SoupGate-Win32 v1.05   
    * Origin: you cannot sedate... all the things you hate (1:229/2)   

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