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|    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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