Personal Injury Law

Chantix Will Carry Mental Health Risk Warning

By Jane Akre

Depression, Suicidal Thoughts

Chantix is a popular smoking cessation drug but soon it will carry an ominous warning about serious side effects.

Reports from users experiencing depression, hostility, agitation, and suicidal thoughts have been submitted to the Food and Drug Administration's (FDA) adverse event reporting system, (AERS).

So many so that today the FDA issued a Public Health Advisory to alert the public that the drug will be required to carry warnings on the packages of Chantix (varenicline) and Zyban (bupropion hydrochloride).  Also included will be a warning about the possibility of injury while driving or operating machinery. 

AERS reports there have been 98 suicides and 188 attempted suicides in Chantix users and 14 suicides and 17 attempted suicides in buproprion users.   The symptoms usually stopped after the drug was discontinued.  Nicotine withdrawl is not without its own problems, so some of the neuropsychiatric symptoms could be due to the addictive drug.

The warning is serious:

People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.

Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away.

IB News reported last May that the Federal Aviation Administration banned use of Chantix for pilots and air traffic controllers. The trucking industry soon followed suit, warning drivers of big-rigs to stay off the drug.

Long linked to vivid dreams, it is increasingly found to increase psychotic episodes, dizziness, seizures, heart irregularity and diabetes. 

The drug makers, Pfizer, and GlaxoSmithKline, will be required to conduct a tougher clinical trial to determine these symptoms in patients trying to quit smoking.

Pfizer has already updated its label after an investigation into side effects in 2007, reports AP.

The antidepressant Wellbutrin already carries such a warning as it has the same active ingredient as Zyban.

Patients are warned that doctors should continue to monitor their reaction to the medications closely if they continue their use, as they are effective in quitting smoking.  #

Full post as published by InjuryBoard on July 01, 2009 (boomark / email).