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Chantix Will Carry Mental Health Risk Warning

Posted by Jane Akre
Wednesday, July 01, 2009 6:25 PM EST
Category: On The Road, Major Medical, Protecting Your Family
Tags: Smoking Cessation, Zyban, Chantix, Suicide, FDA, Depression

Chantix will carry a stronger warning label concerning the risk of suicidal thoughts according to the FDA.

Depression, Suicidal Thoughts

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IMAGE SOURCE: Pfizer, Chantix Web site 

 

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.  #


4 Comments

Anonymous User
Posted by carly
Wednesday, July 01, 2009 8:22 PM EST

First the Percocet and Vicodin problems and now this. Time for changes at the FDA. There is a related post at LINK

Anonymous User
Posted by kat
Thursday, July 02, 2009 4:39 AM EST

Re: "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."

Gosh, it sure seems like that should've been done BEFORE this drug was launched and before the commercial began to run every 3 minutes on just about every station.

Also, does anyone else find it strange that the other smoking cessation drug mentioned in the article, ZYBAN is ALSO prescribed as an antidepressant under a different name--Welbutrin...and that ZYBAN/WELBUTRIN is being investigated and black-labeled because it can actually CAUSE depression and suicidal thoughts?

I smoke, and I hate it, and I'm going cold-turkey. I'd rather suffer the consequences of going cold-turkey than turn my brain chemicals over to a bunch of crooked, dishonest, swindling drug companies who seem to have a way of getting their products approved even though they are seriously flawed.

The approval process seems to be based on the FDA closing their eyes, looking the other way and approving these drugs that haven't been properly tested and that are often backed up with questionable or outright faked-up science.

Whose hand is in whose pocket?

Posted by Jane Akre
Thursday, July 02, 2009 8:38 AM EST

I think we are seeing the first efforts of a new FDA so fasten your seatbelts - more changes are coming, hopefully for the better.

Posted by Darren Wilson
Thursday, July 02, 2009 9:35 AM EST

Gosh, I hope you are right, Jane. If people only we aware of the preventable deaths, illnesses and injuries that result from sloppy, lax, overworked, underfunded and sometimes corrupted government health and safety regulatory agencies, they'd be marching in the street for better oversight.

Comments for this article are closed.

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