FDA Issues Health Advisory On Pfizer's Chantix Tablets

[Celebration]

http://online.wsj.com/article/SB120189673998036071.html?mod=googlenews_wsj

WASHINGTON -- The Food and Drug Administration said it is "increasingly likely" that Pfizer Inc.'s smoking-cessation drug Chantix may be tied to serious psychiatric symptoms. The FDA's comment is part of a public health advisory issued Friday.

The public health advisory highlighted warnings issued by Pfizer last month stating that Chantix users should be monitored for suicidal behavior, depressed mood and other changes in behavior.

On Jan. 18, Pfizer said it would update the product label for Chantix to more prominently display post-marketing reports of adverse events that were first added to the product label last November after the FDA conducted a preliminary assessment of reported side effects.

Such reports included depression, changes in behavior and suicidal thinking in some patients within days or weeks after starting Chantix treatment. At the time, the FDA said the role of Chantix wasn't clear.

Now, the FDA said, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."

[lligrd]

1. Someone Should Crosspost In The Smoking Cessation Group nt

[juno jones]

2. Doesn't surprise me.

My hubby tried chantix in one of his attempts to break a 20-odd year addiction. He quit taking them about two weeks into treatment because he was noticing some of the same symptoms listed above.

[TZ]

3. Lets bear in mind that not the amount of people

who take this drug and experience these side effects are not a huge percentage. This drug works wonders for the people I know--including my 2 pack a day for 40 years stepfather who tried EVERYTHING else. Also THIS IS WHY WHEN YOU ARE ON PRESCIRPTION MEDS YOU MAKE SURE YOU KEEP ALL DOCTOR APPOINTMENTS!!! Doctors are aware of potential side effects and their main job is to monitor said patients for these side effects.
But knowing the OP of this piece as I do, even if one person experiences side effects than the drug should be BANNED.
While unproven crapola like "chakra balancing" needs to be done at ALL hospitals.
But what do I know? I am only a biologist who sees data on drug clinical trials every day and understands the statistics behind side effects...Of course I don't have a degree in googling....
Here's my commentary here about the OP who only posts the worst news she can dig up on modern medicine:

[Celebration]

4. excuse me?

You don't know me AT ALL.

I barely want anything banned. I didn't even want Vioxx banned. I just think people should know the potential side effects before taking the drug, and that is it.

[xchrom]

5. god, i want to recommend your post so MUCH!!!

:applause:

[BuddhaGirl]

7. hmmm project much?

"But knowing the OP of this piece as I do, even if one person experiences side effects than the drug should be BANNED."

I didn't see anything in the OP that mentioned banning anything.

OTOH - you seem to have this great need to tout your credentials in a good many of your posts...why is that? I think some chakra balancing or other internal work could be very beneficial! :hi:

[lizerdbits]

6. Chantix was like a miracle for me

Gums, patches, welbutrin, nothing worked but this did. My only real problem was having trouble sleeping and staying asleep (which I already had a slight problem with).

It would be interesting to see some numbers on how often this is happening and I don't have a problem with a warning making doctors more aware of it. I wonder if it's more common in people with a history themselves or family history of mental illness, or maybe some other factor is involved. I have a personal and family history of moderate/severe depression but had no problems in that regard. I hope they track patients with this side effect and see if there is a correlation there. Were some already mildly depressed and this just exacerbated it?

Just a note about the depression though and this is just from my experience quitting. When you've smoked a long time it's like your best friend and when you quit it's like your friend has left you. Now it's not a severe depression but more like a loneliness type of feeling and I'm not sure I would even classify it as 'depression', and certainly not even close to suicidal.

[Warpy]

8. Your experience is typical

but a very small percentage of people who have taken Chantix have experienced more severe symptoms, which is why the FDA is issuing the warning.

It just underscores the necessity of keeping in touch with the prescribing physician and reporting all side effects, whether you think they're connected with a drug or not.

Trust me, I've been on the clinical trials end and on the end of experiencing really weird side effects as a patient. All side effects are reportable and they all get back to the FDA eventually.

By the way, smoking might have been your constant companion, but it was not your best friend.