U.S. FDA releases Chantix video warnings

John (Gold)
John (Gold)

April 2nd, 2008, 12:24 am #1

New Safety Warnings about Chantix
FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depressed mood, suicidal ideation and suicide. The drug can cause an existing psychiatric illness to worsen, or an old psychiatric illness to recur. The symptoms can occur even after the drug is discontinued.

People who are trying to give up smoking often experience mood swings, irritability and other changes in behavior. But as the reports accumulate, it becomes clearer that there is a link with the drug. For example, some of the patients who experienced these psychiatric symptoms hadn't actually quit smoking.

Physicians and patients have to make an informed decision about whether Chantix is suitable, but in order to do that, it's important that they exchange some important information. For example, physicians should inquire about past psychiatric illnesses before they prescribe Chantix, and patients should be educated to volunteer this information. The premarketing studies of Chantix did not include patients with serious psychiatric illnesses, so the safety of Chantix in these patients hasn't been established.

It is also important for everyone involved in the patient's care (including family members and caregivers) to be vigilant about changes in mood and behavior during the treatment. Things to watch out for include anxiety, nervousness, depressed mood, vivid or unusual dreams, and thinking about or attempting suicide. These changes should be immediately reported to the physician.

Patients should also know that the drug can impair their ability to drive or operate heavy machinery.

To help educate patients about all of these issues, FDA is working with Pfizer, the manufacturer of Chantix, to develop a Medication Guide that will be dispensed with each prescription.


Additional Information:

FDA MedWatch Safety Alert. Varenicline (marketed as Chantix). February 1, 2008.
http://www.fda.gov/medwatch/safety/2008 ... arenicline

FDA Press Release. FDA Issues Public Health Advisory on Chantix. February 1, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html
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Joel
Joel

April 3rd, 2008, 3:47 am #2

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Joel
Joel

April 3rd, 2008, 3:48 am #3

This was an important announcement from the FDA yet I have heard nothing in my local media about it.

Here is a video we put out last year that talks about many of these same concerns.
Video Title Dial Up High Speed MP3 audio Length Created
WhyQuit's candid views about Chantix (and Champix) 17.8mb 53.3mb 22.0mb 48:16 10/19/07


John and I continue to get emails often from people who have experienced numerous problems from Chantix. Many of these emails are alarming. If any of you are encountering people using the drug and are having problems, share the FDA information with them. It is amazing how many people ignore early symptoms thinking that they are normal quitting smoking reactions and simply not knowing that there are known risks associated with the drug. The kind of problems that this product is now linked to in some people should not be dismissed or ignored.
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Chipits GOLD.ffn
Chipits GOLD.ffn

April 3rd, 2008, 5:45 am #4

Thank you John And Joel for keeping us up to date on these issues. I always make it a point to print and share the latest about Chantix-Champix (and other FDA alerts that are relevant to my asthma medications) with my doctor and pharmacist. Let's just say, it is ignorant for us to assume that our care providers always receive this information. I am thankful that my doctor, dentist and even my pharmacist not only expect me to research information, they don't belittle nor reject my offerings.
And that includes allowing me to put a small card holder of colourful homemade High resolution WhyQuit's Quit Smoking referral cards PDF file (270k) in their offices.
Our education here is free!
Knowledge is power!
Wendy&Randy-Using our smarts!Healing our parts! for 20 mths. & 16 mths.
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John (Gold)
John (Gold)

April 4th, 2008, 4:59 am #5

FDA pulls video clip
admitting Chantix suicide link
by [url=mailto:john@whyquit.com]John R. Polito[/url][/size]
On Tuesday FDA Patient Safety News released a video clip sharing safety warnings about "serious neuropsychiatric problems" in users of Pfizer's quit smoking pill Chantix, including suicide. Featured yesterday in a WhyQuit article exploring concerns raised by the video, this morning FDA site links to the clip were no longer functional.

The FDA has yet to respond to inquiry as to why the video clip was pulled and whether or not Pfizer played any role in the FDA's decision to do so.
A copy of the pulled FDA Chantix clip is being made available for viewing at WhyQuit. WhyQuit shares this clip based upon the FDA's Patient Safety News website assertion that, "FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone - either in its entirety or as individual stories."

In a separate development, it's reported that Public Citizen, a non-profit Washington based consumer protection watchdog, has called upon the FDA to require a "black box" warning label for Chantix due to suicide and other behavioral risk factors. Reserved for drugs linked to serious or life-threatening adverse events, a "black box" warning is the strongest warning the FDA can mandate.
XXX

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