FOR IMMEDIATE FREE RELEASE
Wednesday, April 2, 2008
Charleston, South Carolina
Contact: John R. Polito
Note: Between 4/2/08 and 4/3/08 the FDA terminated its website's Chantix video clip links. A saved copy of the video was uploaded to WhyQuit and made available for viewing at this link: Pulled FDA Chantix Video. But on some unknown date prior to June 17, 2008, for some unknown reason, the FDA decided to restore and put back the original video clip which is now functional at the below links.
Yesterday, April 1, the FDA released a video clip containing a Chantix safety warning about "serious neuropsychiatric problems" in users, including suicide. The clip raises more questions than answers. The FDA's new safety warning release, with links, is reproduced in full below and available at the following link: New Safety Warnings About Chantix
The quit smoking pill varenicline is marketed as Chantix in the U.S. and as Champix in the rest of the world. Never in history has any quitting product produced such horrific side effects stories as are being played out among Chantix users.
The new FDA video clearly states that Chantix has been "linked" to suicide while openly admitting a glaring defect in the FDA's drug approval process, that it allowed Pfizer, Chantix's maker, to market it to groups excluded from clinical trials. "During the pre-market studies of this drug people with serious psychiatric illnesses were not included and that means that the safety of the drug in these populations is really not known," the FDA's spokesman states.
He suggests that "physicians and patients have to make an 'informed decision' about whether Chantix is suitable." But how is informed decision making possible so long as the FDA fails to disclose information critical to informed decision making? For example, results from a new study pitting Chantix against the nicotine patch highly suggest that the real-world effectiveness of Chantix, when used as a stand-alone quitting aid without counseling or support, is probably not much better than the nicotine patch's dismal 7% six-month quit smoking rate.
Does the FDA's silence in this video clip on the question of Chantix's effectiveness suggest to smokers that the FDA believes that Chantix is so effective that a decision to use it is intelligent, even when faced with a risk of death?
In light of the FDA asserting that a product marketed to save lives may actually claim them, while suggesting that acceptance of a risk of death by using Chantix can be an informed and sound decision, does the FDA have ethical and legal duties to be honest in disclosing significant Chantix risk and performance information? Here are a few questions the FDA needs to answer:
- Would informed decision making benefit by physicians and users having ongoing access to current and accurate figures regarding the number of attempted and successful suicides in relation to the number of prescriptions written?
- The FDA knows that Chantix clinical trials established records for the most counseling/support contacts (24-25) in any quitting product studies ever. It knows the Pfizer's studies were designed to generate the most newsworthy long-term results ever. It knows that U.S. Guideline evidence tables suggest that these 24-25 contacts could account for nearly all of Chantix's performance. Would informed decision making benefit by the FDA warning users that unless Chantix is used with ongoing counseling and/or support that its worth as a quitting aid may not be much better than quitting without it?
- The FDA has long known that Chantix studies were not blind as claimed and that allowing marketing use of clinical efficacy victories over placebo is likely deceptive. Would informed decision making benefit if the FDA were to reveal to smokers that it has no data indicating that Chantix studies were blind, that it has reason to believe they were not blind, and that if not blind efficacy outcomes over placebo users may be meaningless?
- The FDA's new video clip revealing that those with serious psychiatric illnesses were excluded from clinical trials implies that this was the only group excluded. Would informed decision making benefit by advising patients and physicians as to all other unstudied health conditions that resulted in 28% of study applicants being excluded from Chantix clinical trials?
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.
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Last updated June 18, 2008
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