Parker Waichman LLP

New FDA Alerts on Chantix

he US Food and Drug Administration has just approved the Medication Guide on the smoking cessation drug, Chantix, and has issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix.  Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and […]

he US Food and Drug Administration has just approved the Medication Guide on the smoking cessation drug, <"https://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix, and has issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix.  Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide.  Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.

Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior.  And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit.  The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.

While some have experienced neuropsychiatric symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet stopped smoking.  Generally, neuropsychiatric symptoms developed during Chantix treatment; however, in others, symptoms began after stopping Chantix therapy.  Chantix, approved in the US in 2006, blocks nicotine receptors to the brain.  Chantix is the first such nicotine receptor partial agonist approved by the FDA and was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

The FDA warns that if you or your family or caregiver notice agitation, depressed mood, or changes in behavior not typical for you, or if you have suicidal thoughts or actions, stop taking Chantix immediately and call your doctor.  The FDA first informed the public about the possibility of serious neuropsychiatric symptoms last November when information about such symptoms was added to the “Post-Marketing Experience” section of the prescribing information.

As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”  It was because of this that the FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information.

In the US, 34 Chantix users have reportedly committed suicide.  According to an FDA November 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness; however, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism Mr. Silverstein and Ms.Michelle Josama were excellent! Both were very knowledgeable about the case that we brought to them. We were very comfortable throughout this process and would retain their services in the future.”
Jason Bivens
3 years ago
5 Star Reviews 150
I am very grateful for the extraordinary service I received at Parker Waichman. Thanks to Melissa and Jorge for all their help
Blas Diaz
a year ago
5 Star Reviews 150
Thank you very much for helping me get my money but special thanks to Jorge who was always ready to help me with my case, sorry I must make a strong criticism of Michael who never helped me and complicated the process for me, I think he no longer works with this office, thank you Mil Jorge I will give you 5 and up to 20 stars for your work
Alvaro Sanchez
6 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038