Parker Waichman LLP

FDA Modifies Chantix Label for Heart, COPD Patients

The Chantix label has been updated with new information regarding the safety and efficacy of the smoking cessation medication, according to an announcement from the U.S. Food & Drug Administration (FDA). The modifications to the Chantix label apply to patients with pre-existing heart disease and chronic obstructive pulmonary disease (COPD). The new Chantix label will […]

The <"https://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix label has been updated with new information regarding the safety and efficacy of the smoking cessation medication, according to an announcement from the U.S. Food & Drug Administration (FDA). The modifications to the Chantix label apply to patients with pre-existing heart disease and chronic obstructive pulmonary disease (COPD).

The new Chantix label will now include information from a randomized clinical trial of 700 smokers with cardiovascular disease. According to the FDA, while the study found that Chantix was effective at helping such patients stop smoking, it also demonstrated that Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in these patients. Information regarding the heart events seen in the trial was added to the “Warnings and Precautions” section of the Chantix label last month. Healthcare professionals should always weigh the potential benefits of Chantix against its potential risks when deciding to use the drug in patients with heart disease, the FDA said.

The label modification also includes the addition of a study that showed that Chantix was more effective in helping COPD patients quit smoking and remain abstinent from smoking for as long as one year compared to placebo. Adverse events in this clinical trial were similar to those seen in studies that were conducted for Chantix’s initial approval in 2006, and no new safety concerns were identified, the FDA said.

Finally, new directions have been added to the label for patients who select a quit smoking date after they have already started taking Chantix. According to the FDA, the new label states that such patients should start taking Chantix seven days before their quit date or, alternatively, begin the drug and then quit smoking between day eight and day 35 of treatment.

Since being approved by the FDA in 2006, Chantix has been prescribed to 13 million people. The drug has long been controversial because of its association with psychiatric side effects, including suicidal thoughts and behavior. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label because of such problems. The drug has since been named in numerous personal injury lawsuits.

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: Responsiveness I would like to complement my only contact person at your firm. Her name is Ashley Lopitlato her kind reassurances sustained me through times of worry and doubt she made the wait far more bearable. Thank you, Ashley
R Nagle
3 years ago
5 Star Reviews 150
robert francis
3 years ago
5 Star Reviews 150
The Office staff at Parker Waichman has been extremely responsive to all of my questions and concerns, someone is always checking in with me to see how we are feeling, how treatments are going, it puts your mind at rest and they don't allow you to stress out about the small details because they take care of all of them. I am very grateful to have Joanne, Jillian and Cristen helping my family through this. Even the reception staff are always cheerful and pleasant, it is such a pleasure speaking with them.
Kathy Oliva
8 years 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