Quit-Smoking Drug May Raise Suicide Risk

FDA asks maker of Chantix to revise warning on product label

By Steven Reinberg, HealthDay Reporter
FDA asks maker of Chantix to revise warning on product label.
 

FRIDAY, Feb. 1 (HealthDay News) -- There's increasing evidence that the smoking-cessation drug Chantix is linked to serious "neuropsychiatric" side effects, including agitation, depressed mood and even suicide, U.S. health officials said Friday.

The U.S. Food and Drug Administration has asked Chantix's manufacturer, Pfizer Inc., to make the warning about these potential problems more prominent on prescribing information and on the drug's label. The agency is also working with Pfizer to produce a Medication Guide for patients, officials said.

"We have become increasingly concerned as we have seen a number of compelling cases that truly look as if they are the result of exposure to the drug and not to other causes," Dr. Bob Rappaport, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products, said during an afternoon teleconference.

"These cases involve abnormal behaviors, changes in mood, and suicidal ideation and suicide," Rappaport said.

The FDA knows of 491 cases of suicidal behavior associated with Chantix, said Dr. Celia Winchell, a team leader in the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Of these, 420 are from the United States," Winchell said. "There are 39 that involve completed suicides, 34 in the United States."

According to Pfizer, 5 million patients have taken Chantix, whose generic name is varenicline.

Friday's warning follows a Nov. 20 FDA statement that the agency was "evaluating post-marketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior."

At that time, Pfizer said there had never been a cause-and-effect relationship shown between Chantix and these symptoms. The company also said that part of the problem may be due to nicotine withdrawal.

Last month, Pfizer agreed, after consulting with the FDA, to update packages of Chantix sold in the United States to more prominently display a warning that users should be monitored for suicidal behavior, depressed mood, and other mental health symptoms.

The FDA approved Chantix in May 2006 as a smoking-cessation drug. It acts in areas of the brain affected by nicotine and may ease withdrawal symptoms and block the effects of nicotine if users resume smoking.

On Friday, FDA officials advised patients to tell their doctor about any history of psychiatric illness before starting Chantix. The drug can cause current psychiatric illness to get worse even if it is under control. Chantix may also cause the recurrence of an old psychiatric illness, the officials warned.

Patients should also report changes in mood and behavior to their doctor. Symptoms to look out for include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide, the FDA officials said.

In most cases, these symptoms developed while taking Chantix, but they can also appear after stopping the drug, the officials noted.

"We are continuing with the review process over the next several months as we try to pin down to what extent these problems are being seen with Chantix," Rappaport said.

Vivid, unusual, or strange dreams may occur while taking the drug. Patients may also experience impaired ability to drive or operate heavy machinery, the officials said.

More information

For more on quitting smoking, visit Smokefree.gov.





PERSONAL NOTE:

MY DOCTOR PUT MY HUSBAND ON THIS MEDICATION AFTER A FEW WEEKS WE NOTICED CHANGES WITH BEHAVIOR.  SO PLEASE THIS IS SERIOUS.  I WANT TO WARN EVERYONE I CAN ABOUT THIS MEDICATION.  SINCE THEN MY HUSBAND QUIT TAKING THIS AND IS NOW USING REGULAR NICORRETE WHICH WORKS THE SAME.

IF YOU HAVE ANY QUESTIONS PLEASE FEEL FREE TO CONTACT ME.

BELOW I PUT THE ONLY INFO I FOUND ABOUT THIS CHANTIX.  I NOTICED THEY HAD NO WARNINGS ABOUT PSYCHOLOGICAL DIFFERENCES INTRESTING HUH




THIS IS THE ONLY INFO OUT THERE ABOUT THIS MED


Pronunciation:ver EN e kleen
Brand:Chantix
What is the most important information I should know about varenicline?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect varenicline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


emtStop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Varenicline can cause persistent nausea for up to several months. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What is varenicline?

Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Varenicline may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before taking varenicline?

Before using varenicline, tell your doctor if you have kidney disease.


nopregFDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
nobrfeedIt is not known whether varenicline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
nochildDo not give this medicine to anyone younger than 18 years old.
How should I take varenicline?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

To improve your chances for successful smoking cessation, set a date to quit smoking. Start taking varenicline one week before your planned quit date.

When you first start taking varenicline, you will take a low dose and then gradually increase your dose over the first several days of treatment. Follow your doctor's instructions. Your doctor may occasionally change your dose to make sure you get the best results from this medication.


waterTake this medicine with a full glass of water.
foodTake the medicine after eating.

In most cases, varenicline treatment lasts for 12 weeks. Your doctor may recommend a second 12-week course of varenicline to improve the chance that you will quit smoking long-term.

It is important to take varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is not causing harmful effects, your kidney function may need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.


rtStore varenicline at room temperature away from moisture and heat.
What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. Be sure to take the medicine after eating.

What happens if I overdose?

emtSeek emergency medical attention if you think you have used too much of this medicine. Symptoms of a varenicline overdose are unknown.
What should I avoid while taking varenicline?

There are no restrictions on food, beverages, or activity while using varenicline unless your doctor has told you otherwise.

What are the possible side effects of varenicline?

emtGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Talk with your doctor if you have any of these side effects:

  • nausea (may persist for several months);
  • stomach pain, indigestion, vomiting, constipation, gas;
  • weakness, tired feeling;
  • increased appetite;
  • unpleasant taste in your mouth;
  • headache; or
  • sleep problems (insomnia) or unusual dreams.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect varenicline?

After you stop smoking, the doses of any medications you are using may need to be adjusted. Tell your doctor about all other medicines you use, especially:

  • insulin;
  • a blood thinner such as warfarin (Coumadin); or
  • theophylline (Respbid, Theobid, Theoclear, Theo-Dur, Uniphyl).

There may be other drugs not listed that can affect varenicline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has more information about varenicline written for health professionals that you may read.

What does my medication look like?

Varenicline is available with a prescription under the brand name Chantix. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


 


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.04. Revision date: 8/24/06.

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Comments:

lillpop
Feb. 2, 2008 at 1:49 PM

  I saw this and it sucks. I was taking this (recently thank God) and it REALLY works GREAT!

 NOW THIS! UGHHH!

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molino06
Feb. 2, 2008 at 1:50 PM for now i'm not quiting just seems it really doesn't matter what you do you'll die of some form of cancer

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lillpop
Feb. 2, 2008 at 1:57 PM

  Yea, but my Mom died of lung cancer and believe you me, you don't wanna die from that , also its the only one that has really very little treatment.

 I am TRYING its SOOOO HARD though

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Lisa_K
Feb. 2, 2008 at 11:29 PM I heard a lot of bad stuff about this too. I had one of my close friends whose husband was going to through the same thing, and his doctor prescribed the same medicine. They did some research and found that some people had such severe psychiatric problems that they were contemplating murder. That was scary enough for them and he ended up quitting cold turkey. I definitely agree with you. This drug should not be on the market. Some doctors will prescribe anything to get a buck.

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pumpk...
Feb. 3, 2008 at 9:56 PM THANK YOU for posting this. My quit date is Feb 3 ( tomorrow) and I was joining some quit groups and looking on line about things to help quit. I was going to ask the doc for a script for this drug till I read your post. Thanks Again!!!

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merce...
Apr. 14, 2008 at 9:55 AM Thank you for this post.  I just forwarded to my Dad.  Anyone know how it affects the kidneys or reacts with anesthesia?

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