Pfizer New Zealand
 

 

Pfizer New Zealand

Mrs Maida Talhami
Manager - Media Communications

Tel: (0800) 699 276
ContactUs.NewZealand@Pfizer.com

Important news for New Zealanders - Pfizer stands behind Champix. 

 Thursday, 29 May 2008

   

Important information for New Zealanders

 

Chantix® (varenicline) is marketed as Champix® in New Zealand, for more information about Champix® please visit www.champix.co.nz or www.medsafe.govt.nz.

 

To better inform people about the risk benefit profile of Chantix (Champix) and Pfizer's commitment to continuing to get people to quit smoking, a Pfizer sponsored letter was published in five US new papers on May 29th, 2008.  The letter appeared in the following US publications:  The Wall Street Journal, The New York Times, USA Today, The Washington Post and the Los Angeles Times. The letter is provided below.

 

CHAMPIX® (varenicline tartrate) is a prescription medicine used as an aid to smoking cessation. Consult your doctor to see if CHAMPIX is right for you. Do not take this medicine if you are pregnant, if you are under 18, using other stop smoking medicines, or have an allergy to the active or other tablet ingredients. Precautions: people with kidney disease or those undergoing haemodialysis treatment, mental illness or a history of mental illness, a history of repeated fits or convulsions, or women who are breastfeeding.Some people have reported changes in behaviour or mood when they start taking CHAMPIX.  These may include depression, agitation, thoughts of self-harm, self-harm or harming others.  It is not known whether these are related to CHAMPIX.   Patients attempting to quit smoking with CHAMPIX and their families should be alerted to the need to monitor for these symptoms and to report such symptoms immediately to their doctor.Possible side effects include nausea, headache, difficulty in sleeping, abnormal dreams, dizziness, weakness, constipation, indigestion, bloating, dry mouth, vomiting, increased appetite and changes in taste. If you have side effects see your doctor.  Always read the label and use strictly as directed.You will need to pay for this medicine and normal doctor’s fees will apply. Contains varenicline 0.5mg & 1mg. Further medicine details are available at www.medsafe.govt.nz. Pfizer New Zealand LTD PO Box 3998, Auckland. Level 3 Pfizer House, 14 Normanby Rd, Mt Eden Auckland.

 

Pfizer’s Message on Chantix (Champix)

 

A message about Chantix® (varenicline) from Pfizer …


You may have seen recent media reports on Chantix, Pfizer’s prescription medication to help people quit smoking.

Here are some important things you should know:

We are committed to patient safety. We conduct extensive research on our drugs in development and we continue to monitor their safety after they are approved. In fact, in close collaboration with the FDA, we recently implemented a change to the Chantix labeling so that patients and health care professionals have the most up-to-date guidance.

Chantix has been prescribed to more than 6 million people worldwide since its launch in August 2006 and has been approved for use in more than 70 countries.

We believe that the benefits of Chantix outweigh the risks, and that safety information about Chantix is appropriately reflected in the product’s labeling.

We are committed to furthering our knowledge of Chantix. In clinical studies of more than 6,000 patients prior to approval of Chantix, 44% of patients who used Chantix and received counseling over a 12-week period successfully quit smoking, versus 18% for a group given a placebo and counseling.

We continue to study Chantix. Additional clinical studies are underway to help us better understand how Chantix works in smokers with special health conditions, including those with schizophrenia, emphysema, chronic bronchitis and heart disease.

There are few things that provide greater health benefits than quitting smoking. Smoking is the leading cause of preventable disease and premature death in the United States with more than 438,000 U.S. deaths annually attributable to smoking. Smoking also causes a number of cancers, is a risk factor for cardiovascular disease, harms nearly every organ in the body and diminishes health generally.

Just this month, the Public Health Service Guideline on Treating Tobacco Use and Dependence was updated. The Guideline underscores the important role of healthcare professionals and doctors in helping patients to quit smoking.

We encourage smokers who want to quit to talk to their doctor or healthcare professional.

If either you, your family or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if you develop suicidal thoughts or actions, stop taking CHANTIX and call your doctor right away. Some patients reported these symptoms while trying to quit smoking with CHANTIX or after stopping CHANTIX. Also tell your doctor about any history of depression or other mental health problems, which may worsen while taking CHANTIX.

The most common side effects are nausea, sleep problems, constipation, gas and vomiting. If you have side effects that bother you or don’t go away, tell your doctor.

Patients also reported trouble sleeping, vivid, unusual or strange dreams. Use caution driving or operating machinery.

CHANTIX is for adults 18 and over and should not be taken with other quit-smoking medicines. You may need a lower dose of CHANTIX if you have kidney problems or get dialysis. Before starting CHANTIX, tell your doctor if you are pregnant, plan to become pregnant, or if you take insulin, asthma medicines or blood thinners. Medicines like these may work differently when you quit smoking. Should you slip up and smoke, keep trying to quit.

Please see next page for Patient Medication Guide and visit www.chantix.com for full prescribing information.


Dr. Joseph Feczko

Chief Physician

Pfizer Inc.


 

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (US Patients Only)

or 0800 675 229 (NZ Patients)


 

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